Real-world Evidence in Support of Oncology Product Registration: A Systematic Review of New Drug Application and Biologics License Application Approvals from 2015-2020
Clinical Cancer Research, 2021
Analysis Group, in collaboration with Pfizer and the Dana-Farber Cancer Institute, has published research distilling US Food and Drug Administration (FDA) commentary on the use of real-world evidence (RWE) in successful oncology product approvals between 2015 and 2020. The analysis is the first of its kind to systematically aggregate detailed regulatory feedback to provide practical insights to drug developers.
While existing FDA guidance documents provide a theoretical framework for conducting regulatory RWE studies, the details of how to actually design and analyze adequate real-world studies remain largely unaddressed. To meet this critical knowledge gap, the researchers, including Analysis Group Managing Principal Mei Sheng Duh, M.P.H., Sc.D., and Vice President Maral DerSarkissian, Ph.D., studied original and supplemental oncology new drug application and biologics license application approvals to identify the attributes of a successful RWE study that contributes to an accelerated or full drug approval. Drug developers may draw on the study’s insights to prepare stronger submission dossiers.
The analysis, “Real-world Evidence in Support of Oncology Product Registration: A Systematic Review of New Drug Application and Biologics License Application Approvals from 2015-2020,” was published in Clinical Cancer Research. Funding for the study was provided by Pfizer.
Read more at Pink Sheet (paywall)
Authors
Arondekar B, Duh MS, Bhak R, DerSarkissian M, Huynh L, Wang K, Wojciehowski J, Wu M, Wornson B, Niyazov A, Demetri G