WASHINGTON — Hundreds of drug companies, medical device manufacturers, and universities owe the public a decade’s worth of missing data from clinical trials, federal officials warned last week.
The failure to publish the results of a clinical trial is not merely a technical breach, nor is it a regrettable reality for sponsored trials. Not publishing a failure or an unexpected outcome puts lives at risk and creates waste, when later researchers try the same experiment, not realising it’s already been tried unsuccessfully. It’s way past time that the standards already on the books were enforced. The AHRECS team is involved in an effort to make this compulsory in Australia.
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The court’s ruling, and the federal government’s decision not to appeal it and instead to urge trial sponsors to submit the missing information, represent a major win for transparency advocates, who for years have fought to recover the decadelong gap in publicly available clinical trial data.
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“This is a case about the public’s right of access to clinical trial results,” said Christopher Morten, a supervising attorney at New York University’s Technology Law and Policy Clinic, who represented the plaintiffs. “Now, with the court’s decision, those trial results are very clearly required, and the trial sponsors have a legal obligation to report them.”