[Ip-health] NEW UAEM REPORT: One third of US universities are in violation of a key transparency law

Merith Basey merith at essentialmedicine.org
Mon Mar 25 06:29:56 PDT 2019


*One third of clinical trials run by America’s top research universities
are in violation of a key transparency law, according to new report *

WASHINGTON, DC & BRISTOL, UK: {25 March 2019], By law, since 2017,
America’s top research universities 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, according to the
report released today via www.altreroute.com/clinicaltrials by Universities
Allied for Essential Medicines (UAEM) in partnership with TranspariMED, a
non-profit research advocacy group.

Timely clinical trial reporting helps researchers avoid creating
duplicative studies and guards against fraud and reporting bias, in which
scientists selectively publish “successful” results only. Clinical trial
transparency accelerates medical progress for new treatments, improving
understanding of treatment efficacy and safety, ultimately contributing to
improved access to medicines and better health outcomes.

Universities Allied for Essential Medicines <https://uaem.org/> (UAEM), a
global student-driven organization, is leading a campaign to push their own
institutions to become the first research universities in the world to sign
onto the World Health Organization (WHO)’s Joint Statement
<https://www.who.int/ictrp/results/jointstatement/en/> on Clinical Trial
Transparency, formally committing to meeting global best practices in
medical research transparency.

“We advocate full transparency of which clinical trials are ongoing and
ensuring all results are disclosed in a timely manner in accordance with
the WHO Joint Statement on disclosure of results from clinical trials,”
said Dr Tedros Adhanom Ghebreyesus, WHO’s Director-General. “This is
consistent with the principal goal of medical research: to serve the
betterment of humanity. In the case of clinical trials, full transparency
on results advances both scientific understanding and timelines for product
development and ultimately enables access to essential medicines. We would
welcome Universities joining as signatories.”

Jackie Xu, UAEM Student Leader at Duke University shared, “ Universities
play a key role in the world of scientific and clinical which is often
funded through taxpayer-based dollars. Students and future alumni, like
myself, are uniquely positioned to demand that the institutions that
both *represent
them* and that *they represent *to do better. I am proud that Duke
University has been reporting at 100% compliance with FDA Amendments Act
since 2017, but I hope Duke can take the next step forward and publically
commit to clinical trials transparency with the WHO statement. This is a
standard global practice. We have the obligation to at least fulfill this.”

The current list of violators includes major trial sponsors. For example,
the academic institution sponsoring the most applicable trials, MD Anderson
Cancer Center, has only reported 77% of due trials. Mayo Clinic (42%), UC
San Francisco (37%), New York University (21%), and Columbia University
(17%) perform even worse. While some universities continue to violate the
Food and Drug Administration (FDA)’s 2007 and 2017 clinical trial
transparency law requirements for research reporting, others have invested
considerable resources into ensuring timely disclosure of trial results and
retroactively publishing to clear backlogs of previously unreported

Prior to 2015 the universities of Indiana, North Carolina Chapel Hill,
Rochester, Pittsburgh and Yale had an extensive backlog of unreported trial
results. They have since successfully cleared over 85% of their backlogs.
Stanford (65 trials), Johns Hopkins (47), and Pittsburgh (45) posted most
trial results.

An estimated 50% of all new medical innovations and technologies are
developed by universities using taxpayer dollars via grants from the
National Institutes of Health.

“As institutions with social missions, universities are morally bound to be
transparent with their research outcomes especially when trials are
publicly-funded in the first place” said Merith Basey, Executive Director
of UAEM North America. “We are urging universities to step up their
commitments by becoming the first universities worldwide to sign onto the
WHO Statement, following in the footsteps of leading groups like Doctors
without Borders, Drugs for Neglected Diseases Initiative and The Wellcome

Without strong federal oversight on reporting requirements, advocates from
UAEM and TranspariMED hope to shine a light on this practice and pressure
universities to fulfill their missions that serve the public interest.

The launch of the report via (www.altreroute.com/clinicaltrials/) is a
student-driven campaign that forms part of UAEM’s larger push for a more
equitable, transparent, collaborative and patient-centered biomedical
Research and Development (R&D) system, in which university-driven clinical
trials play an important role.

“Patients and taxpayers are paying a steep price while law-breaking
companies and universities walk free. The FDA should start by enforcing the
law by imposing fines immediately to prevent important medical discoveries
from becoming lost forever,” said Dr. Till Bruckner, the founder of

*About UAEM and TranspariMED:*

*Universities Allied for Essential Medicines (UAEM)* <http://www.uaem.org>
is a global network of university students organizing on their campuses and
beyond to ensure that publicly funded medicines is accessible and
affordable for all, regardless of income. UAEM believes that Universities
and publicly funded research institutions will be part of the solution to
the access to medicines crisis by promoting medical innovation in the
public interest and ensuring that all people regardless of income have
access to medicines and other health-related technologies.

*TranspariMED* <https://www.transparimed.org/about> is a global initiative
that develops and promotes policy solutions to improve clinical trial

*www.altreroute.com* <http://www.altreroute.com/clinicaltrials>/clinicaltrials,
a microsite and report launched today by UAEM in conjunction with
TranspariMED, provides performance data for the 40 major U.S. universities
that have sponsored the largest number of trials subject to the FDA
Amendments Act of 2007 (FDAAA).


Merith Basey

Executive Director, UAEM North America

merith at uaem.org

*Merith Basey MSc* (she/her)
Executive Director, North America
Universities Allied for Essential Medicines <http://uaem.org/>
@uaem @globalDiaBEATes

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