When you see that a new drug got the FDAÃ¢â‚¬â„¢s stamp of approval, you might assume that it went through years of clinical trials with thousands of participants. But thatÃ¢â‚¬â„¢s not always the case. The types of trials used to approve new drugs can actually vary greatly, according to a recent study published in The Journal of the American Medical Association.
Researchers looked at FDA trials for new drugs conducted between 2005 and 2012. They found that more than one third of the drugs were approved after a single trial, and many other trials seemed less than thorough (small sample size, short duration, etc.).
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While the FDA requires the same basic standards for all clinical trials, there is some flexibility in how trials can meet these requirements, depending on the medication and the disease itÃ¢â‚¬â„¢s treating. Ã¢â‚¬Å“Some drugs may be tested in clinical trials that enroll hundreds of participants, while othersÃ¢â‚¬”particularly those seeking to treat rare diseases [for which the sample of people who could even participate in trials is much lower]Ã¢â‚¬”may be tested in trials that enroll only a handful of participants,Ã¢â‚¬Â says Sandy Walsh, from the FDA Office of Media Affairs.
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So what should you do if youÃ¢â‚¬â„¢re prescribed a new med and youÃ¢â‚¬â„¢re curious about the clinical trials it had to undergo to be approved? Take a look at the written materials that comes with your prescription for information on the trials and frequently reported adverse reactions, says Walsh (You can also find it online here). And if youÃ¢â‚¬â„¢re still unsure, talk to your doctor or pharmacist for more details.
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