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….
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