Big Challenges for Small Sponsors: Competition in Oncology Research

INTRODUCTION:

Trial growth has dramatically outpaced site capacity since 2015, at the same time the number of new investigators participating in clinical trials has decreased by 48%. Those are just two reasons sponsors miss 80% of critical clinical trial milestones, and for smaller biopharma sponsors one missed milestone alone can create significant issues for a study and the company itself.
 
Every biopharma sponsor faces the challenge of initiating, running and closing trials on time, but oncology studies pose several unique hurdles:¹
  • Competition for sites and site resources is particularly fierce: In the last 10 years, the number of oncology drugs in development grew at almost twice the pace of any other therapeutic area.
  • Oncology phase 2-3 trials have a higher average number of substantial amendments and more protocol deviations.
  • Oncology trials typically involve more countries and sites yet recruit fewer participants. This reflects their focus on precision medicine as well as the difficulties of recruitment and retention.
  • Oncology protocol designs are more complex and associated with high screen- and completion-failure rates.
  • Treatment duration is typically 30%-40% longer.

Staying competitive in the oncology trial arena demands protocol optimization and specialized statistical support. It also requires selection of optimal sites, site-friendly just-in-time training, and site support to reduce the pressure on sites and relieve bottlenecks....

Access the report to continue reading.

Previous Flipbook
Q&A: A Fresh Perspective from the FDA on the Final IND Safety Reporting Rule
Q&A: A Fresh Perspective from the FDA on the Final IND Safety Reporting Rule

Next Video
A Fresh Perspective from the FDA on the Final IND Safety Reporting Rule
A Fresh Perspective from the FDA on the Final IND Safety Reporting Rule

A Fresh Perspective from the FDA on the Final IND Safety Reporting Rule

New Blog: "Ask the IRB Experts"

Visit Blog