The NIH intramural research program has shifted all non-mission-critical laboratory operations to a maintenance phase in order to promote physical distancing and diminished transmission risk of COVID-19. Effective Monday, March 23, 2020, only mission-critical functions within NIH research laboratories will be supported.

Clinical Trial Capacity Working Group

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Charge

Develop an inventory of clinical trial capacity, including networks from NIH Institutes and Centers and contract research organizations (CROs), that will serve as potential settings in which to implement effective COVID-19 clinical trials. The working group completed its charge as of July 31, 2020.

Objectives

Check mark indicates completion.

✓ Clinical Trial Capacity Survey and Inventory

The working group developed and launched a series of three clinical trial capacity surveys that included questions designed to identify the capabilities of more than 60 networks, over 700 clinical trial sites, and over 30 CROs and site management organizations (SMOs). The results of these surveys were combined with geographic mapping, COVID-19 disease incidence data, and visualization capabilities into a unique “geotracking tool” that has enabled the ACTIV therapeutics and vaccines clinical trial teams to choose the most effective networks and sites to support ACTIV master protocols and associated trials.

✓ Clinical Trial Innovations and Resources

The working group created a reference guide for novel clinical trial innovations along with a resource map of available solutions to help enable the safe and efficient conduct of ACTIV clinical trials under the unique conditions imposed by the COVID-19 pandemic. Working group members worked with healthcare professionals conducting clinical trials sponsored by ACTIV and its partners to identify useful solutions for ACTIV clinical trials.

Members

Lionel Bascles, Ph.D.
Senior Vice President, Global Head of Clinical Sciences & Operations
Sanofi

Myron Cohen, M.D.
Associate Vice Chancellor for Global Health and Medical Affairs
Yeargan-Bate Distinguished Professor of Medicine, Microbiology and Immunology, and Epidemiology
Director, Institute for Global Health & Infectious Diseases
University of North Carolina, Chapel Hill

Lawrence Corey, M.D.
Professor, Departments of Laboratory Medicine & Medicine
Member, Division of Vaccine & Infectious Disease (VIDD), Clinical Research, & Public Health Sciences
President & Director Emeritus
Fred Hutchinson Cancer Research Center

Victoria Davey, Ph.D., M.P.H.
Associate Chief Research & Development Officer, Epidemiology and Public Health
U.S. Department of Veterans Affairs

Elizabeth Desrosiers, M.S., P.M.P. (Co-Chair)
Executive Director, Clinical Sciences and Study Management
Merck & Co., Inc.

James Dickens
Program Manager, Office of Rare Diseases Research
National Center for Advancing Translational Sciences, NIH

Jim Doroshow, M.D.
Director, Division of Cancer Treatment and Diagnosis
National Cancer Institute, NIH

Carlos Garner, Ph.D.
Vice President, Global Regulatory Affairs
Eli Lilly and Company

David Goff, M.D., Ph.D.
Director, Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute, NIH

Penny Heaton, Ph.D.
Chief Executive Officer
Bill & Melinda Gates Medical Research Institute

Michael Kurilla, M.D., Ph.D. (Co-Chair)
Director, Division of Clinical Innovation
National Center for Advancing Translational Sciences, NIH

George Mensah, M.D.
Director, Center for Translation Research & Implementation Science
National Heart, Lung, and Blood Institute, NIH

Seema Nayak, M.D.
Director, Office of Clinical Research Resources
National Institute of Allergy and Infectious Diseases, NIH

Manizhe Payton, M.P.H.
Director, Office of Clinical Site Oversight, DAIDS
National Institute of Allergy and Infectious Diseases, NIH

Laura Resnansky, B.S.N.
Vice President, Global Head of Clinical Operations - Immunology, Infectious Diseases, Ophthalmology and Neuroscience
Genentech

Christine Sizemore, Ph.D.
Director, Division of International Relations
Fogarty International Center, NIH

Badhri Srinivasan, A.B.D., M.S.
Head, Global Development Operations
Novartis

Peter Stein, M.D.
Director of Office of New Drugs
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

Therese Takas
Director, Clinical Operations
AstraZeneca

Mike Vincent, M.D., Ph.D.
Senior Vice President and Chief Scientific Officer of the Inflammation and Immunology Research Unit
Pfizer

Gail Weinmann, M.D.
Deputy Director, Division of Lung Diseases
National Heart, Lung, and Blood Institute, NIH

This page last reviewed on September 11, 2020