Possible Benefits For some, the benefits to enrolling in a clinical trial may be the chance to get state-of-the-are treatment and specialized medical attention— usually at no extra cost. Many trials also pay for time spent, travel costs, or other trial-related expenses.
For most people, participation in a clinical trial is a chance to try new therapies, learn more about a condition, and to have the satisfaction of contributing to science and helping researchers make progress.
Possible Risks The medicines being tested may not work. Also, side effects may be serious or unpleasant for some participants. A health professional is obligated by law to explain the possible risks and all known side effects during the informed consent process, and before you sign any documents or enroll.
Participants' Rights The U.S. Food and Drug Administration (FDA) has carefully written rules about what must be done to protect the safety and privacy of participants. According to federal regulation, every clinical trial must be approved and monitored by an Institutional Review Board (IRB). This independent committee of doctors, nurses, and others is charged with ensuring that the study is ethical and that the rights of participants are properly protected.
Informed Consent The very first activity for everyone considering participation in a clinical trial is reading and discussing information about the study, the specifics of the experimental treatment, and the procedures (including things like blood draws and MRIs) and methods used during the study (some may require patients to keep a diary, for example). An informed consent form (ICF) outlines all these important facts. You will be provided ample opportunity to read this form, digest it, and ask as many questions as you need. You can even take it home and 'sleep on it.' One better? You can also call us at any point for additional perspective if you like. Once you fully understand the terms of the trial, you will be asked to sign the informed consent form.
What is a Randomized Placebo-Controlled Clinical Trial? Depending on the study design, after discussing the study and signing the consent form, participants may be randomly assigned to the study's “control” group, meaning that they may receive a slightly different dose of the “test” treatment, a placebo (dummy drug or 'sugar pill'), or they may receive also receive the treatment that is already on the market and considered "standard therapy" for the condition.
The only catch is that as participants, we do NOT get to decide which group we are assigned to. That would muddy the results and create what's called "bias." But know that in many cases, studies don't use a placebo at all. When all the data are collected and analyzed, clear comparisons are made regarding what made the biggest difference in outcomes in the study group. Researchers compare results from the control group to the treatment group, and can then determine effectiveness from those results. This process makes participants invaluable research partners!
Am I allowed to quit a trial before I have completed all steps? You are entitled to withdraw from a study at any point without jeopardizing your future medical care. However, since enormous resources are required to perform studies, a potential participant must put a lot of thought into whether he or she wants to make the commitment.
How will trial researchers protect my confidentiality? Investigators will never use your name in any published documents nor can they give out information that would identify you to outside sources. Although the FDA and other agencies can access your medical records for inspection, your medical information cannot be used for any other purpose.
More Smart Questions to Ask
Does this study include a placebo? If so, what exactly is it?
Will participating affect my day-to-day life in any way? How?
How many visits are there in total, and how flexible is the scheduling of my study visits?
What is the study compensation to me? How am I paid?
Empowered participants have the best experience, and we can help prepare you for your research adventure!