About Clinical Trials

Thousands of people take part in clinical trials every year to help advance new treatments that have the potential to improve people’s lives.

New therapies are developed through research studies, or clinical trials. Patient volunteers and their family members are essential partners in our clinical trials, and we are grateful for their participation, which may lead to the availability of new treatment options for people living with cancer and autoimmune diseases.

What is a clinical trial?

A clinical trial is a research study in which people volunteer to test potential new treatments. Doctors use clinical trials to learn whether new potential treatments are safe and work for people before they are offered to the general public. All proposed new treatments must go through clinical trials before they can be approved by the U.S. Food and Drug Administration (FDA).

What are the benefits of joining a clinical trial?

The specific benefits of a clinical trial depend on the treatment being studied, but there are general benefits to taking part in these research studies. First, you will be seen and carefully monitored by experts in treating and studying your condition. You may get access to a new investigational treatment or test that you would not otherwise be able to have. Also, by participating in a trial, you will contribute to general scientific knowledge about your condition, which may help other people in the future. However, we cannot be certain that the clinical trial in which you participate will benefit your health, or successfully treat or cure your condition.

What are the risks of joining a clinical trial?

As with any test or treatment, there may be side effects. Also, because the test or treatment being studied is new, there is a chance that it may not work as well as or better than one already in use. Participation in a trial may require extra paperwork or more trips to the doctor or hospital. And in some cases, participation in a trial may disqualify you from receiving other new therapies while participating in the trial.

Who oversees a clinical trial?

Clinical trials need to be approved before they start, and there are several layers of safeguards to protect the people who participate in them:

  • The principal investigator is the physician responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the principal investigator is the responsible leader of the team.
  • A sponsor is an individual, company, institution or organization that takes responsibility for the initiation, management and/or financing of a trial. Any sponsor seeking approval for a new treatment in the U.S. must submit the research plan, called a “protocol,” to the Food and Drug Administration (FDA) before a trial can start. In addition, if the FDA feels a trial in progress isn’t going according to the protocol, the FDA has the authority to stop the trial. The FDA has the final say about whether a new treatment can be given to patients once trials are completed.
  • An IRB (Institutional Review Board) is a panel of experts independent from the study sponsor and principal investigator that reviews the protocol before a trial starts to make sure it is acceptable on medical, ethical and legal grounds. IRBs make sure that patients’ rights and welfare will be protected in the trial. The IRB reviews a trial’s progress regularly, at least every year.

What are the phases of clinical trials?

There are several stages, or phases, of clinical trials. Each phase is designed to answer certain questions and build on the knowledge from the previous phase.

  • Phase 1: “Is the treatment safe?”
    Phase 1 studies are usually the first studies conducted with people. They typically involve a small number of participants. At this phase, researchers are looking at what the drug does to the body and how the body reacts to the drug in order to find the highest dose that can be given without serious side effects.
  • Phase 2: “Does the treatment work?”
    If a new treatment is found to be safe in Phase 1 trials, it moves on to Phase 2. Phase 2 trials usually involve a larger group of participants. Researchers are watching for responses to the treatment and will also keep looking for any side effects.
  • Phase 3: “Is the treatment better than what is already available?”
    Phase 3 studies compare a new treatment to the current standard treatment, if there is one, for a condition. Most Phase 3 trials have a large number of patients and last longer than Phase 1 and 2 studies. Generally, after Phase 3, a sponsor can submit the results to the FDA and request that the drug be approved for use.

What is informed consent?

Before starting a trial, you will be fully informed about the potential risks and benefits of participating in the trial. If you understand what is involved in the trial, you will be asked if you agree to participate. This process is called informed consent. During this process, the investigator must explain all the details of the trial, including the potential risks, and answer any questions you have. Then, you will sign a written consent form that typically includes explanations of the trial’s purpose and design, your obligations during the trial, the risks and benefits, eligibility criteria, privacy protections, coverage of costs and other care options. Consent forms can be complicated and sometimes confusing, so take your time and ask as many questions as you need in order to fully understand what is involved and expected of you.

Will it cost me anything to participate in a trial?

Generally, clinical trials are free to participate in. Research costs, which may include travel, are often paid for by the trial sponsor. Talk to your research team to make sure you understand who pays for what before joining a trial.

Can I drop out of a clinical trial?

Yes. Your participation is voluntary, and you can withdraw from a clinical trial at any time for any reason. During the trial, if the sponsor or investigator learns new information that might affect your decision to stay in the trial, they will inform you of those changes so you can decide whether to stay in the trial or withdraw.

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