To ensure a new drug works properly after marketing approval is granted, the Food and Drug Administration regularly requires a drug company to run a so-called post-marketing study. But a new analysis found a troubling lack of timely follow-through as well as basic information.
Specifically, one in four studies was never publicly disseminated. Meanwhile, there was often little information about post-marketing requirements — the median description was just 44 words — and some were difficult to categorize. There was also a lack of up-to-date information on the progress of about one-third of these study requirements.
Moreover, among required clinical studies that either reported results or were published, only two-thirds reported results publicly after scheduled deadlines, potentially limiting their usefulness to clinical practice, according to the analysis, which was published recently in BMJ.
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