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The Process of Clinical Trials
A clinical trial is a research study designed to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Estimates on the number of research studies range from about 5,000 to 7,000 each year, many at multiple sites.
A protocol describes what kinds of people may participate in the trial; the schedule of tests, procedures, medications and dosages; and the length of the study.
Clinical trials of experimental drugs proceed through four phases. In Phase I clinical trials, researchers test a new drug or treatment for safety in a small group of people (20-80). A larger group gets the drug or treatment in Phase II.
In Phase III studies, the drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow the drug or treatment to be used safely. Phase IV studies are done after the drug or treatment has been marketed.
Every clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates and others that ensure that a clinical trial is ethical and the rights of study participants are protected.
Informed consent is the process of learning the key facts about a clinical trial before one decides whether to participate.
All clinical trials have guidelines about who can get into the program. Guidelines are based on such factors as age, type of disease, medical history and current medical condition.
- The Hartford Courant |
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