New Ruling to Expand Public Access to Clinical Trial Data

A federal judge ruling last week will significantly expand the public’s right to access results of clinical trials studying drugs and medical devices, according to a recent press release.

Judge Naomi Reice Buchwald recently ruled that the FDA and National Institutes of Health (NIH) misrepresented the 2007 law that required drug companies, universities, and other sponsors of clinical trials to post the clinical trial results of FDA approved-products to the public, the press release stated.

The court order requires the government to collect and release nearly ten years’ worth of clinical trial results that should have been public under the law. 

This ruling is the latest update in a lawsuit by the Yale Media Freedom and Information Access (MFIA) and NYU Technology Law & Policy (TLP) Clinics on behalf of Charles Seife and Peter Lurie, MD, with the support of the Yale Collaboration for Research Integrity and Transparency (CRIT). 

“Judge Buchwald’s decision will help ensure that these government agencies and the drug and device industries are jointly held to account, and that the promise of the clinicaltrials.gov database be finally fulfilled,” Lurie said. 

Drug companies and other sponsors of clinical trials tend to “cherry-pick” data by publishing bias clinical results and keeping some records to themselves. But high-quality medical care requires high-quality evidence, so this significant challenge must be addressed, the lawsuit argued.

“True transparency requires that all results of clinical trials be truthfully reported, be they positive, negative, or somewhere in between,” Lurie continued. “Even in cases where the study sponsors or FDA would prefer not to disclose.” 

Christopher Morton, supervising attorney at the TLP Clinic, emphasized that Congress ordered the FDA Amendments Act (FDAAA) to guarantee a smooth transition of clinical trial evidence to patients, clinicians, and researchers through the public ClinicalTrials.gov website 

But NIH and HHS publicized a rule and interpretation of FDAAA that created a secret loophole.

“The loophole purported to exempt many clinical trials of FDA-approved products completed between 2007 and 2017 from any obligation to ever report their results to ClinicalTrials.gov,” Simon Brewer, MFIA student said. 

Selfie and Lurie claimed that their research has been delayed due to the absence of information on ClinicalTrials.gov. 

Seife stressed how important the law is to ensure safe and effective drugs are on the market. But without access to drug data, it is challenging and nearly impossible to uncover if the FDA is doing its job efficiently. 

In December 2018, MIFIA filed a lawsuit on Seife and Lurie’s behalf which would close the loophole and request a declaration that NIH’s and HHS’s interpretation of FDAAA was inconsistent with the law.

The decision to publicize a decade’s worth of trial results was a victory for Seife and Lurie on their loophole claim. 

Although the court could not grant relief on a separate claim that asked for an order requiring NIH to post public notices of noncompliance when drug companies, universities, and other sponsors of clinical trials fail to submit results, the recent court order is considered a victory. 

“This is an extraordinary victory for patients and clinical trial researchers,” said Joseph Ross, professor of medicine and public health and faculty co-director of Yale CRIT. “The government now has a clear legal obligation to enforce these reporting requirements, and by doing so it will promote more fully-informed decision-making by patients and their clinicians.”