Clinical trials are scientific research studies that examine different aspects of a disease or medical condition or evaluate new drugs and other treatments. By participating in a clinical trial, you can get free access to new therapies not yet available to others. However, you also take any risks associated with an unproven treatment.
All clinical trials have to meet guidelines outlined by both the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA). They also must meet the specific criteria of the institution that sponsors the research. A governing body known as an institutional review board (IRB) oversees the study design and protocols to ensure it meets specific ethical, clinical, and safety standards.
Clinical trials of new drugs fall into four different “phase” categories. Phase 1 studies are initial, small-scale trials that help establish a safe dose and determine side effects. Phase 2 uses a larger study population at the dose established in phase 1 to determine the efficacy of the drug, and phase 3 studies compare the new drug with existing treatments for the same condition or illness and monitor for side effects.
Finally, phase 4 trials are performed after the product is approved and introduced to the marketplace to gather “postmarket” data on its long-term safety and efficacy.
It's important to note that when you agree to participate in a clinical trial, you may not necessarily receive the treatment that the study is evaluating. Depending on the design of the study, you may be chosen to be part of a control group (members of which do not receive the therapy being tested in order to serve as a baseline for comparison), or you may receive a placebo (an inactive substance that is sometimes administered to half of the study group to measure the effectiveness of the treatment against a control).
Learning all of the potential ins and outs of a clinical trial is part of giving informed consent on the study. Because the treatments examined in clinical trials are still experimental, informed consent is an important aspect of meeting the ethical guidelines of scientific study.
If you're interested in participating in a clinical trial, your first step is to check and see what is available. The government website has a database of NIH-sponsored trials. If you live near a research institution or university, you can also check on available clinical trials there. Eligibility requirements will vary with each study.