MFIA, CRIT Sue Government Over Clinical Trial Data

On July 18, 2018, the Media Freedom and Information Access Clinic (MFIA) filed a complaint on behalf of the Yale Collaboration for Research Integrity and Transparency (CRIT), urging a federal district court in Connecticut to compel the Department of Health and Human Services (HHS), the National Institutes of Health (NIH), and the Food and Drug Administration (FDA), to comply with their legal obligations to notify the public of researchers’ failure to report clinical trial results on ClinicalTrials.gov.

In 1997, Congress required HHS to begin collecting and disseminating clinical trial data for trials studying treatments for serious or life-threatening diseases. The lawsuit outlines how NIH created ClinicalTrials.gov in response to serve as the public repository for the data. In 2007, Congress greatly expanded the ClinicalTrials.gov registration and reporting requirements, requiring researchers for many types of clinical trials to register their trials and report results after completion. In addition, Congress required NIH to post public notices of non-compliance whenever a researcher fails to comply with its reporting obligations. HHS issued a final rule in January 2017 that implements these expanded requirements, according to the clinic.

The data Congress required be published on ClinicalTrials.gov is a critical resource for clinicians, patients, researchers, policymakers, regulators, and the general public, according to the lawsuit. It helps clinicians and their patients make more informed decisions about treatment options, allows patients to locate and enroll in clinical trials, and enables researchers to more comprehensively summarize existing evidence and avoid duplicating studies unnecessarily.

Over the past decade, however, those involved in the lawsuit said there has been widespread and well-documented failure by researchers to report and update required information on ClinicalTrials.gov. NIH has failed to post even a single required public notice, according to the lawsuit.

"The failure to post notices violates HHS, NIH, and FDA’s statutory obligations," said John Langford ’14, Clinical Lecturer in Law. "More importantly, it deprives CRIT’s researchers, as well as other researchers, clinicians and patients, of essential data necessary to study the integrity of the clinical trial research enterprise and evaluate the evidence supporting medical product safety and effectiveness."

Additionally, HHS’s final rule created a loophole that purports to allow some clinical trials completed before January 2017 to not report results. This violates both the language and the intent of Congress’s 2007 expansion of ClinicalTrials.gov’s reporting requirements, according to the lawsuit.

To address NIH’s failure to post notices, and the loophole in HHS’s final rule, CRIT has filed suit under the Administrative Procedure Act. The suit seeks an order requiring NIH to begin posting public notices whenever a researcher fails to comply with their reporting obligations. It also asks the court to strike down the loophole that permits certain clinical trials to avoid reporting results.

“HHS, NIH, and FDA have made great strides forward in clinical research transparency in the past 20 years,” explained Dr. Joseph Ross, Associate Professor of Medicine and Public Health at Yale, “allowing researchers to gain critical insights into the strengths and limitations of the evidence for a multitude of clinical interventions, from drug products to medical devices to behavioral programs. We hope this suit will motivate the federal government to post failure to comply notices, which will foster greater accountability among clinical researchers and further strengthen clinical research transparency in the U.S.”

MFIA Summer Fellow Christine D’Alessandro said “Clinical trial results contain valuable information about the safety and effectiveness of new medicines and medical technologies.  It is critical that these results are made publicly available to better facilitate patient access to information that may affect their decisions on treatment options.”

View the full complaint and exhibits.

MFIA is a student clinic at Yale Law School dedicated to increasing government transparency and advancing the public’s right of access to information. CRIT is an interdisciplinary initiative at Yale University devoted to improving the quality and transparency of the research base for medical products. 

Clinic students Abby McCourt ’20, Simon Brewer ’20, Adam Pan ’18, Georgia Travers ’19, and Isabel Farhi ’19, and MFIA Summer Fellow Christine D’Alessandro worked on this case under the supervision of Langford.

In addition, the team was assisted by David Schulz ’78, co-Director of the MFIA Clinic; Amy Kapczynski ’03, Professor of Law and Faculty Director, Global Health Justice Partnership at Yale Law School; Margaret McCarthy, Research Scholar in Law and Executive Director at CRIT; Joseph Ross, MD, Associate Professor of Medicine (General Medicine) and Public Health (Health Policy) at the Yale School of Medicine; and Joshua Wallach, PhD, Research Associate at CRIT.