Tag: oncology trials

Clinical Research: Phase 1 - Phase 4

Regulatory Challenges in Global CAR-T Cell Therapy Development

When exploring the complex and rigorous regulatory landscape for CAR-T cell therapies, sponsors may encounter challenges in their efforts to bring products to market Since the historic approval of Kymriah® (tisagenlecleucel) in 2017, research on chimeric antigen receptor (CAR) T cell therapy has accelerated. There are more than 230 regenerative medicine companies in Europe and...

Clinical Research: Phase 1 - Phase 4

Adaptive Trial Designs in Early Oncology: Minimizing Risk & Accelerating Timelines

Introduction Over the past decade, significant advances have improved our understanding of the genetic and molecular mechanisms that lead to cancer. And yet, a recent review of the oncology drugs approved by the U.S. Food and Drug Administration (FDA) on the basis of response rate showed only 10 percent of these therapies demonstrate an overall...

Consulting

The Role of Adaptive Trial Designs in Early Oncology Studies: Optimizing Flexibility and Agility

Targeted therapies and immunotherapies have changed not only cancer treatment paradigms, but also historical approaches to clinical trial design, especially in early development. Traditionally, early phase oncology trials have been focused on dose optimization, toxicity, and broad response signals. However, with the growth of personalized medicine, many early phase studies also place emphasis on identifying...