What are the Benefits of a Clinical Trial?
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. Past clinical trial history has led many to hesitate to sign up for research. However, today there are strict rules in place to keep your health and privacy safe.
| 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 better treatment for their health problems in the future. |
| You may be able to get information about support groups and resources |
| Compensation is available to all volunteers for each study |
Qualified participants may receive compensation for their time, travel and study related participation, with the amount varying by study.
What are the patient benefits and how is this regulated?
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. Researchers are required to follow strict rules to ensure patient safety. 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.
Compensation is available to all volunteers for each study after each visit. Participating in a clinical trial gives individuals access to innovative treatments and expert medical care while contributing to advancements that may improve future healthcare for others. Clinical trials can offer close monitoring by healthcare professionals, access to new therapies before they are widely available, and the opportunity to play an important role in advancing medical research and improving lives.
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 laypeople, 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. Participants safety is our highest priority. If ongoing monitoring shows that the study treatment is not effective or may pose a risk to participants, they will be removed from the study
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, your decision is an option and will not be coerced to volunteer. 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.