Federal regulators are proposing a rule that would require makers of drugs and medical devices to publicize the results of thousands of clinical trials, regardless of whether they succeed, part of a global move toward transparency in R&D.
The proposal, developed by the Department of Health and Human Services and the National Institutes of Health (NIH), would require the makers of unapproved drugs and devices to post summaries of study results on ClinicalTrials.gov, the government's public portal, within a year of trial conclusion. As it stands, sponsors are required to disclose results only on studies of approved products, which account for about 15,000 of the roughly 178,000 trials posted on the site, according to NIH.
The new rules, if adopted, would generally exclude Phase I and feasibility trials, NIH said, and they wouldn't alter the trial-design requirements needed to win FDA approval. Instead, they would greatly expand the public pool of clinical results, preventing unnecessary duplication, weeding out unsafe or ineffective products, and informing future research, according to NIH.
|NIH Director Francis Collins|
"Medical advances would not be possible without participants in clinical trials," Director Francis Collins said in a statement. "We owe it to every participant and the public at large to support the maximal use of this knowledge for the greatest benefit to human health. This important commitment from researchers to research participants must always be upheld."
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.
HHS and NIH are soliciting feedback on the proposal from industry and academia through Regulations.gov, opening up a 90-day window for discussion before making a final decision on the new rules.
Meanwhile, some of the world's largest drug developers have capitulated to the prodding of global regulators, making varying amounts of data available through ClinicalStudyDataRequest.com. Some, like Sanofi ($SNY) and Bayer, are disclosing only the results on newly approved products, while others, including GlaxoSmithKline ($GSK) and Johnson & Johnson ($JNJ), have agreed to hand over huge swaths of anonymized data in the interest of global R&D.
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