To learn from the evolving lessons of addressing the COVID-19 pandemic and to bolster the future use of real-world data (RWD) and real-world evidence (RWE), The FDA Foundation, in collaboration with the International Society for Pharmacoepidemiology (ISPE), created The COVID-19 Real-World Evidence Primer. The Primer consists of seven chapters that cover types of RWD, methods in RWE generation, examples of RWE studies and initiatives, and strategies for communicating about RWE.
A Note from the Editorial Committee
In the early phase of the SARS-CoV-2 (COVID-19) pandemic, the Reagan-Udall Foundation for the Food and Drug Administration (FDA Foundation), in collaboration with Friends of Cancer Research, and at the request of the FDA, launched the COVID-19 Evidence Accelerator to rapidly share information on the epidemiology, prevention, and treatment of COVID-19. Much of the information shared and generated through the parallel approach to analyses leveraged real-world data (RWD). Through the Evidence Accelerator, the FDA Foundation in collaboration with the International Society for Pharmacoepidemiology (ISPE) has developed this COVID-19 Real-World Evidence Primer to provide an overview of available RWD sources and appropriate methods for study conduct. An Editorial Committee comprising representatives from the FDA Foundation and ISPE guided the development of this primer, and committees of authors were responsible for writing each chapter. As the pandemic has exemplified the need for rapid evidence generation using existing data sources, it has also emphasized the importance of careful design and methodological approaches to support causal inferences in RWD studies that can guide clinical and regulatory decision. The Editorial Committee hopes that this primer can provide introductory level insight in core pharmacoepidemiologic methods for RWE study conduct. The committee would like to express its gratitude to all chapter authors and Karen Staman and Amy Bokser for editorial support.
The Editorial Committee
| Alecia Clary, PhD, MSW1 | Donna R. Rivera, PharmD, FISPE, MSc2,7 |
| Joy C. Eckert, MPH1 | Carla Rodriguez-Watson, PhD, MPH1 |
| Joshua J. Gagne, PharmD, ScD2,3,4 | Almut G. Winterstein, RPh, PhD, FISPE2,8 |
| Christopher T. Rentsch, PhD, MPH2,5,6 |
Affiliations:
1Reagan-Udall Foundation for the FDA
2Real-World Evidence Task Force, International Society for Pharmacoepidemiology
3Johnson & Johnson Epidemiology
4Department of Epidemiology, Harvard T.H. Chan School of Public Health
5Faculty of Epidemiology and Population Health, London School of Hygiene & Tropical Medicine
6Department of Internal Medicine, Yale School of Medicine
7Oncology Center for Excellence, U.S. Food and Drug Administration
8Department of Pharmaceutical Outcomes and Policy and Center for Drug Evaluation and Safety, University of Florida
Disclosure:
This activity is a project of the COVID-19 Evidence Accelerator which is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of an award of $570,206 in federal funds (100% of the project). This publication reflects the view of the authors and does not necessarily represent official views or policies of the FDA, Department of Health and Human Services, or federal government. For more information, please visit FDA.gov.