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A Few Data Points, Please

The US National Institutes of Health is urging clinical trial sponsors to add in years of missing data, Stat News reports.

It reported in 2015 that a number of research institutes were tardy in reporting — or never reported — clinical trials results to, and in January Science found that the Food and Drug Administration has never fined a trial sponsor for not disclosing results and NIH has never named or revoked funding from an institute that did not disclose results.

Following a lawsuit brought by Peter Lurie, a former associate FDA commissioner, and Charles Seife, a New York University journalism professor, a federal judge ruled in February that drug companies, device manufacturers, and universities needed to add data from hundreds of studies to The judge found that the NIH and the FDA had misinterpreted a law that required them to collect and post such data.

According to Stat News, NIH issued new rules last week calling on trial sponsors to submit missing data from trials conducted between 2007 and 2017 "as soon as possible," but it notes no timeline is named. The plaintiff's attorney, Christopher Morten from New York University's Technology Law and Policy Clinic, tells it he is "cautiously optimistic" that sponsors will comply.