, professor of biostatistics and dean of the UCLA Fielding School of Public Health, co-authored a New England Journal of Medicine
Sounding Board article advocating the development of a new approach to clinical trials conducted during pandemics such as COVID-19.
The article’s authors—who serve as members of the World Health Organization (WHO) R&D Blueprint
, which aims to allow “the rapid activation of R&D (research and development) activities during epidemics”—suggest a “core-protocol concept” to clinical trials, which could, for example, be applied across infectious disease outbreaks and allow for the addition of new team members over time. They also address the need for cooperation and early engagement with government officials, regulatory agencies and ethics committee, as well as coordination across funding agencies.
The researchers share: “Core protocols are rapidly being developed by the WHO for trials assessing the efficacy of therapies and vaccines that are being developed to combat this infection. Implementing clinical trials for treatments during disease outbreaks under a core protocol could increase the chances of efficiently generating reliable evidence to determine which therapies are effective, thus providing timely information to public health officials and clinicians caring for patients.”
“Creating a Framework for Conducting Randomized Clinical Trials during Disease Outbreaks”
appears in the April 2, 2020 issue of the New England Journal of Medicine
. Authors include: Natalie E. Dean, Pierre‑Stephane Gsell, Ron Brookmeyer, Forrest W. Crawford, Christl A. Donnelly, Susan S. Ellenberg, Thomas R. Fleming, M. Elizabeth Halloran, Peter Horby, Thomas Jaki, Philip R. Krause, Ira M. Longini, Sabue Mulangu, Jean‑Jacques Muyembe‑Tamfum, Martha C. Nason, Peter G. Smith, Rui Wang, Ana M. Henao‑Restrepo, and Victor De Gruttola.