martes, 4 de agosto de 2020

NIH warns drug and device companies to post missing trial data

NIH warns drug and device companies to post missing trial data

Morning Rounds

Shraddha Chakradhar

Inside STATNIH warns drug and device companies to post missing trial data

Advocates for clinical trial transparency just scored a major win in court over a decade's worth of missing data. Following a February ruling that said hundreds of drug device manufacturers, pharma companies, and institutions had to submit data missing from the federal portal ClinicalTrials.gov "as soon as possible," federal officials are choosing not to contest that decision and are now warning that these trial sponsors will be on the hook for producing the missing data. Still, it's unclear how many companies that have been noncompliant have actually received warnings from the NIH, which has also not specified a timeline for submitting the data. “This is a case about the public’s right of access to clinical trial results,” attorney Christopher Morten tells STAT's Lev Facher. Read more here

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