A victory for clinical trial transparency, with a catch
A decade’s worth of clinical data on approved drugs and devices could finally be made public thanks to new federal rules, but it’s unclear just how much pressure the government will put on industry to comply.
As STAT’s Lev Facher reports, thanks to a court ruling and federal action, the government has instructed clinical trial sponsors to submit data to ClinicalTrials.gov for studies conducted between 2007 and 2017 “as soon as possible.” That’s a victory for transparency advocates, who for years have fought to recover the decade-long gap in publicly available clinical trial data.
But no one knows what the government might do to compel companies to act. The FDA and NIH have the legal right to levy penalties and withhold grant funds from companies that don’t comply with transparency rules, but neither agency has ever done so.
Read more.
As STAT’s Lev Facher reports, thanks to a court ruling and federal action, the government has instructed clinical trial sponsors to submit data to ClinicalTrials.gov for studies conducted between 2007 and 2017 “as soon as possible.” That’s a victory for transparency advocates, who for years have fought to recover the decade-long gap in publicly available clinical trial data.
But no one knows what the government might do to compel companies to act. The FDA and NIH have the legal right to levy penalties and withhold grant funds from companies that don’t comply with transparency rules, but neither agency has ever done so.
Read more.
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