Oncology Value Coalition: The Evolution of Clinical Research—Expedited Pathways, RWE, and Decentralized Trials, Part 4

In segment 4, the panelists discuss regulatory considerations for real-world evidence and real-world data.

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 2, the panelists discuss regulatory considerations for real-world evidence and real-world data.