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The FDA Amendments Act requires that many clinical trials (e.g., prospective clinical studies of health outcomes, controlled interventional studies in humans, trials involving drugs or devices) be registered and their results be posted on ClinicalTrials.gov. In this analysis, investigators determined how frequently results of registered large randomized trials go unpublished in the medical literature or remain unreported at ClinicalTrials.gov.
Investigators analyzed 585 trials (with 1 million planned or actual study participants) that were listed as no longer recruiting, completed, or terminated. Literature review and contact with trial investigators identified at least one publication containing trial results for 414 studies (71%). The 171 …