2021 Transparency Report Released

New UAEM report finds many U.S. universities are still violating federal clinical trial transparency guidelines

FDA could collect over $19 billion in fines

May 26, 2021--Washington, DC--Transparency matters, and adhering to federal clinical trial requirements matters now more than ever as the global coronavirus pandemic continues to ravage the globe and countries fight and plead for access to vaccines, technology, vaccines, and know-how. A new report by Universities Allied for Essential Medicines (UAEM) acknowledges the significant progress made by many leading universities in this area over the last two years, but also condemns the repeat worst offenders, including the University of Colorado, Denver, University of Washington, New York University Langone Health, University of Cincinnati, and Stanford University. 

Clinical Trial Transparency at U.S. Universities: A New Report Measuring Legal Compliance with Clinical Trial Reporting Obligations in 2021 analyzes clinical trial reporting data from the top 40 U.S. research institutions (both public and private). This updated version of the report first published in 2019 includes several university-affiliated cancer research centers and medical schools. The report also includes the impact of the recent court ruling that upheld that the earlier FDA ruling on trial mandates stands, as well as the implications of transparency amidst the COVID-19 pandemic. 

"Every clinician's worst nightmare is to prescribe a treatment to a patient without knowing just how truly safe and effective it is. Only through transparency of clinical trial results can we be assured. This report shows that while universities -- where many of us work as providers -- have improved, many continue to be complicit in failing to report their clinical trial results, putting our patients at risk," said Reshma Ramachadran, Physician Fellow at the Yale National Clinicians Scholars Program.

“UAEM’s new report is another landmark and will undoubtedly spark more improvement in universities’ reporting of trial results. But UAEM can’t fight this fight on its own. FDA and NIH must, after years of inaction, begin actively monitoring and enforcing all trial sponsors’ compliance with the law,” said Chris Morten, Deputy Director of NYU’s Technology Law and Policy Clinic. 

This troubling data follows an earlier announcement by the FDA in which they issued a warning of noncompliance to Acceleron Pharmaceuticals. Following UAEM and New York University Technology Law and Policy Clinic FOIA request in March, the FDA issued what could be one of many warnings to pharmaceutical corporations, universities, and research institutions. 

“This report covers a subset of the hundreds of universities that are non-compliant under the FDAAA, and we hope the effects of this report will impact other sponsors, as well. We can only declare victory once all universities have reported 100% of their clinical trials, as mandated by the law,” said Neelima Paleti, UAEM North American Coordinating Committee Member (NACC). 

Here are some of the report’s key findings: 

  • The total number of registered clinical trials increased from 446 to 1516 between February 2019 and February 2021. 
  • The number of research institutions legally compliant under FDAAA (100% of clinical trials reported) increased from 13 to 17. 
  • The total number of unreported trials has decreased from 138 to 101. 

Another UAEM NACC Member, Defne Yorgancioglu, further stated: “Until COVID-19, many people may not have recognized the weight that even a single clinical trial’s results can hold. However, over the last year, we have seen firsthand just how critical this information can be when developing ways of treating diseases under uncertainty. Patients struggling with rare or complex health conditions face this kind of uncertainty every day, and consistent reporting of clinical trial results is critical for enabling physicians to provide them with the best care possible.”

Merith Basey, Executive Director for UAEM North America, added, “Obtaining transparency in clinical trials is a critical step towards achieving a more just, people-centered R&D system. While COVID-19 has exacerbated the existing structural and racial inequities of the health system, including the role of universities, UAEM students are choosing to hold their institutions accountable in achieving health equity”.

This report follows the release of the newly updated COVID-19 Mapping Tool launched last month and the 2020 U.S. University Report Card: Global Equity and Biomedical Research published in March. The COVID-19 Mapping Tool was first released in May 2020 in immediate response to the rapid injection of public money all over the world to accelerate the COVID-19 response. The update includes new data, additional countries, methodological refinements, and website features. UAEM’s analysis boldly emphasizes the crucial role of public funds provided to public research institutions to innovate health technologies against COVID-19. Likewise, the Report Card is a critical study of the top sixty research universities in the States scrutinizing their biomedical research and development (R&D) policies, practices, and performance in domestic and neglected global public health needs in access to medicines, including their COVID-19 response. 

To read the report, click here

###

 

About Universities Allied for Essential Medicines (UAEM)

Universities Allied for Essential Medicine (UAEM) is celebrating 20 years of student activism and advocacy in the global and domestic fight for health equity and justice in access to medicines. UAEM is rooted in a global movement of university students in 20 countries and aims to (1) promote access to medicines and medical innovations where barriers exist primarily by changing norms and practices around academic patenting and licensing, supported by our own independent research, (2) ensure that university medical research meets the needs of people worldwide and actively supports the creation of new needs-based approaches to R&D, and (3) empower students to respond to the biomedical access and innovation crisis by advocating for the most promising global biomedical R&D system that works for all. http://www.uaem.org