By participating in a clinical trial you play an active role in your own health care. You will have access to the latest treatments before they are widely available and most importantly, you’ll help with the advancement of drug development for diseases that affect many people.
It is important to understand the risks and benefits of participating. The results of each trial can differ and often differ from patient to patient. Not all trials result in good outcomes, but many do. Make sure you are aware of the benefits and potential side effects before you consent to participate.
The process for drug development is very complex. New drugs must go through several phases of clinical trials before the Food and Drug Administration (FDA) approve them for use with the general public.
- Phase I trials are the first studies to evaluate how a new therapy should be administered – how often, and in what dosage. The focus is to determine safety (drug dose, device safety, or other therapy’s safety) for the next phase of testing. Phase I trials usually treat a small group of (20-80) people in the test group.
- Phase II trials are given to a larger group of people (100-300), which provides preliminary information about how well the new therapy works, and generates more information about its safety and benefits.
- Phase III trials are given to an even larger group (1,000-3,000) people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the experimental drug or treatment to be used safely.
- Phase IV trials include the continuing evaluation that takes place after FDA approval, when the therapy is already available for general use.
The Scott & White Cancer Research Institute (CRI) and the Division of Research offer over 500 clinical trials for many different diseases.