Clinical trials are research studies in which participants volunteer to be treated with an investigational drug, device, or treatment method after being fully informed of the study, including the potential risks and benefits. Clinical research studies (sometimes called trials or protocols) are a way to develop new treatments, medications, or devices for diseases and conditions. There are strict rules for conducting and participating in clinical trials, which are monitored by the U.S. Food and Drug Administration at the national level and by an Institutional Review Board (IRB) at the local level.
For some patients, a clinical trial may be the best treatment option available, despite the uncertainty of the outcome. You may be one of the first participants involved in potentially ground-breaking research that can have a profound impact on the field of medicine! Others volunteer for clinical trials because they know that these studies make progress in treating a specific disease, for compensation, or for the individual care and attention they receive. Even if patients do not benefit directly, their participation and the information learned may benefit future patients. This helps some people feel that they are making a difference.
Each clinical trial has its own set of criteria to determine who can participate. They are based on study specifics, such as having a particular disease or condition, previous treatment history or length of time since diagnosis, other medical history, age, etc. The clinical team will determine if you fit the criteria for the study. And as a patient, you must be able to make an informed decision and consent to participate in the research study.
No two studies are compensated in the same way. Some studies will offer the study drug for free, study-related medical visits without cost to you, and/or a modest financial stipend when you reach certain milestones in the research. The clinical team will review the compensation with you if you consider participating in a clinical trial.
You are entitled to certain rights as a clinical trial participant. Prior to enrolling in any clinical trial, it is important to understand your patient rights before and during the clinical trial process:
Prior to Enrollment: Your Patient Rights
After Enrollment: Your Patient Rights
With any clinical trial, there are potential risks and benefits to consider before participating. For example, a clinical trial may require more time than standard treatment, such as more visits to the clinical trial site, or more medical tests. In addition, there may be unpleasant, serious or life threatening side effects to experimental treatments. It may be determined that the treatment drug or method was not more effective than standard treatment.
On the other hand, a participant has access to promising new treatments often not available outside the clinical trial setting. It is possible that the treatment may be more effective than the standard approach. You’ll receive close monitoring, advice, care, and support by a research team of doctors, nurses, and other healthcare professionals who understand your disease or condition. You have the opportunity to be among the first to benefit from a new drug or method under study.
More importantly, you have the chance to play an active role in your own healthcare and gain a greater understanding of your disease or condition. You also have 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.