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. The Declaration of Helsinki is a set of ethical principles regarding experimentation on humans developed by the World Medical Association, which states that every clinical trial must be registered and report its results. 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.

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 research universities have had to post the results of 450 clinical trials. However, 31% of those trials are still missing results on the public registry, in violation of the FDA Amendments Act. 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.

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 becoming signatories of the World Health Organisation’s joint statement on public disclosure of results from clinical trials and committing to fully implement its provisions.

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Under-reporting of clinical trials on ClinicalTrials.gov

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of all applicable clinical trials on ClinicalTrials.gov, the world's largest clinical trials register, have not reported results (AllTrials).

Thus far, the US government has collected $0 in fines despite extensive violations of transparency laws.1

Taxpayer money for university and medical schools biomedical research

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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)2

Effects 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

Under-reported university-driven trials from 2007 to 2017

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From 2007 to 2017, 2,896 university-driven trials (79%) failed to post summary results within 12 months of trail completion, in violation of the law.

As of September 2017, universities had still not posted the results for 780 trials (24%) they sponsored.4

See Source

  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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