The Impact Of Invisible Data: Analyzing Unreported Clinical Trials
Despite the scientific, social and ethical implications of withholding clinical trial data, which have been widely debated in the public arena, many studies remain unreported according to data from the AllTrials initiative and Trialtrove.
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US FDA will soon ramp-up enforcement of the clinical trial transparency provisions of Title VIII of the Food and Drug Administration Amendments Act of 2007, according to TrialScope Chief Strategy Officer Thomas Wicks. Those that fall foul of these new requirements will face penalties – and it looks like SMEs will be hardest hit.