Challenges and Opportunities in Developing an Oncology Clinical Trial Network in the United States Veterans Affairs...

Area of Science:

• Oncology
• Clinical Trials
• Urology

Background:

• The United States Veterans Affairs (VA) Health Care System has a history of conducting oncology randomized clinical trials (RCTs).
• Oligometastatic prostate cancer (OMPC) presents unique challenges in clinical trial design and execution.
• Establishing robust clinical trial networks is crucial for advancing cancer research.

Purpose of the Study:

• To describe the development and conduct of a phase II/III RCT for OMPC in Veterans.
• To outline challenges encountered during study development and implementation.
• To share strategies for establishing effective clinical trial networks.

Main Methods:

• Development of a clinical trial network within the VA.
• Implementation of a phase II/III RCT using novel imaging and advanced radiotherapy.
• Application of project management for efficient study start-up and conduct.
• Protocol amendments to adapt to evolving clinical paradigms and expand patient eligibility.

Main Results:

• Successfully established a clinical trial network for OMPC research.
• Overcame challenges in site activation through effective project management.
• Adapted the trial protocol to include de novo OMPC patients and increased metastasis count.
• Implemented initiatives to maintain local study team engagement and collaboration.

Conclusions:

• The study provides valuable insights into establishing and managing clinical trial networks for OMPC.
• Strategies employed can help investigators overcome common challenges in clinical trial development and conduct.
• The findings contribute to improving the design and impact of future oncology RCTs within the VA system.