miércoles, 26 de febrero de 2020

Decade's worth of clinical trial data has to be reported, judge rules

Morning Rounds
Shraddha Chakradhar

Decade's worth of clinical trial data has to be reported, judge rules

In 2007, the U.S. government mandated that clinical trial sponsors report results within a year after the trial's completion, but rules on how the law would be enforced weren't clarified until 2017. Now, a federal judge in New York has ruled that trial sponsors have to report results from research conducted in the decade between 2007-2017, handing a win to data transparency proponents. The ruling means that hundreds of universities, medical device manufacturers, and drug companies are now on the hook for reporting results from several hundred — if not thousands — of trials they conducted since the law was passed in 2007. Many of these entities had previously argued that because enforcement action wasn't made clear until 2017, the decade prior shouldn't count. It's unclear now how long institutions have to report the missing data and what the consequences will be for noncompliance. 

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