Clinical trials are research studies in which people help find new
ways to improve health and health care. Many of the cancer treatments in use today are
based on the results of past clinical trials.
Clinical trials are conducted in an orderly, carefully designed manner. After laboratory
and animal research is complete, several phases in humans help to answers questions such as:
- Is the drug, device, or procedure safe?
- Is it effective?
- What is the best dose?
Phases of clinical trials:
- Preclinical Phase: Before a new therapy can be used in patients research must be
conducted in a laboratory. This phase can take several years.
- Phase 1: In this initial phase, researchers study a new drug or treatment in a small group of people (often healthy volunteers). The focus in this early phase is safety. Investigators attempt to determine a safe dose for new drugs, effectiveness, and side effects.
- Phase 2: In this phase, investigators study the safety and effectiveness of the drug or treatment in a larger group of people. In this phase, the subjects are often people with the disease that the drug is designed to treat.
- Phase 3: In a Phase 3 study, the number of subjects is expanded to several hundred to several thousand subjects and often takes several years to complete. The goal of this phase is to provide the pharmaceutical company and the Federal Drug Administration (FDA) with a more complete understanding of all aspects of the drug-effectiveness, appropriate dose, and side effects. Phase 3 trials usually involve several centers and participants are generally a population for whom the drug or device is eventually intended.
- Phase 4: Phase 4 trials are conducted following introduction of the drug or device to market and provide additional information regarding use, benefits, effectiveness compared to treatments on the market, side effects not previously identified and other factors.
Participation in a clinical trial:
Clinical trials have guidelines that define who is eligible to participate. Participation in
clinical trials is voluntary. It is your choice to accept of decline. Participation may give you
access to new treatments before they are widely available or may allow you to benefit others by
allowing you to contribute to medical research. On the other hand, if you chose to decline to
participate in a clinical trial, it will in no way affect your care.
