The potential benefits of participating in a clinical trial may include the following:
- Access to promising new treatments often not available outside the clinical-trial setting
- Treatment that may be more effective than the standard approach
- Close monitoring, advice, care, and support by a research team of doctors and other health care professionals, such as a gastroenterologist, who understand your disease or condition
- The opportunity to be the first to benefit from a new method under study
- The chance to play an active role in your own health care and gain a greater understanding of your disease or condition
- The chance to help society by contributing to medical research. Even if you don’t directly benefit from the results of the clinical trial you take part in, the information gathered can help others and adds to scientific knowledge. People who take part in clinical trials are vital to the process of improving medical care.
The potential risks of participating in a clinical trial may include the following:
- The clinical trial may require more time than a non-clinical trial treatment such as more visits to the clinical trial site, more treatments, hospital stays, etc.
- There may be unpleasant, serious or life threatening side effects to experimental treatments.
You should discuss with your doctor and carefully consider the potential benefits and risks of participation in a clinical trial. If you qualify to participate in a clinical trial, the decision to participate is yours to make. A medical ethics committee oversees the clinical trial to ensure all participants are appropriately treated. If you are eligible and choose to participate in a clinical trial, an informed consent document will be presented to you. The informed consent document includes detailed information about the clinical trial, what you can expect as a participant and the potential benefits and risks associated with the clinical trial. If you are dissatisfied at any time during the conduct of a clinical trial, you are free to leave the clinical trial.
How is the Safety of Clinical Trial Participants 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.
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.
Source : Novartis®, NIH.