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In 1999 and 2000, the U.S. Food and Drug Administration (FDA) approved 73 new medications, including new drugs for HIV, cancer, heart attacks and Alzheimer's disease.
Clinical trials may study new drugs, new uses or doses of previously approved drugs, devices or medical procedures.
To find out about clinical trials that are currently recruiting for your condition, ask your health care professional, contact a patient advocacy group and check out http://www.clinicaltrials.gov.
Under new guidelines issued in 2000, Medicare now covers many costs associated with participation in clinical trials.
Clinical trials of new drugs must be approved by the FDA and by an oversight committee-the Institutional Review Board-at each trial site.
If you participate in a clinical trial, you may have more doctor visits and tests than you would if you were not taking part of a study. That's because the research team needs to gather detailed data on the progress of your treatment.
A former director of the National Cancer Institute said that if only 10 percent of cancer patients participated in trials, it could slash the amount of time it takes to complete most efficacy trials from three to five years to just one year.
Clinical trials are conducted in four stages: Phase I, II, III and IV; Phase III trials are the largest and provide the best data on effectiveness and safety among the general population.
From 1977 to 1993, the FDA forbade early-stage testing of most medications on women of childbearing potential for fear of causing birth defects. (The ban was in place regardless of whether the woman planned to bear children.) Now, thanks to years of pressure by women's advocacy groups citing the need for gender specific information about drugs and diseases, women are recruited for trials, even if they are of childbearing age, but are informed of the potential risks of untested medication on fertility- and pregnancy- related issues (if any).
When a manufacturer believes a treatment may have exceptional promise, the FDA can issue what is called fast track or "priority review" status. If the treatment survives this accelerated scrutiny, it can be brought to market-and benefit patients-much sooner.
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