About Clinical Trials

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

The potential benefits of a clinical trial depend on the treatment being studied. There may be no benefits for participating in a clinical trial. Potential general benefits of taking part in these research studies include being seen and carefully monitored by experts in treating and studying your condition. You may receive 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.

There may be unpleasant, serious or life-threatening 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 commercially available. Participation in a trial may require extra paperwork, more treatments 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.

Clinical trials need to be approved before they start, and there are several layers of review 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 to study an investigational new treatment in the U.S. must submit the research plan, called a “protocol,” to the U.S. Food and Drug Administration (FDA) before a trial can start. In addition, if the FDA determines that a trial in progress isn’t going according to the protocol, the FDA has the authority to stop the trial.
• 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.

An arm refers to a group or subgroup of participants in a clinical trial that receives specific treatment according to the study protocol. Clinical trials can have just one arm or multiple arms. 

Before starting a trial, you will be 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.

Generally, clinical trials are free to participants. Research costs, which include costs that are not considered part of your standard of care may be paid for by the trial sponsor. Costs associated with travel may also be paid for. Talk to your research team to make sure you understand who pays for what before joining a 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.