Researchers Urge Greater Transparency for Government-Funded Vaccine Trials

More than two dozen researchers and experts have penned a letter to HHS Secretary Alex Azar, National Institutes of Health (NIH) officials and pharma company executives, imploring them to shed more light on the clinical trial designs for federally funded COVID-19 vaccine studies.

The group — which includes bioethicist Arthur Caplan, founder of New York University School of Medicine’s Division of Medical Ethics, and Peter Lurie, a former FDA associate commissioner for public health strategy and analysis — argued that more details need to be shared about the designs of ongoing, government-funded COVID-19 vaccine trials in order to improve public trust in vaccines and aid in their development.

“More openness will improve public confidence by allowing independent researchers to validate trial protocols and identify any modifications that could improve them,” the experts wrote. “Transparency is one of the few tools at our disposal for increasing public trust in any vaccine proved safe and effective. It will also help protect the long-term reputation of our nation’s public health agencies and enable researchers to better contribute at this moment of great public need.”

While the experts commended AstraZeneca, Johnson & Johnson, Moderna and Pfizer for publicly sharing information about their vaccine trial protocols and said their actions “sparked rapid review by independent scientists who both critiqued and endorsed the trial design,” they called for the release of certain documents to allow for further scientific evaluation.

For example, they requested all versions and amendments of trial protocols for each phase of clinical trials under Operation Warp Speed, statistical analysis plans for ongoing and completed trials, trial stopping rules, and charters for data and safety monitoring boards.

They also asked for blank case report forms and blank model consent forms from trials both finished and ongoing, minutes of Institutional Review Board (IRB) meetings for all trials and clinical trial agreements with the NIH and other relevant agencies.

“Though detailed trial design documents are not routinely shared in advance with researchers and the public, the stakes here are enormous and justify this step,” they wrote, noting that they believe sharing the information would not violate patient privacy or put commercial secrets in jeopardy.

The letter’s authors requested a statement be released by Oct. 27, outlining all the relevant information held by HHS agencies, including FDA and NIH, and a schedule for that information’s release to the public.

Read the letter here: www.fdanews.com/10-21-20-openletter.pdf. — James Miessler