The role of universities in a more equitable biomedical R&D system

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At least half of the most innovative and life-saving medicines that exist today were originally developed in university labs with taxpayer funding. This includes almost all vaccines, many HIV-AIDS and tuberculosis drugs, and even insulin. In the United States, every single one of the 210 most recently approved medicines by the US Food and Drug Administration (FDA) can be traced back to funding from the National Institutes of Health (NIH), a government agency run with taxpayer dollars.*http://www.pnas.org/content/early/2018/02/06/1715368115

Clinical trials are experiments carried out in clinical research that are designed to evaluate a treatment’s impact — positive or negative — on the health of people. In 2007, the US Congress passed the Food and Drug Administration Amendments Act (FDAAA), requiring universities to post the results of clinical trials on Clinicaltrials.gov (a public database of clinical trials) within a year of trial completion. By law, since 2017, America’s top 40 research universities have had to post the results of 1,516 clinical trials. However, 101 of those trials are still missing results on the public registry, in violation of the FDA Amendments Act. In addition, due to the recent court ruling for a lawsuit filed against the FDA, HHS, and NIH, clinical trials sponsors are now mandated to retrospectively report trials from 2007 and onwards, when the FDAAA was enacted. This will allow for thousands of publicly-funded clinical trials from a decade of research to be recorded and made accessible for all.

Clinical trial transparency is critical for physicians to make informed decisions when prescribing medicines and for researchers to avoid duplicating studies. The failure to comply with US legal requirements in disclosing trial results squanders public funds, hurts patients, and slows the pace of discovering new treatments and cures. The timely disclosure of results helps to improve public health outcomes over time by reducing waste in research, increasing efficiency in the use of resources, limiting reporting bias and contributing to enhanced decision-making.

The COVID-19 pandemic has demonstrated that clinical trial data crucially informs the global community’s response to emerging health crises by informing clinical and regulatory decision-making. For instance, the FDA’s initial emergency use authorization for remdesivir as a potential COVID-19 treatment in May 2020 was based upon early-stage clinical data which suggested that the therapy could potentially be effective against the virus. Such regulatory decisions exemplify the importance of clinical trial transparency in ensuring public safety and trust during a rapidly evolving landscape for biomedical innovation. The universities mentioned in this report have received millions of dollars in public funding for coronavirus-related research. Moreover, accurately reported clinical trial results remain the best way for the researchers, policymakers, and the public to see that drug and vaccine development is progressing in a safe and trustworthy manner – a feat that corporate press releases alone simply cannot achieve.

Universities must make public all of their clinical trial protocols and results — past, present and future — on public registries. UAEM urges universities to live up to their social missions and become leaders in the drive for greater clinical trial transparency by maintaining 100% compliance under the FDAAA.

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Under-Reporting of Clinical Trials on ClinicalTrials.gov

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Approximately 1 in 3 applicable clinical trials registered on ClinicalTrials.gov, the world’s largest clinical trial register, have failed to report results. (FDAAA Trials Tracker)

The US government is currently due to collect over $16 billion in fines for late or unreported trial results. As of March 2021, it has collected $0, despite extensive violations of reporting requirements.

Taxpayer Money for Biomedical Research At Universities, Medical Schools, and Affiliated Cancer Centers

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The NIH gives $41.7B of US taxpayer money to 2,500+ universities and medical schools annually to do basic biomedical research. In 2017, about 40% went into clinical research, clinical trials, and supporting activities (NIH)2

Impact of Failure to Register and Report Clinical Trials

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The failure to register and report clinical trials results in duplicative studies and incomplete and biased reporting of trials results, distoring the picture of how effective new medicines really are. This squanders public funds, hurts patients, and slows the pace of discovering new treatments and cures.

Clinical trial transparency accelerates medical progress for new treatments, improving understanding of treatment efficiency and safety, ultimately contributing to improved access to medicines and better health outcomes.3

Clinical Research for COVID-19 at US Universities

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As of March 2021, there are over 2,600 ongoing clinical trials concerning COVID-19 health technologies being conducted. Of the 40 institutions included in this report, 26 are actively engaged in such clinical research, and 9 others are running preclinical studies, reaffirming the relevance and importance of timely reporting of clinical trials data during the pandemic. (Global COVID-19 Clinical Trial Tracker)

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  1. Source: Ross et al, 2009, which found that 46% of trials on ClinicalTrials.gov, the world’s largest clinical trials register, had reported results.

  2. The NIH gives $37B of US taxpayer money to 2,500+ universities and medical schools annually to do basic biomedical research. In 2017, 38% went into clinical research, clinical trials, and supportive activities (NIH)

    Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4508873/

  3. See UAEM TranspariMed Full Report for more information

  4. See UAEM TranspariMed Full Report for more information

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