A clinical trial is a carefully conducted investigation, monitored by the FDA, to test new treatments and drug therapies. Drug trials fall into three categories: Phase I, Phase II, and Phase III trials.
Usually, Phase I trials are primarily safety studies on promising medications that have passed the hurdles in animal safety studies specified by the FDA. These studies test the safety of medications in humans, and often healthy subjects.
Phase II studies are generally dose-finding studies to see which doses of the medication being tested seem to work best, with the least toxicity.
Phase III studies generally compare a safe medication, in what is believed to be an effective dose, to another drug or placebo.
Only after passing all these Phases can a drug be considered for approval by the FDA. There are variations of these Phases. A new type of trial design, called Adaptive Trial Design, sets up goals for safety and success ahead of time, and monitors safety and effectiveness continually during the trial. Thus, the study can be changed during the trial. Generally, this type of trial, if it can be done, is much less expensive, much shorter, and is the trial design of the future.
But however the FDA approval process occurs, to take a drug through the FDA approval process costs hundreds of millions of dollars. This is in contrast to the FDA device approval process, which is generally a much shorter, and less exacting, process. The FDA approval of devices has come under considerable fire recently.
Why should you participate in a clinical trial?
The short answer is potentially to improve your own health, and the health of others. Trials are carried out with Good Clinical Practice and under the guidelines for protection of human subjects agreed to internationally. They must be approved by an Institutional Review Board, that guarantees protection of patient rights and ensures they are enrolled in a trial only after informed consent is obtained. Patients may leave the trial at any time for any reason even after enrolling in a study. There is no obligation to continue the study.
Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future (Information from National Institutes of Health).
What are the benefits and risks of participating in a clinical trial?
- There are both benefits and risks associated with clinical trials. By participating in a clinical trial, you may benefit by:
- gaining access to new treatments that are not yet available to the public
- obtaining expert medical care at a leading health care facility
- playing an active role in your own health care
- helping others by contributing to medical research
- Clinical trials may also have risks:
- there may be unpleasant, serious or even life-threatening side effects from treatment, though the chances of these are markedly decreased by the Trial process
- treatment may not be effective for some individuals
- the trial may require a lot of travel time
- health insurance may not cover all study costs
(Information from ClinicalTrials.gov).