Participating in Clinical Trials
Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect or treat disease. However, before you participate in a clinical trial, you may want to read this article and ask some of the questions I am recommending.
People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also take part to help others, but also to possibly receive the newest treatments and additional care and attention that often accompanies participation in a clinical trial.
Clinical research is conducted according to a plan known as a protocol. The protocol is carefully designed to ensure safety to the participants. A protocol describes the following:
- Who is eligible to participate in the trial
- Details about tests, procedures, medications and dosages
- The length of the study and what information will be gathered
Most, but not all, clinical trials in the United States are approved and monitored by an Institutional Review Board (IRB). An IRB is an independent committee that consists of physicians, statisticians and members of the community who ensure that clinical trials are ethical and that the rights of participants are protected.
Participation in clinical research demands that the research team explain all of the details of the study. The informed consent describes the purpose, duration, required procedures and who to contact for further information should any questions arise at any time during the study period. The informed consent must also explain the risks and potential benefits of participation in the study. Participants are free to withdraw from the study completely or to refuse particular treatments or tests at any time.
Typically, clinical trials compare a new product or therapy with another that already exists, to determine if the new one is as successful as, or better than, the existing one. In some studies, participants may be assigned to receive a placebo or an inactive product that resembles the test product, but without having any treatment value. You will always be told if placebos will be used in the study before you enter a trial but will not know if you are receiving the active drug or the sugar pill\placebo. When placebos are used, members of the research team are not told which patients are getting which medication, so that their observations will not be biased.
If you are offered a clinical trial, you might consider asking these are questions:
- What is the purpose of the study?
- Why do researchers think the approach may be effective?
- Who will fund the study?
- Who has reviewed and approved the study?
- How are study results and safety of participants being checked?
- How long will the study last?
- What will my responsibilities be if I participate?
- Will I be compensated for participation in the study? (Usually not, but they will pay travel expenses, parking and meals that you pay for while involved in the study.)
Bottom Line: Advances in medicine have reached new heights partly because of clinical research. A well-conceived study that ensures your safety but answers questions about diagnosis, evaluations and treatments have made it possible to improve the care that we can receive. I highly recommend participating in clinical research, if you have the time and the desire to improve the health care of our community.
For more information, go to Cancer.gov and FDA.gov.
Dr. Neil Baum is a physician on the clinical faculty at Tulane Medical School. He can be reached at (504) 891-8454 or through his website: www.neilbaum.com