Oncology Value Coalition: The Evolution of Clinical Research—Expedited Pathways, RWE, and Decentralized Trials, Part 1

In the latest Oncology Value Coalition from The American Journal of Managed Care®, Bruce Feinberg, DO, led a discussion on how the traditional one-size-fits-all clinical development and regulatory approval paradigm has evolved to become an increasingly customizable process.

Precision medicine is redefining how we evaluate and treat disease. Cancer is no longer defined by organ, tissue, or cell type but rather by genotype.

Conducting traditional 3-phased clinical trials in orphan disease categories on a myriad of novel therapeutics, while trying to expedite therapies from lab bench to bedside is forcing a transformation of both the clinical development and regulatory process. From cohort expansion to accelerated pathways to decentralized trials, this transformation has placed real-world evidence at the center of the approval process.

In the latest Oncology Value Coalition from The American Journal of Managed Care®, panelists from Cardinal Health Specialty Solutions discuss how the traditional one-size-fits-all clinical development and regulatory approval paradigm has evolved to become an increasingly customizable process.

Bruce Feinberg, DO, chief medical officer, Cardinal Health Specialty Solutions, moderated the discussion with:

Andy Klink, PhD, MPH, Director, Lead Scientist, Real-World Evidence & Insights, Cardinal Health Specialty Solutions
Ajeet Gajra, MD, MBBS, FACP, Vice President, Chief Medical Officer, Cardinal Health Specialty Solutions
Scott Swain, PhD, MPH, Director of Real-World Evidence and Regulatory Sciences, Cardinal Health Specialty Solutions

In segment 1, the panelists discuss the evolution of drug development.