Are Clinical Trials Safe for Participants?
Like any medical procedure, all clinical trials come with risks. The safety and efficacy of a new drug is not fully known when the trial starts. Each person must come to their own conclusion as they weigh the potential benefits of participation against any risks.
There are several ways researchers, doctors, and trial sponsors can explain risk in clinical trials.
- All of the risks and requirements associated with a trial must be presented, understood, and accepted by all participants prior to the start of the study.
- Each trial is carefully monitored by an ethics committee (also called an Institutional Review Board, or IRB) as well as by regulatory agencies (like the FDA). This is to ensure patient safety stays the top priority.
- If any participant shows a decline in health, “rescue” procedures may be in place to ensure appropriate therapies are provided.
Participant Free Will
- Participants can withdraw from the study at any time, even after providing their informed consent. Unpleasant side effects, ineffective treatment are two reasons someone may choose to withdraw.
So that, in four nutshells, is what clinical trials are about.
Patients and families affected by rare diseases like acromegaly know all too well the challenges of managing symptoms and maintaining a good quality of life when treatment options are scarce, inconvenient, and/or painful. For these patients and countless others, clinical trials are key to the discovery of new treatments.
If you’re considering participating in a clinical trial, your doctor may be able to suggest an appropriate study for your condition. We also encourage you to explore the resources listed to learn more.