Advancing Patient-centered Approaches to Oncology Studies: Exploring an Example

SUMMER 2022, THE EVIDENCE FORUM, WHITE PAPER

Summary

The number of investigational drugs targeting cancer has risen exponentially over the past two decades, however, recruiting and retaining patients for those clinical trials remains a challenge. The complexity of oncology studies and the increased focus on patient-centricity in drug development heightened interest in the use of decentralized approaches to cancer studies. The entrance of the COVID-19 pandemic exacerbated that interest due to the need to provide ongoing treatment to oncology patients.

In this paper, the authors discuss:

• The compelling benefits of a decentralized approach to oncology studies, particularly reducing the burden to patients to increase patient recruitment and retention.
• Perceived and actual challenges associated with innovative study designs, including operational complexities, regulatory and ethics concerns, and uneasiness with unfamiliar pathways.
• A case study outlining a need to conduct an investigational cancer treatment study while minimizing the risk of exposure to COVID-19 during the height of the pandemic, and how scientists implemented a patient-centered solution.

Authors

Brenda Garrison, Senior Director of Project Management, Interventional Studies
Evidera, a business of PPD, part of Thermo Fisher Scientific

Kristin Kluthe, PMP, Director Project Management, Interventional Studies
Evidera, a business of PPD, part of Thermo Fisher Scientific

Sarah Hagen, Senior Project Manager, Interventional Studies
Evidera, a business of PPD, part of Thermo Fisher Scientific

Mary Lynn Larson, Senior Project Manager, Patient Solutions
PPD, part of Thermo Fisher Scientific

Mariah Baltezegar, MBA, Vice President and Head, PPA Study Innovation, Real-World Evidence
Evidera, a business of PPD, part of Thermo Fisher Scientific