Clinical trials are the vessel to developing clinical research programs that drive the advancement of medicine. The core objective of a clinical trial is to find new and improved methods of treating, preventing, screening for, and diagnosing different health concerns. Human volunteers, also known as participants, work with doctors and researchers to evaluate new medical treatments, drugs, devices, novel surgical procedures, diagnostic tests, or gene therapies. This makes it possible to apply the latest scientific and technological advances to patient care.

Clinical trials are conducted in phases. Each new phase of a clinical trial builds on the information collected from the previous stage. Participants may be eligible for clinical trials in different phases, depending on their overall condition. Most participants take part in phase III and phase IV trials.

Phase I: This is the beginning of a new research treatment that is given to a small number of participants and emphasizes safety.

Phase II: This phase determines the effect of a research treatment on the particular disease or condition being evaluated.

Phase III: This phase compares the new treatment with the standard treatment and studies the different populations and different dosages.

Phase IV: This phase applies the new treatment to the general patient (after FDA approval for marketing).

Each clinical trial will vary on who is deemed eligible to participate. Each clinical trial is designed to meet specific research criteria and will enroll participants with certain conditions or symptoms. Some clinical trials will enroll people who have a been diagnosed with a specific disease or condition. Others may enroll healthy participants to test new approaches to prevention, diagnosis, or screening.

All participants will face a new frenzy of medical terms and procedures. Fears and myths about being experimented on are common concerns for participants who are thinking about joining a clinical trial. While there will always be fears of the unknown, making sure you understand the procedures and what is being asked of you prior to joining a clinical trial will help alleviate some anxiety.

People participate in clinical trials for a variety of reasons. Some may want to play an active role in their personal health by gaining access to cutting-edge research treatments. Some may want to help others by contributing to the advancement of medical research. Others may be seeking decreased costs for treatment of a disease, as many of the tests and doctor visits that are directly related to the clinical trial are paid for by the party sponsoring the study.

Regardless of the reason why an individual chooses to take part, clinical trials offer hope for many people and an opportunity to assist researchers find better, future treatments.

• National Institutes of Health
• U.S. Food and Drug Administration
• Clinicaltrials.gov