Questions to Ask Before Participating in a Clinical Trial

 

The following are some questions to ask the research team when thinking about a clinical trial. Write down any questions you might have and bring your list with you when you first meet with the research team.

Older man asking a researcher questions about clinical trials

  • What treatment or tests will I have? Will they hurt?
  • What are the chances I will get the experimental treatment?
  • What are the possible risks, side effects, and benefits of the study treatment compared to my current treatment?
  • How will I know if the treatment is working?
  • How will you protect my health while I am in the study?
  • What happens if my health problem gets worse during the study?
  • How will the study affect my everyday life?
  • How long will the clinical trial last?
  • Where will the study take place? Will I have to stay in the hospital?
  • Will you provide a way for me to get to the study site if I need it?
  • Will being in the study cost me anything? If so, will I be reimbursed? Will my insurance cover my costs?
  • Can I take my regular medicines while in the trial?
  • Who will be in charge of my care while I am in the study? Will I be able to see my own doctor?
  • Will you follow up on my health after the end of the study?
  • Will you tell me the results of the study?
  • Whom do I call if I have more questions?
  • How will you keep my doctor informed about my participation in the trial?
  • Does the study compare standard and experimental treatments?
  • If I withdraw, will this affect my normal care?
  • What are the chances that I will receive a placebo?
  • What steps ensure my privacy?

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Clinical Trials: Benefits, Risks, and Safety

 

You may ask yourself, “Why should I try something that researchers are not sure will work?” That is a good question. Being part of a clinical trial may have risks, but it may also have benefits.Older couple listening about the benefits, risks, and safety protections of clinical trials

Benefits of a Clinical Trial

  • You may get a new treatment for a disease before it is available to everyone.
  • You play a more active role in your own health care.
  • Researchers may provide you with medical care and more frequent health check-ups as part of your treatment.
  • You may have the chance to help others get a better treatment for their health problems in the future.
  • You may be able to get information about support groups and resources.

Risks of a Clinical Trial

  • The new treatment may cause serious side effects.
  • The new treatment may not work or it may not be better than the standard treatment.
  • You may NOT be part of the treatment group (or experimental group) that gets the new treatment—for example, a new drug or device. Instead, you may be part of the control group, which means you get the standard treatment or a no-treatment placebo.
  • The clinical trial could inconvenience you. For example, medical appointments could take a lot of time or you might be required to stay overnight or a few days in the hospital.

How Will My Safety Be Protected?

This is a very important question. The history of clinical research is not perfect. Based on many years of experience and learning, Congress has passed laws to protect study participants. Today, every clinical investigator is required to monitor and make sure that every participant is safe. These safeguards are an essential part of the research. Research abuses like the Tuskegee Syphilis Experiment, which began in 1932, before safeguards were in place, will NOT happen again.

Researchers are required to follow strict rules to make sure that participants are safe. These rules are enforced by the Federal Government. Each clinical trial also follows a careful study plan or protocol that describes what the researchers will do. The principal investigator, or head researcher, is responsible for making sure that the protocol is followed.

An Institutional Review Board, or IRB, at each study site must approve every clinical trial in the United States. The IRB is made up of doctors, scientists, and lay people, like yourself, who are dedicated to making sure that the study participants are not exposed to unnecessary risks. The people on the IRB regularly review the study and its results. They make sure that risks (or potential harm) to participants are as low as possible.

Along with the IRB, many clinical trials are closely supervised by a Data and Safety Monitoring Committee. The Committee is made up of experts in your condition who periodically look at the results of the study as it is in progress. If they find that the experimental treatment is not working or is harming participants, they will stop the trial right away.

The informed consent process also helps protect participants. Before joining a clinical trial, you will be told what to expect as a participant and all the things that might happen. For example, someone from the research team will explain possible side effects or other risks of the treatment. As part of the informed consent process, you will have a chance to ask questions about the trial. The clinical trial coordinator will be happy to answer your questions.

After getting all this information, you can think about whether or not you want to participate. If you decide to join the trial, you will be given an informed consent form to sign. By signing the form, you show that you have been told all the details and want to be part of the study. The informed consent form is NOT a contract. You can leave the trial at any time and for any reason without being judged or put in a difficult position regarding your medical care. Researchers must keep health and personal information private.

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