Clinical trials: the basics

Clinical trials are key to moving medicine forward as they look at new ways to prevent, detect or treat disease, in the form of new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. The goal of clinical trials is to determine if a new test or treatment or a novel way to use an existing treatment works and is safe.

Healthy volunteers and people with illnesses participate in clinical trials; both are essential. While healthy participants help define the limits of ‘normal’, acting as controls for patient groups, patient volunteers allow researchers to better understand, diagnose, treat or cure the disease or condition they have.

Both healthy and patient volunteers can benefit from participating in clinical trials. While healthy volunteers generally decide to take part simply to help others by moving science forward, patient volunteers have the added benefits of gaining access to new research treatments before they are widely available and receiving regular and careful medical care from clinical trial staff.

Of course, there are also risks involved and participants need to be aware that taking part in a clinical trial can be a major commitment. For these reasons, participants are asked to sign a detailed informed consent document before agreeing to take part, and to carefully consider the possible benefits and risks. Ethical guidelines are also in place and all clinical trials in the US are approved and monitored by an external review board and in Europe by an ethics committee.

Ultimately, it is only through clinical research – of which clinical trials are a crucial part – that the scientific community can gain insights into and answers about the safety and effectiveness of new drugs and therapies. And it is only through the participation of both healthy and patient volunteers that clinical trials can take place. If we want to find cures for Alzheimer’s Disease and cancer in the future, or, in the nearer term, answers to key questions about these conditions, clinical trial participation of volunteers is absolutely essential.

For more detailed information about clinical trials and what to think about if you want to participate, visit the NIH website.