WASHINGTON — For years, government research agencies have misinterpreted a law that requires them to collect and post clinical trial data, a federal judge ruled this week, leaving behind a 10-year gap in data that now must be made publicly available.
Now, potentially hundreds of universities, drug companies, and medical device manufacturers are on the hook to release previously unpublished data. The ruling affects trials conducted for as-yet-unapproved drugs and devices in that 10-year stretch, according to a lawyer for the plaintiffs — meaning hundreds or even upwards of 1,000 noncompliant trials would be forced to post data.
The ruling, from a federal judge in New York’s Southern District, puts sponsors of clinical trials during that span out of compliance if they have not posted results to the government repository ClinicalTrials.Gov.
“This decision brings us one step closer to what federal law requires — providing the American public with complete access to clinical trial results on drugs and medical devices approved by the FDA,” said Christopher Morten, a supervising attorney at New York University’s Law & Policy Clinic who represented the plaintiffs. The ruling, he said, “makes it harder for drug companies, device manufacturers, and other trial sponsors to keep unfavorable trial results secret.”
The plaintiffs in the lawsuit are Peter Lurie, formerly an associate FDA commissioner who worked on transparency issues, and Charles Seife, a New York University journalism professor who has written for Science and other outlets.
A STAT investigation in 2015 revealed widespread inconsistencies in how top research universities report clinical trial data. The NIH said then that the 2017 regulations, which had not been published at the time, would give it “a firmer basis for taking enforcement actions” against institutions that fail to report.
Subsequent reporting in Science magazine has revealed that despite the transparency requirements, FDA has never imposed a fine on a clinical trial’s sponsor, and the National Institutes of Health has never publicly named or withheld grant funding.
Seife has argued that the federal government’s decision to not require data from a decade’s worth of clinical trials “effectively wiped the slate clean” for his future reporting.
“The FDA is in charge of making sure that drugs on the market are safe and effective, but without access to data about those drugs, it’s nearly impossible to understand whether the agency is doing its job properly,” Seife said in a statement on Tuesday.
While some clinical trial sponsors that did not post data between 2007 and 2017 are now officially out of compliance with the federal regulation, it’s unclear how quickly they’ll be required to post their results —and what the consequences might be if they don’t.
A spokeswoman for the Department of Health and Human Services said the agency was “evaluating the Court’s decision with the Department of Justice to determine our next steps.” A spokeswoman for the Food and Drug Administration declined to comment.
Unless the fines for non-compliance is substantial, this ruling would have no effect IMO. Any fine calculation should be based on a hard-wired multiplier based on which drug, which trial, and how many days tardy. Perhaps consider throwing in the drug’a list price as well, so the more costly the drug, the higher the fine! You must hurt these companies where it hurts the most!!
An important ruling. Too many of our daily decisions as patients and doctors are based on inadequately reported data. Sometimes this inadequacy is intentional on the part of the pharma companies. Mandated reporting of clinical trial results is one important step toward reducing the bias that exists toward reporting of positive studies over negative ones.
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