Drugmakers, medical devicemakers owe a decade's worth of clinical trial data, NIH says

The National Institutes of Health has warned drugmakers and medical devicemakers to post a decade's worth of missing clinical trial data to a public database following a court order, STAT reported. 

Between 2007 and 2017, many clinical trials were exempt from reporting their data to ClinicalTrials.gov, a public database, meaning data about approved drugs and medical devices were never made public. 

A federal court order in February instructed clinical trial sponsors to submit the missing data, but many still haven't. 

The NIH sent a letter to trial sponsors July 30 telling them to upload the data "as soon as possible," but didn't provide a solid timeline, according to STAT

Advocates have argued that transparency is critical for the public's understanding of a drug or medical device's safety and efficacy. 

Despite the court order and the letter from the NIH, experts still worry that agencies won't enforce the transparency rule. Christopher Morten, PhD, a supervising attorney at New York University's Technology Law and Policy Clinic, told STAT the FDA and NIH have never imposed fines on trial sponsors for failing to report data, but they could if they wanted to. 

Read the full article here.

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