Feds want more trial results made public

The Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) are proposing new rules that would greatly expand the number of clinical trials required to publicize their results, a move that could change how CROs handle data. Under the new rules, the makers of unapproved drugs and devices would have to post summaries of study results on ClinicalTrials.gov, the government's public portal, within a year of trial conclusion. The proposed changes would also streamline the rules for just who is required to submit trial information; expand the amount of information that must be disclosed shortly after study startup; and force sponsors to update their ClinicalTrials.gov entries more regularly. The change would impact how CROs, which do more and more of the industry's heavy lifting, deal with results during and after trials. HHS and NIH are soliciting feedback on the proposal from industry and academia through Regulations.gov. More

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