Novel sources and growing volumes of data are changing the way drugs are developed, evaluated, and brought to market. Additionally, the FDA has signaled a serious interest in understanding how data from the real world can augment traditional clinical trial models, creating new opportunities for efficiency and broader representativeness in clinical research. These two forces converged in 2019, resulting in a landmark year for the use of real-world evidence (RWE) in drug development.

While early use cases have been very promising, the absence of industry-wide data standards and a lack of clear consensus about how and when to use RWE limit widespread adoption. In 2020, we expect many of these challenges to be addressed by stakeholders across the industry as they collaborate to make drug development more efficient, ultimately getting the best drugs to patients faster and less expensively.

In the spirit of collaboration, COTA invited our partners from Pfizer and Bristol-Myers Squibb to share their unique perspectives as early adopters of RWE. We are grateful for the thoughtful contributions of Christopher Boone, PhD, Vice President and Lead for Global Medical Epidemiology and Big Data Analysis, and James HarnettPharmD, Senior Director of Global Medical Epidemiology & Big Data Shared Services Lead for Oncology and Vaccines, both from Pfizer; Tanvi Shah, the Director of Alliance Management at Bristol-Myers Squibb; and Viraj Narayanan, Vice President of Life Sciences at COTA.

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