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Clinical Trials: What You Need to Know



Why Do We Need to Conduct Clinical Trials?

What Are Preclinical Studies And Clinical Trials?

What Are the Phases of Clinical Trials?

Who Sponsors Clinical Trials? Who Conducts Them?

Should I Think About Taking Part in a Clinical Trial?

Who Will Look Out for Me as a Participant?

What’s Out There? Finding Clinical Trials

How Do I Figure Out Which Study Is for Me?

What About Cost? Will My Insurance Cover It?

What Would Participating Involve for Me?

What If I’m Not Eligible for a Clinical Trial?




Choosing whether or not to take part in a clinical trial can be one of the toughest decisions facing a person with cancer.

Clinical trials are people-based studies — as opposed to animal or lab studies — of new drugs or procedures. Doctors use clinical trials to learn whether a new treatment is safe and effective in patients. Such trials are vital to the development of new treatments for diseases such as cancer.

The doctors in charge of the study don’t know ahead of time how things will turn out. If they did, there would be no need for the study in the first place. And because the doctors don’t know how things will turn out, they really can’t answer the patient who asks, “Should I take part?”

Most people don’t pay much attention to clinical trials until they are diagnosed with a serious illness such as cancer. You may have seen stories in the news about something going wrong in a clinical trial. The media is quick to pick up on an instance when a volunteer in a study is harmed. While it is very rare, people have been harmed, and have even died, while taking part in clinical trials. This is even more tragic when it could have been prevented. Reports of these tragic outcomes are important, because they help to expose problems in the system, which are then corrected to protect others.

What you usually don’t hear about, however, are the thousands of people who are helped each year because they decided to take part in a clinical trial, not to mention the millions who ultimately benefit from others’ participation in clinical trials.

There is no right or wrong choice when it comes time to decide on taking part in a clinical trial. The decision is a very personal one and depends on many factors, including the benefits and risks of the study, what the person hopes to achieve by taking part, and other preferences.

Knowing all you can about clinical trials in general — and ones you are considering in particular — can help you feel more at ease with your decision. If you do decide to participate, knowing what to look for and what to expect ahead of time can help you.

This guide should address many basic questions and concerns so that you are better prepared to discuss the subject with your doctor and family. It should clarify which questions need to be asked beforehand and what the answers may mean for you. In the end, however, only you can decide if taking part in a clinical trial is right for you.

One last note: Clinical trials are conducted in all areas of medicine, including ways to prevent and diagnose diseases, but this guide focuses on studies for people who have cancer. However, most of the information here applies to other types of clinical trials as well.

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Why do we need to conduct Clinical Trials?

Clinical trials show us what works (and what doesn’t) in medicine. They are the best way for doctors to decide what is safe and effective in treating diseases such as cancer.

Some doctors and scientists conducted what would now be considered clinical trials as far back as the late 1700s, but clinical trials were not widely used until the middle of the 20th century. Up until that time, doctors relied on their own experience in particular cases and on the teachings of those who came before them. Progress was slow, and very few medicines existed that could even be tested.

With the discovery of the first antibiotics and other drugs, doctors needed a reliable way to tell what worked from what didn’t. They also needed ways to find out which of the countless remedies available at that time were safe for people to use. So they developed studies that tested, and often compared, treatments in a specific group of people. The results of these clinical trials proved to be more useful than relying on whether or not something worked in one or a few people.

n the US, new drugs and medical devices (but not dietary supplements) must be approved by the US
Food and Drug Administration
(FDA) before they can be advertised or sold to the general public. The FDA began overseeing the safety of new treatments in the late 1930s but didn’t require proof of effectiveness until the early 1960s. Today, drugs and medical devices must go through several phases of clinical trials (discussed below) before being approved for use.

Clinical trials are only a small part of the research that goes into developing a new treatment. Drugs, for example, must be discovered, purified, characterized, and tested in laboratories before ever reaching clinical trials. In all, about 1,000 potential drugs are tested before just one reaches the point of being tested in a clinical trial. On average, a new cancer drug has at least 4 years of research behind it before it even makes it to clinical trials. But the major holdup in getting new cancer drugs to market is the time it takes to complete clinical trials themselves. On average, 8 years can pass from the time a cancer drug enters clinical trials until it is approved.

Why so long? To establish safety and effectiveness, researchers examine each new treatment in several different trials. Furthermore, only certain people are eligible to take part in each clinical trial. And cancer trials, by their very nature, take years to complete. It takes months, if not years, to see if a cancer treatment works in any one person.

Recent scientific advances, such as the Human Genome Project, have given us a new window into how the human body works. They have allowed us to develop promising new drugs much faster than in the past. But it’s still a time-consuming and difficult process.

The biggest barrier to completing the trials is the shortage of people who agree to take part: Only about 4% of adults with cancer will do so. According to the Pharmaceutical
Research and Manufacturers of America
(PhRMA), nearly 400 cancer medicines were tested in clinical trials in 2003. Not all of these will prove to be useful, but those that are may be delayed in getting approved because the number of participants is so low.

The number one reason people give for not taking part in a trial is that they didn’t know they were eligible. But there are many other reasons. Some people are uncomfortable with the idea of being a “subject” in a study. Others worry that they won’t be treated fairly or could be harmed by an unproven treatment. Certainly these are understandable concerns. We have addressed them in more detail in the section “Should I Think About Taking Part in a Clinical Trial?”

One of the most important points in deciding if a clinical trial can be done is whether or not it would be ethical to ask patients, many of whom are in desperate situations, to volunteer for an experimental treatment. Has the study been designed, as much as possible, to ensure the safety of the people involved? Would the participants receive a treatment that is at least as good as, and possibly better than, what they would get if they did not volunteer for the study? A scientific review panel and an institutional review board of the participating institution review and approve all clinical trials to make sure questions like these are answered before the researchers are allowed to enroll patients.

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What Are Preclinical Studies and Clinical Trials?

Clinical trials are done only after “preclinical” studies suggest that the proposed treatment is likely to be safe and effective in people.

Preclinical studies, also called laboratory studies, include:

Cell studies: These are often the first tests done when looking at a new form of treatment. To see if it is effective, researchers combine the new treatment with cancer cells on a laboratory dish or in a test tube.

Animal studies: Treatments that appear promising in cell studies are next tested on tumors in laboratory animals as opposed to smaller groups of cancer cells in a laboratory dish. This gives the researchers an idea of how safe the new treatment is in a living organism.

Although preclinical studies provide a lot of useful information, they do not give us all the answers. After all, humans and mice are different creatures. A treatment that works against cancer in a mouse may or may not work in people. And human bodies sometimes process drugs differently. This may result in side effects that were not obvious when studying mice.

Clinical trials are therefore needed to answer 2 important questions:

Is the new treatment effective? Is it better than what’s now available to treat a specific disease? If it’s not better, is it at least as good, perhaps while causing fewer side effects? Or does it work in some people who don’t benefit from current treatments? In other words, is it a step forward? A treatment that doesn’t offer anything new probably isn’t
worth studying.

Is the new treatment safe? This must be answered while
realizing that no treatment or procedure—even one already in use—is entirely
without risk. But do the benefits of the new treatment outweigh the possible

Answering these questions, while exposing as few people as possible to an unknown treatment, often requires several different clinical trials. These are usually divided into “phases.” Each phase is designed to answer certain questions, while trying to ensure the safety of the people taking part. Each new treatment must be tested in 3 separate phases of clinical trials before being considered reasonably safe and effective. These phases are discussed in the next section.

Some Important Points to Keep in Mind

Clinical trials are vital in studying all aspects of medicine, not just cancer. The stakes may seem higher when researching medicines to treat cancer, but all new treatments (drugs and medical devices) must go through clinical trials before being approved by the FDA for general use.

When most people think about clinical trials, they have certain ideas about what they involve. But not all clinical trials are the same.

Not all clinical trials study treatments. Many clinical trials study new ways to detect, diagnose, or determine the extent of disease. Some even look at ways to prevent the disease from happening in the first place.

Even among clinical trials that do study treatments, not all of
them study drugs.
Many clinical trials test other forms of treatment, such as new surgery or radiation therapy techniques, or sometimes even complementary or alternative medicines.

When clinical trials do look at drugs, not all of them study new
. Even after a drug has been approved for use against a type of cancer, doctors sometimes find it works better when given a certain way or when combined with other treatments. It may even work on a different kind of cancer. Clinical trials are needed to study these possibilities.

Not all clinical trials involve a placebo. A placebo is an inactive ingredient or pill used in some types of clinical trials to help make sure results are unbiased. A placebo is sometimes called a “sugar pill.” Over the years, doctors have observed that some people begin to feel better if they just think they’re being treated. With the possibility of getting a placebo, people can’t tell whether they are receiving the treatment being studied or not, which makes the results more likely to be valid.

Placebos are rarely used alone in cancer research, unless no known effective treatments exist. It’s certainly not ethical to have someone take a placebo if an effective standard treatment is already available. When cancer clinical trials compare treatments, they compare the new treatment against the current standard treatment. At times, a study may be designed so that patients may not be told which one they are receiving, but they know they are at least getting the current standard of care.

n some clinical trials, the doctors want to learn whether adding a new drug to the standard therapy improves its effectiveness. In these studies, some patients receive the standard drug and a new one, while other patients receive the standard drug and a placebo. But none of the patients would receive a placebo only. Everyone receives standard treatment if there is a standard treatment available. (See “What Are the Phases of Clinical Trials?” for an example of a phase III study involving a placebo.)

All clinical trials are voluntary. You always have the right to choose whether or not you will take part in a clinical trial. The level of care you receive should not be affected by your decision. And you have the right to leave a clinical trial at any time, for any reason. If you decide to leave, your health care team may ask that you continue to be monitored for a period of time to look for any long-term effects of treatment. We discuss these issues further in the section “What
Would Participating Involve for Me?”

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What Are the Phases of Clinical Trials?

Clinical trials are usually conducted in distinct phases. Each one is designed to answer specific questions. Knowing the phase of the clinical trial you are considering is important because it may give you some idea about how much is known about the treatment being studied. There are advantages and disadvantages to taking part in each phase of clinical trial.

Phase I Clinical Trials – Is the Treatment Safe?

These studies are the first ones to involve people as participants. Although the treatment has been well tested in laboratory and animal studies, the side effects in people can’t always be predicted. For this reason, these studies usually include small numbers of people (15-40) and are generally reserved for those who do not have good treatment options left to them. Often, people with different types of cancer are eligible for the same study. These studies are usually conducted in major cancer centers.

The main reasons for conducting phase I studies are to determine the highest dose of the new treatment that can be given without serious side effects and to decide on the best way to give the new treatment. The first few participants often receive a low dose of the treatment and are then watched very closely. If there are no or only minor side effects, the next few patients receive a higher dose. This process usually continues until doctors find the dose that is most likely to work with the fewest possible side effects.

Safety is the main concern because it is the first time the treatment has been used in people. Doctors keep a close eye on how the participants are doing. Special tests, such as blood tests to measure levels of the drug in the body at certain time points, are often a part of these trials. Some studies may require time in a hospital. Placebos (inactive pills or ingredients) are not part of phase I trials.

These studies are not designed to look at how effective the new treatment is. Overall, these trials are the ones with the most potential risk and the least likelihood of potential benefit. But they do help some patients. For those with life-threatening illnesses, weighing the potential risks and benefits carefully is crucial.

Here’s an example of a typical phase I clinical trial, but keep in mind that studies vary:

Bruce C. was diagnosed with cancer 4 years ago. He was first treated
with radiation therapy, but the cancer was later found to have spread
to distant parts of his body. His doctor told him two chemotherapy drugs, “A” and “B,” might help him. Bruce’s
cancer shrank for a short time while he was taking drug A, but then it
began to grow again. Drug B did not work in his case.

Because Bruce is still relatively young, his doctor suggests he might
want to consider trying a new form of treatment, “EXP1,” which is being
studied in a phase I clinical trial at the nearest university hospital.

Bruce talks with the university doctor conducting the study. The doctor explains that the drug being studied shows some promise, but exactly how well it will work in people is still unknown. What’s more, it may have side effects that haven’t been seen yet. After getting all of his questions answered and weighing his options, Bruce decides to take part in the study

Because 3 people have already enrolled in the study and have had no major side effects, Bruce will be the first to get a higher dose of the treatment. He will need to stay in the hospital overnight on the first night. This is both to watch for any unexpected reactions and to take blood samples every few hours so that doctors can figure out how long the treatment stays in his body. He will be allowed to go home the next day but must return regularly over the next few weeks to be monitored, until it is time for the next treatment.

Phase II Clinical Trials – Does It Work?

If a new treatment is found to be reasonably safe in phase I clinical trials, the treatment can then be tested for effectiveness in a phase II clinical trial.

Usually, a group of anywhere from 25-100 patients with the same type of cancer receive the new treatment in a phase II study. They are treated using the dose and method that were determined to be the safest in the phase I study. In a typical phase II clinical trial, participants all receive the same dose, and no placebo is involved.

Some phase II studies do, however, involve randomizing participants into 1 of 2 treatment groups, similar to what is done in phase III trials (see below). Phase II studies are often conducted at major cancer centers but may also be done in community hospitals or even doctors’ offices.

Doctors look for a response (evidence that the cancer is affected). This may be that the tumor is shrinking or has disappeared. Or it may simply be an increase in the length of time before a cancer comes back. The type of response they look for depends on the goals of the clinical trial. Many studies look to see if people getting the new treatment live longer than they would have been expected to without the treatment.

If a certain percentage of the patients respond to the treatment, it is considered to be active enough against that type of cancer to allow it to go on to a phase III clinical trial. In addition to watching for responses, doctors continue to look for any side effects. Larger numbers of patients receive the treatment in phase II studies, so there is a better chance that less common side effects may be seen.

Here’s an example of a phase II clinical trial. Again, some phase II studies may be slightly different:

Angela D. was diagnosed with cancer several months ago. Only one form of treatment, drug “C,” is known to work for people with her type of cancer, and it only works in about half of the people who try it. After several months of this treatment, Angela’s doctor told her that it did not appear to be working.

After doing a little research online, Angela and her doctor decide her best bet may be to enroll in a clinical trial. They find a phase II study being conducted by a doctor nearby, who is testing a new type of medicine, called “EXP2.” This medicine was already found to be safe in phase I studies. Although not many people have tried it, a couple of people with Angela’s type of cancer were helped by it.

Angela, like all of the other people in this study, will receive EXP2 once a week as an outpatient at a local hospital. Before receiving the drug each week, she will have physical examinations and blood tests done to see how her body is reacting to the medicine. She had similar checkups while receiving drug C, but this time the tests and exams are a little more frequent. Also, her doctor asks more specific questions about the side effects she experiences.

Phase III Clinical Trials – Is It Better Than What’s Already Available?

Treatments that show a certain level of effectiveness in phase II studies must go through one more stage of testing before being considered for general use. Phase III clinical trials compare the safety and effectiveness of the new treatment against the current standard treatment.

Phase III clinical trials require a large number of patients, usually at least several hundred. These studies are generally conducted in many places across the country (or even across the world) at the same time.

Because doctors do not yet know which treatment is better, patients are often randomized (chosen at random, like flipping a coin) to receive either the standard treatment or the new treatment. If patients were allowed to choose their treatment, that decision might be influenced by their general health or the stage of their cancer. And if patients with a more serious prognosis tended to prefer either of the two treatments being compared, the results of the study would be difficult to interpret because the researchers would not know if differences in outcome were really due to the effects of the treatments. When possible, the study is double blinded — that is, neither the doctor nor the patient knows which of the treatments the patient is getting. This is because a patient’s perception of his symptoms, or even his doctor’s interpretation of the patient’s response, might be influenced (intentionally or unconsciously) by their expectations about a particular treatment. If patients or doctors are particularly hopeful about the new treatment, they might be likely to overlook or minimize side effects, or to exaggerate benefits. Double-blinding avoids this possibility and thereby increases the credibility of the study.

As with other studies, patients in phase III clinical trials are watched closely for side effects, and treatment is stopped if they are too severe. At times, placebos are involved in phase III studies, but they are never used alone if there is already a treatment available that may work.

Here’s an example of a phase III clinical trial that could possibly involve a placebo:

Joe B. has just been diagnosed with cancer. His surgeon was able to remove the tumor, but tells Joe that this form of cancer often returns. For this reason, doctors usually recommend chemotherapy drug “D.” While this is the best drug available for reducing the likelihood of recurrence, some cancers still return.

Joe’s doctor tells him that a new type of therapy, called “EXP3,” is now being studied to help people in his situation. EXP3 was designed to be given along with drug D, and the combination of the two is already known to be more effective than drug D alone in shrinking tumors. Not only that, but it’s also been shown to help patients live longer who have advanced cases of the kind of cancer Joe has. But it is not yet known if this combination will be better than the current standard of drug D alone in preventing recurrence of less advanced cancers. Therefore, doctors want to find out in a phase III clinical trial.

To do this, they’ve designed a study that involves treating people with this cancer in one of two groups (that is, there are two “arms” of the study): One group will get drug D plus EXP3, while the other group will get drug D plus a placebo. The patients will be blinded—that is, they will not know whether they are getting EXP3 or the placebo. But all of the patients will be getting drug D, which is the accepted standard of care. The people who get EXP3 may do better than those who get the placebo. On the other hand, they may do worse because of things such as unknown side effects. Or both groups may do equally well, in which case EXP3 would not be any better than a placebo.

Joe, in deciding whether to take part in the clinical trial, needs to understand that he will be randomized to one of the two treatment arms, and neither he nor his doctor will have control over this.

Participants are randomized to ensure that the two groups have the same traits—for example, to make sure that they both contain people in similar states of health, so the results are not skewed in favor of one group. Often people have a 50:50 chance of ending up in one group or the other. In some cases, the study may allow for a different ratio, such as 2/3 of the people receiving the new treatment and only 1/3 getting the standard treatment.

Some people find the concept of randomized studies to be distressing, since neither the patient nor the doctor can choose which group the patient falls into. This can be especially true if a study is looking at two totally different treatments, and a person sees one as possibly better than the other. But remember, doctors are conducting the study because they really don’t know which one is better. Unfortunately, taking part in such a study is sometimes the only way a person may have a chance of getting a new form of treatment. But that treatment may or may not be the best one for him or her.

Blinding is another area of concern for some people. Not knowing what you are receiving can be difficult. Your doctor can always find out which group you are in if medically necessary (such as during a possible drug reaction), but it may result in your being removed from the study.

The possibility of receiving a placebo can also be upsetting to some. But this very rarely means you would get no treatment, unless there was no effective standard treatment to compare the new drug to. Again, in the example above, Joe will definitely get drug D, but he will also get either EXP3 or a placebo.

FDA Approval

When a treatment is shown to be more effective and/or safer than the current standard treatment in a phase III clinical trial, it is submitted for approval to the FDA. Based on the results of the clinical trials, the FDA decides whether or not it is appropriate for use in the general public. When this happens, the treatment often becomes the new standard of care, and newer drugs must be tested against it before being approved.

Phase IV Clinical Trials – Is There a Better Way to Use Them?

Even after testing a new medicine on thousands of patients, usually new questions arise as the studies progress. Would the medicine work better if given twice a week instead of once a week? Are 6 months of treatment better than 4 months? Are there rare side effects that haven’t been seen yet? These types of questions, which may not be critical for getting a medicine to market, are often addressed in phase IV clinical trials.

Phase IV studies look at drugs that have already received FDA approval. Therefore they are already available for doctors to give to patients. These studies, however, are still needed to answer important questions.

When considering taking part in a phase IV trial, patients should know that the drug has already been approved for use. It is not necessary to enroll in the study to get the medicine. At the same time, they should be reassured that in participating they would be receiving a form of treatment that has already been studied extensively and that they would be doing a service to future patients.

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Who Sponsors Clinical Trials? Who Conducts Them?

Of the thousands of cancer clinical trials going on at any one time, the US
National Cancer Institute
(NCI), a part of the National Institutes of Health (NIH), sponsors (pays for the costs of) a good portion of them. These studies are often run by NCI-sponsored cancer cooperative groups, which are networks of doctors and institutions across the country who specialize in a particular aspect of cancer.

There are currently 10 major cooperative groups conducting studies:

  • American College of Radiology Imaging Network (ACRIN)
  • American College of Surgeons Oncology Group (ACOSOG)
  • Cancer and Leukemia Group B (CALGB)
  • Children’s Oncology Group (COG)
  • Eastern Cooperative Oncology Group (ECOG)
  • Gynecologic Oncology Group (GOG)
  • National Surgical Adjuvant Breast and Bowel Project (NSABP)
  • North Central Cancer Treatment Group (NCCTG)
  • Radiation Therapy Oncology Group (RTOG)
  • Southwest Oncology Group (SWOG)

The other main sponsors of clinical trials are pharmaceutical and biotechnology companies, which must show that their medicines are safe and effective before they can be marketed. Other groups, such as some nonprofit organizations, also sponsor clinical trials.

Researchers conduct clinical trials in many different settings. Major cancer centers are the most common; because they usually have the most advanced facilities and highly trained staffs, they can conduct all phases of clinical trials. But they are not the only places where these studies take place.

Community hospitals across the country also participate in clinical trials, although these are usually phase II or III studies. Many of these hospitals are part of the NCI’s Community Clinical Oncology Program (CCOP). CCOP members conduct the same clinical trials across the country. Community hospitals may conduct other, privately sponsored, studies as well.

Doctors in private practice can also be involved in clinical trials, either as members of cooperative groups or by being actively involved in private research. But many doctors decide not to conduct clinical research, for a variety of reasons.

What This May Mean for You

At one time, clinical trials were conducted only at major medical centers. This often meant that patients had to travel long distances and were treated by doctors they did not know very well. This is sometimes still the case, especially with phase I and some phase II studies. Of course, this is not necessarily a bad thing. Many people prefer to be treated in major cancer centers because of their experience, reputation, and resources. Ultimately, the hassles of traveling must be weighed against the chance of benefiting from the treatment.

But patients now have more options. This may include staying closer to home during a study or even staying with their own doctor. Your doctor may or may not be involved in clinical trials. If he or she is, you may be eligible for one. Whether this is the right study for you is, of course, a question worth asking.

Although clinical trials are now done in many different settings, this should not affect the quality of care you receive. No matter where a study is conducted, the same rules are in place to protect patients.

Having so many options can be a burden in and of itself. With the thousands of clinical trials underway across the country, how can you—or even your doctor—decide which one is best for you? At this time, there is no complete list of all the cancer clinical trials. There are, however, several good places to start looking if you’re interested. We’ll explore these in the section “What’s Out There? Finding Clinical Trials”.

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Should I Think About Taking Part in a Clinical Trial?

This is the toughest question many people with cancer will face. The same answer won’t be right for everyone. When trying to decide the best route, first ask yourself some basic questions:

  • Why do I want to take part in a clinical trial?
  • What are my goals and expectations if I decide to participate? How realistic are these?
  • How sure are my doctors about what my future holds if:
    • I decide to participate?
    • I decide not to participate?
  • Have I considered:
    • The chance of benefit vs. risk?
    • Other possible factors, such as time and money?
    • My other possible options?

Some of these questions may not have clear-cut answers, but they should help you start thinking about some important issues. Each person’s situation is unique, and each person’s reasons for wanting or not wanting to participate may be different.

Risk vs. Benefit

Each clinical trial offers its own opportunities and risks. But generally, clinical trials have some of the same potential benefits:

  • Access to treatment that is not otherwise available, which may be safer or more effective than existing treatment options.
  • Increasing the total number of treatment options available to you, even if you haven’t yet received all of the standard treatments.
  • More careful monitoring of your condition and the possible side effects of treatment.
  • The chance to possibly help others who have the same condition in the future by contributing to cancer research.
  • The possibility of payment for part or all of your medical care during the study by some study sponsors. This is not true for all clinical trials, so be sure that you are aware of the costs of your participation.

Some of the potential downsides of participation include the following:

  • The new treatment may have unknown side effects or other risks, which may or may not be more severe than those from existing treatments. This is especially true of early phase trials.
  • As with other forms of therapy, the new treatment may not work for you, even if it helps others.
  • If you participate in a randomized clinical trial, you may not have a choice about which treatment you receive. If the study is double blinded, you and your doctor will not know which one you are getting (although this information is available if needed). This will be explained to you before you decide to take part.
  • Insurers do not always cover all of the costs associated with taking part in a clinical trial. Be sure to talk to your insurance provider before you decide to participate.
  • There may be inconveniences such as more frequent testing, as well as time and travel commitments.

Answers to Some Common Questions About Clinical Trials

Most people have some concerns about taking part in a clinical trial, often because they’re not really sure about what it involves. Gathering as much information as possible beforehand is the best way to ensure that you will make the choice that is right for you.

Will there be risks?

Yes, risks are involved in clinical trials. By the same token, risks are a part of any medical test, drug, or procedure. The risk may be greater in a clinical trial because some aspects of any new treatment are unknown. This is especially true of earlier phase clinical trials, which have included very few people.

A more important question is whether the risks are outweighed by the possible benefits. People with cancer are often willing to accept a certain amount of risk for a chance to be helped, but it is always important to have a realistic idea about the actual chance of being helped.

With this idea in mind, you can make a more informed decision—one that is right for you. Some people decide that any chance of being helped is worth the risk, whereas others choose to be more cautious.

Will I be a “guinea pig”?

There’s no denying that the ultimate purpose of a clinical trial is to answer a medical question. People who take part in clinical trials are research subjects and may be required to do certain things or have certain tests done to stay in the study.

But this does not mean that you will not receive excellent, compassionate care. In fact, most people enrolled in clinical trials appreciate the extra attention they receive from their health care team. In a recent CenterWatch survey, more than 1,000 study participants were asked if they would enter a clinical trial again. Overall, 77% responded “definitely,” 20% answered “maybe,” and only 3% said “no.”

Will I get a placebo?

The vast majority of cancer clinical trials do not involve a placebo unless it’s in combination with another, active, drug. It would be unethical to give someone an inactive medicine if it would deny him or her the chance to get one that has already been shown to work.

Unfortunately, with cancer, some situations have no known effective treatments. In rare cases, testing a new treatment against a placebo might be needed to prove that the treatment is better than nothing at all.

The very least you should expect from any clinical trial is to be offered the standard of care already in use. (See the section “What Are the Phases of Clinical Trials?” for an example of a phase III study involving a placebo.)

Will my information be kept confidential?

To the extent that is possible, all of your personal and medical information is kept confidential in your medical records. Of course, your health care team has access to this information, just as they would outside of a clinical trial.

Some members of the research team may also look at your records, because the study sponsor needs your medical information when submitting data to the FDA while trying to get the treatment approved. Government agencies such as the FDA may also need to view your records in some situations. But whenever possible, you are assigned an anonymous number or code to protect your identity. Your name is not used in any publications of study results.

Other Questions You Should Ask Your Research Team

Each clinical trial is unique, with its own potential benefits and risks. Before you decide to take part in a clinical trial, make sure you have answers to the following questions:

  • Why is this study being done?
  • What is likely to happen in my case if I decide to participate/not to participate?
  • What are my other options (standard treatments, other studies)? What are their advantages and disadvantages?
  • How much experience do you have with this particular treatment? With conducting clinical trials in general?
  • What were the results in previous studies of this treatment?
  • What kinds of tests and treatments does the study involve? How often are they done?
  • Will this require an extra time or travel commitment on my part?
  • How could the study affect my daily life?
  • What side effects might I expect from the study? (Remember that there can also be side effects from standard treatments and from the disease itself.)
  • Will I have to be hospitalized? If so, how often and for how long?
  • Will I still be seeing my regular doctor?
  • Will I have any costs? Will any of the treatment be free? Will my insurance cover the rest?
  • If I am harmed as a result of the research, what treatment will I be entitled to?
  • How long will I remain in the study?
  • Are there reasons I would be removed from the study? Are there reasons the study might be stopped early?
  • Is long-term follow-up care part of the study?
  • Can I choose to continue to get this treatment, even after the study ends?
  • Are there others participating in the study whom I could speak to?

Involving trusted friends and family members may be a good idea. They can help reassure you that you’re making a decision that’s right for you. In addition, getting a second opinion from a doctor who is not associated with the study can give you a broader sense of whether this particular study is the best one to consider.

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Who Will Look Out for Me as a Participant?

Several levels of safeguards are in place to protect the welfare of people who take part in clinical trials. These don’t totally prevent complications, but they do reduce the risk as much as possible.

Three basic principles, as outlined in the Belmont Report from the late 1970s, provide the basis for research involving humans:

  • Respect for persons: Recognizing that all people should be respected and have the right to choose what treatments they receive
  • Beneficence: Protecting people from harm by maximizing benefits and minimizing risks
  • Justice: Trying to ensure that all people share the benefits and burdens of research equally

These principles are upheld by individuals and groups at the sites conducting research and by government agencies charged with overseeing clinical trials. A very important part of patient protection is the informed consent process, which is described in detail in the section “What Would Participating Involve for Me?”

Safeguards in Institutions

Institutions conducting clinical trials have committees that review all potential and ongoing clinical trials to protect the safety of study participants. These are required for all federally funded clinical trials, but even privately sponsored trials usually undergo such reviews.

Institutional review boards (IRBs).IRBs are groups of people responsible for protecting the welfare of study participants and making sure that studies comply with federal laws. They are usually made up of doctors, other scientists, and nonmedical people. Many institutions have their own IRBs, although some use larger, “central” IRBs. The federal Office for Human Research Protections (OHRP; see below) oversees the activities of IRBs.

Researchers wanting to conduct a study must first submit the study protocol (the plan describing the study in detail) to the IRB for review. The IRB must decide if the trial would be ethical – if the potential benefits outweigh the risks. One of the most important functions of an IRB is to make sure the informed consent form that each participant must sign is accurate, complete, and easy to understand. Once a study begins, the IRB also monitors its progress on a regular basis.

Because of limited time and resources, there have been some concerns in the past about IRBs’ ability to effectively safeguard the public. Reforms in the system, including the formation of the OHRP in 2000, are helping to ensure that IRBs do their jobs correctly.

f you take part in a clinical trial, you can contact the IRB directly with any questions or concerns regarding safety.

Data safety monitoring boards (DSMBs). DSMBs are used for phase III (and some earlier phase) studies. They are comprised of doctors and other scientists who look at study statistics. They monitor clinical trials at different points and can stop a study early (before all of the intended participants have been enrolled or completed the study) if:

  • It becomes clear that the new treatment is much more effective, so as to allow all study participants to get the better treatment
  • Safety concerns arise, such as risks of the new treatment clearly outweighing the benefits

The principal investigator (PI). The PI is the doctor who is in charge of all aspects of a particular study. Ultimately, the responsibility for patient safety in a clinical trial lies with the PI. Part of this responsibility is letting the study sponsor know immediately when side effects occur.

PIs generally have years of experience in conducting clinical trials. They are required to submit their credentials to the FDA before being allowed to run any study.

Government Agencies

Several government agencies play roles in ensuring that all research is conducted with patient safety in mind. These include:

Food and Drug Administration (FDA). The FDA has the final say about whether or not a new treatment can be marketed to the public; that is, whether or not doctors can begin prescribing it to their patients. Once all phases of clinical trials on a new treatment are completed, the FDA reviews the information and decides if it is safe and effective enough to be approved.

But the FDA’s role in clinical trials begins long before this. Any sponsor seeking approval for a new treatment must submit all study protocols to the FDA before the clinical trials are allowed to proceed. Researchers who will be involved in the study must submit their credentials for review as well.

The FDA also inspects sites conducting clinical trials, especially if there is reason to think that proper procedures are not being followed. If serious problems are found, the FDA can forbid a particular site or doctor from conducting any further research.

The authority of the FDA is not absolute, however. Clinical trials that study treatments already on the market are not subject to the same FDA regulations. And substances considered to be “dietary supplements” do not need FDA approval to be sold in the first place. Dietary supplement manufacturers aren’t required to prove that their products are safe or effective. Therefore, they usually do not bother with the expense of conducting clinical trials. A relatively small number of clinical trials are conducted to study the effectiveness of dietary supplements; most of these are funded by the National Institutes of Health (NIH).

Office for Human Research Protections (OHRP). The OHRP was established in 2000 to coordinate efforts to protect all people involved in federally funded research. It enforces regulations regarding the informed consent process, IRBs, and the participation of special populations in clinical trials, such as children and those with mental disabilities.

The OHRP has temporarily suspended research activities at several institutions in the last few years, including those in some major research centers, until system flaws were corrected.

National Cancer Institute (NCI). The National Cancer Institute, part of the NIH, sponsors many of the cancer clinical trials going on at any one time, including those being conducted by cooperative groups. Proposals for such studies must be approved by the NCI before funding is granted.

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What’s Out There? Finding Clinical Trials

People find out about clinical trials in different ways. Your doctor may suggest you think about taking part in a study. Some clinical trials are advertised directly to patients. And many cancer patients actively look for clinical trials, hoping to find more options for treatment.

If you already have a particular clinical trial in mind, you may want to go to the next section (“How Do I Figure Out Which Study Is for Me?”) to learn what you should know about the study.

Types of Clinical Trial Information

At this time there is no single place to get information on all of the cancer clinical trials now enrolling patients. But there are several resources you should be aware of. These resources can be divided into two main types — clinical trials lists and clinical trials matching services.

Clinical trials lists can provide the names and descriptions of clinical trials of new treatments for particular diseases. If there is a particular trial you are interested in, you will probably be able to find it in a list, with a description of the treatment being tested and of criteria for determining whether patients are eligible. If you (or your health care providers) are willing and able to read through descriptions of all the trials listed as your cancer type, then a list may be all you need. Some organizations that provide lists can help you narrow the list a little, according to the kind of treatment you are looking for (chemotherapy, immunotherapy, radiation therapy, etc.) and the stage of your cancer.

Over the past few years, several organizations have developed computer-based systems to offer to match patients with studies they may be eligible for. These organizations generally offer their services online, but they may differ somewhat in how they operate. Some of the services allow you to search for trials without registering at the site. Even if registration is required, they usually assure you that the information will be kept confidential. Either way, you will likely have to enter certain details, such as the type of cancer, the stage of your disease, and any previous treatments you may have had. By providing this information, these systems can identify clinical trials for which you are likely eligible, and save you the time and effort of reading descriptions of studies that are not relevant to you. Some firms allow you to subscribe to mailing lists so that you are informed as new studies open up.

The American Cancer Society’s Clinical Trials Matching Service

After reviewing the available matching services, the American Cancer Society chose to work with EmergingMed in an effort to provide a free, confidential, and reliable matching and referral service to patients looking for clinical trials. The American Cancer Society provides access to the EmergingMed system for our constituents through our Web site (click on “Find a Clinical Trial”) and through our Cancer Information Center’s toll-free number, 1-800-ACS-2345. ACS offers this service to help patients find high quality care in clinical trials most appropriate for their medical needs and personal preferences, while helping researchers develop more effective treatments for future patients.

The EmergingMed system starts with all the government-funded trials in the National Cancer Institute’s listing system, and then adds trials funded by a number of pharmaceutical and biotechnology firms. To our knowledge, this is the most comprehensive matching database of cancer clinical trials available anywhere. Some other services include a relatively small list of trials being conducted by a single company, or by a number of companies who are clients of the matching service. Other matching services are filled primarily with government-funded trials.

The business of most clinical trials matching firms is based on receiving a fee for listing studies or getting a “finder’s fee” from those running the studies when someone enrolls. Because of this, there may be some differences in the way they “rank” or present the studies to you. The clinical trials information provided by the American Cancer Society is not biased in any way by whether the trial is funded by the government or by pharmaceutical or biotechnology firms.

The clinical trials information provided by the American Cancer Society is updated continually, as is the contact information that enables patients to get in touch with the doctors and nurses at cancer centers conducting each of the trials.

For more information about the American Cancer Society’s clinical trials matching service, visit our Web site, (click on “Find a Clinical Trial”), or call our Cancer Information Center at 1-800-ACS-2345. For information about the EmergingMed database used by the American Cancer Society’s clinical trials matching service, visit

Other Clinical Trials Lists and Matching Services

The National Cancer Institute (NCI) sponsors the majority of government-funded
cancer clinical trials. The NCI maintains a list of active studies
(those currently enrolling patients), as well as some privately funded
studies, in the Physician Data Query (PDQ) database. You can access the
list via
their Web site at or by
calling 1-800-4-CANCER. You can search the list by the type and stage
of cancer, by the type of study (for example, treatment or prevention),
by geographic location.

The National Institutes of Health (NIH) maintains an even larger database of clinical trials at, but not all of these are cancer specific.

CenterWatch is a publishing and information services company that maintains a list of both industry-sponsored and government-funded clinical trials for cancer and other diseases.

Major cancer centers (and even some community hospitals and doctors’ offices) usually offer lists on their Web sites of the clinical trials being conducted there. You can find the major NCI-sponsored cancer centers and the Commission on Cancer-approved centers closest to you on the American Cancer Society Web site in the section called Find Treatment Centers.

Private companies, such as pharmaceutical or biotechnology firms, may list the studies they are sponsoring on their Web sites. Some of these firms also offer matching systems for the trials they sponsor. This can be helpful if you are interested in research on a particular experimental treatment and know the company developing it.

The Coalition of National Cancer Cooperative Groups (CNCCG) provides a system for matching patients with cancer studies being conducted at member institutions on their Web site, Their database includes most of the government-funded cancer clinical trials in the NCI and NIH lists, and some privately-funded studies as well.

How to Choose a Clinical Trials Matching Service

Because different services vary in the way they work, be sure you understand how the service you are looking at operates. Ask the following questions. Note that the answers do not necessarily mean that the service is not worth using:

  • Is there a fee for using the service?
  • Do I have to register to use the service?
  • Does the service keep my information confidential?
  • Where does the service get its list of clinical trials?
  • Does the service rank the studies in any particular order? Is this based on fees they are receiving?
  • Can I contact the service via the Internet or by telephone?

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How Do I Figure Out Which Study Is for Me?

Whether your doctor suggests a specific clinical trial or you use the available lists or matching services on the Web, how do you know which study makes sense for you?

At any one time, you are likely to be eligible for several studies. There may be obvious reasons for excluding some, such as those that are not being done near where you live. Understanding what each study involves will help you in making your decision.

The Study Protocol

The study protocol is the written plan for how a clinical trial is to be conducted. It is what is submitted to the FDA before a new treatment can be studied. A protocol contains the following information:

  • Why the study is being done (including the goals of the study)
  • Information about the treatment being tested, often including results of previous studies
  • The phase of the study and how many people will be enrolled
  • Who is eligible for the study
  • How the treatment is to be given
  • What tests people will have done during the study and how often
  • Other information that will be collected on participants

Actual study protocols can be 100 pages or more in length, and they can be very technical. Because these protocols are not written with patients in mind, making sense of their language is not always easy.

The clinical trials lists available on the Web use summaries of these protocols. Often, the most important parts for patients looking for studies are the eligibility criteria and any information available about the new treatment.

Eligibility Criteria (Inclusion Criteria)

Each clinical trial has certain conditions, or criteria, that patients must meet before they can enter the study. These are necessary to ensure that the study can answer the specific questions it was designed to answer. For cancer clinical trials, these criteria usually have to do with:

  • The type of cancer a person has
  • The stage (extent) of the cancer
  • Previous treatments a person must or must not have had
  • The length of time since a person last received treatment
  • Results of certain laboratory tests
  • The medicines a person is taking
  • Other medical conditions the person has
  • Any previous history of another cancer
  • A person’s activity level (also known as performance status)

Other factors, such as a person’s age and sex, may also be part of the criteria. There may be other conditions that are more specific to each study, as well.

Advertisements and lists may not contain all of a study’s eligibility criteria. If you’ve found a study you think you might qualify for, you can usually contact someone associated with the study to get a full list of the eligibility criteria.

I Think I’m Eligible. Now What?

Once you’ve found a study or studies that you think you’re eligible for, deciding if it’s the right one for you can still be tricky. And there may not be one best study for you. Again, learning as much as you can is key.

A good first step will be to talk with someone connected to the study. This could be the PI—the doctor in charge of the study—or a research coordinator. Research coordinators are usually nurses. Their job is to check to see if people meet eligibility criteria before entering a study. They also make sure that the study protocol is followed for each patient. Often they serve as a link between study patients and their doctors.

Both PIs and research coordinators should be able to answer any questions you have about the study. See the section “Should I Think About Taking Part in a Clinical Trial?” for a list of questions you should ask. Although they can give you answers about their particular clinical trial, they are not likely to be helpful in discussing other studies you may be considering. What’s more, they may be biased (even if unintentionally) toward their own study.

If you have access to the Internet, you can do some research on your own. Try to find out if the new treatment has been studied before or if it is being studied now in other diseases, as well as if any results are available. If this is difficult for you, have someone close to you help or do it for you. People with a medical background may have an easier time sorting through such information.

If you haven’t already, talk to your own doctor about studies you are looking at. Bring in whatever information you can, so that your doctor can help you judge what might be right for you. While no doctor is familiar with every clinical trial being conducted, yours can probably tell you whether the study is worth considering. This discussion can be time consuming, so you may need to make a special appointment to allow him or her enough time to look over the information you provide.

You may also want to get a second opinion from a doctor not connected to the studies you are considering. Doctors who are well known in their fields are usually up on the latest experimental treatments, and they may be able to point to ones that appear more promising.

Finally, talk to friends and family members you trust. While the decision is ultimately yours, their opinions may provide you with insight into things you had not considered.

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What About Cost? Will My Insurance Cover It?

This is a crucial question to ask before deciding to take part in a clinical trial. Recent studies have shown that costs of taking part in a clinical trial are not much more than the costs of treatment outside of a study. Still, insurance coverage can vary widely.

When insurers do cover costs related to clinical trials, it is usually only for tests, treatments, or doctor’s visits that would have been part of your treatment plan if you were not taking part in a study. In other words, they are not likely to pay for special tests or treatments you are getting solely because you’re in the study.

The study sponsor (whether it is the government or a pharmaceutical or biotechnology company) usually provides the new treatment at no cost and pays for special testing or extra doctor visits. Some sponsors may pay for more than this; for example, some may offer to compensate for travel time and mileage.

Private Insurers

In the past, insurers were sometimes reluctant to pay for any of the costs related to a clinical trial. Their concern was that they would be paying for treatments that had not been proven to be effective.

In recent years, many (but not all) major insurance providers have volunteered to cover some of the costs of clinical trials. However, they may limit which types of trials they will cover. They are more likely to pay for costs from phase II or III clinical trials, but they generally look at each request on a case-by-case basis.


As of March 19, 2000, Medicare began to cover the “routine” costs related to all government-sponsored phase II and III clinical trials.

Laws Regarding Clinical Trials Coverage

In recognizing the importance of clinical trials, many states have passed laws about insurance coverage for research studies. Several more are now considering legislation. A few states have worked out voluntary agreements with insurance companies to provide clinical trials coverage. The types of studies and exact coverage required by these laws vary from state to state - some cover all clinical trials, while others may cover only certain phases of clinical trials. For a list of states with clinical trials insurance laws, see our document “Clinical Trials: State Laws Regarding Insurance Coverage”.

The federal government may soon become involved as well. Bills have recently been introduced in both houses of Congress that, if passed, would require insurers to provide coverage for certain clinical trials. This would allow more people to participate.

What You Can Do

If possible, find out what your insurer will cover before you get involved in a clinical trial.

Find out if laws have been passed in your state that require coverage of routine costs of clinical trials. Then gather as much information as you can about the study and contact your provider to discuss coverage. Many providers may not be able to give you a simple “yes” or “no” answer up front, as many of them review claims on a case-by-case basis. You may, however, be able to find out if they’ve covered costs for trials similar to yours (or ones that studied the same treatment) in the past.

Have a summary of your study available, and, if possible, any results of previous studies of the treatment. You may need to ask your doctor or the study’s research coordinator for help in gathering this information. If necessary, your doctor may be able to further justify to your insurer as to why this study is appropriate for you.

Study sponsors are often eager to recruit eligible patients for their trials, and they may be willing to cover costs if your insurance does not. If needed, ask your doctor or the research coordinator to contact the study sponsor on your behalf.

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What Would Participating Involve for Me?

Having an idea of what you can expect from taking part in a study can help alleviate stress and make the study go more smoothly. The first thing you will need to do is give your informed consent to participate.

Informed Consent

Before you take part in any way in a research study, the people conducting the study are required to get your written, informed consent to participate. In the informed consent process, the researchers (doctors or nurses) will explain the details of the study to you and answer all of your questions and concerns.

You are then given a written consent form to sign. While consent forms are not all the same, they should include the following:

  • The reason for the study (what the researchers hope to find out)
  • Who is eligible to take part in the study
  • What is known about the new type of treatment
  • The possible risks and benefits of the new treatment (based on what is known so far)
  • Alternative treatments that may be an option for you
  • The design of the study (whether it is randomized, double blinded, etc.)
  • What/how many tests and doctor’s visits are involved
  • Who is responsible for the costs of the clinical trial (tests, doctor’s visits, etc.) and for the costs if you need additional care as a result of the clinical trial
  • A statement about protecting your identity
  • A statement about the voluntary nature of the study and your right to leave the study at any time without fear of compromised care
  • Contact information if you have further questions

Before you sign the consent form, ask questions. Be sure someone from the research team goes over the form with you in detail. Efforts are made to make consent forms as understandable as possible, but there still may be terms or ideas that are confusing to you. You may want to bring someone along with you to the meeting.

Be sure you understand what is involved and what is expected of you. You may want to explain what you heard back to your doctor or nurse to make sure you got it right. Recent surveys have shown that while most people are satisfied with the informed consent process, over half do not understand some of the main points on the consent form.

Finally, don’t be rushed into making a decision. Take the consent form home with you if needed. Get opinions from trusted family members and friends. If possible, get a second opinion from another doctor as well.

Participating in the Study

Once you’ve signed the consent form, you are ready to take part in the study. You will most likely need to have blood tests or imaging tests done before you start treatment (if you haven’t had them recently). A full history and physical exam are also usually required. The results are needed beforehand to confirm that you meet the eligibility criteria and to help ensure your safety.

As mentioned earlier, some studies may require you to stay in a hospital for a day or two to receive treatment. In other studies the participants are treated much the same way as other patients getting treatment outside of a clinical trial.

You may also have tests done more frequently, both to determine how well the treatment is going and to look out for your welfare. You will likely receive more attention as a study participant than you would otherwise. The doctors and nurses may examine you more often and will want to know if you experience any side effects (called “adverse events”) while getting treatment.

Because the possible complications may not fully be known, it is very important for you to let them know about anything out of the ordinary. They can then decide if what you are experiencing is related to the study and if the symptom needs to be treated or your therapy needs to be changed.

Your participation in the study may end for any number of reasons:

  • You complete treatment on the study
  • The treatment does not appear to be working for you
  • You experience serious side effects while in the study
  • The study itself is stopped early because the treatment either has proven to be effective or has proven to be too harmful in other participants
  • You decide to leave the study

Once out of the study, you may still be monitored for a time so that researchers can continue to get an idea of how you are doing.

Some studies allow you to continue to receive the new treatment even after the study ends. This is known as “open enrollment.” This option varies among clinical trials, so be sure to ask about it before you begin.

What If I Want to Leave the Study Early?

You will be told several times before you enter the study that your participation is always voluntary. This is an important point. You have the right to leave the study at any time, for any reason. Your doctor will still take care of you to the best of his or her ability.

You may be asked if the researchers can follow up with you from time to time to see how you are doing. This may provide them with important information and can also help ensure your safety, even after you leave the study.

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What If I’m Not Eligible for a Clinical Trial?

Unfortunately, some people may find that they are not eligible for clinical trials being conducted for a certain treatment, even if they believe the treatment may help them. Usually this happens because they do not meet the eligibility criteria outlined for the studies.

At times, however, there may be other ways to get access to treatments that are not yet FDA approved. These are usually referred to as “expanded access” or “compassionate use” programs. In recent years the FDA has expanded these programs to allow patients who urgently need these treatments to have access to them. But because of the amount of effort and paperwork involved, the process can at times be slow (weeks to months), and treatment manufacturers are not obligated to provide treatment.

Three such programs are described below. All require your informed consent, much the same as for any clinical trial.

Special Exception

A special exception allows a person who does not meet the eligibility criteria to still receive the treatment being studied if his or her doctor believes it could provide some benefit. It requires that the person have a serious condition for which there are no other treatment options. While not officially part of the study, the person is treated according to the study protocol (the same tests, doctor’s visits, follow up, etc.).

Your doctor must get in touch with the manufacturer to see if they are willing to supply the treatment. Your doctor would then request the special exemption, which requires filing the appropriate paperwork with the FDA. Both the FDA and the study’s IRB must approve the proposal.

Single Patient Use

Single patient use is similar to a special exception. It does not require that the specific study protocol be followed, but it would likely require that your doctor spell out in detail the proposed treatment plan.

Once again, your doctor would need to contact the manufacturer to see if the treatment could be obtained. He or she would then get approval from the IRB and the FDA before treatment would be allowed to begin.

Emergency Use

Emergency use is the use of an unapproved treatment for a person with a “life-threatening” or “severely debilitating” condition when there isn’t time to get approval from the IRB.

Your doctor would need to contact the manufacturer to see if the treatment is available and then file the needed paperwork with the FDA. While IRB approval is not needed before starting treatment, the IRB would have to be notified of the situation.

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Source: American Cancer Society

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