Faculty Collaboration Database

Challenges and Opportunities in Developing an Oncology Clinical Trial Network in the United States Veterans Affairs Health Care System: The VA STARPORT Experience. Curr Oncol 2024 Aug 21;31(8):4781-4794

Date

08/28/2024

Pubmed ID

39195341

Pubmed Central ID

PMC11353739

DOI

10.3390/curroncol31080358

Scopus ID

2-s2.0-85202618048 (requires institutional sign-in at Scopus site)

Abstract

The United States Veterans Affairs (VA) Health Care System has a strong history of conducting impactful oncology randomized clinical trials (RCTs). We developed a phase II/III RCT to test the use of metastasis-directed therapy in Veterans with oligometastatic prostate cancer (OMPC)-the first VA RCT in OMPC that leverages novel imaging and advanced radiotherapy techniques. To accomplish this, we developed a clinical trial network to conduct the study. In this manuscript, we describe several challenges we encountered in study development/conduct and our strategies to address them, with the goal of helping investigators establish robust study networks to conduct clinical trials. In the study start-up, we encountered challenges in timely site activation, and leveraged project management to maximize efficiency. Additionally, there were several changes in the clinical paradigms in imaging and treatment that led to protocol amendments to ensure maximum equipoise, recruitment, and impact of the study. Specifically, we amended the trial to add de novo OMPC patients (from initially only recurrent OMPC) and expanded the study to allow up to 10 metastases (from initially five). Finally, in order to maintain local study team engagement, we developed initiatives to maximize collaboration and add value to the overall clinical program through study participation.

Author List

Solanki AA, Zheng K, Skipworth AN, Robin LM, Leparski RF, Henry E, Rettig M, Salama JK, Ritter T, Jones J, Quek M, Chang M, Block AM, Welsh JS, Kumar A, Chao HH, Chen AC, Shapiro R, Bitting RL, Kwon R, Stross W, Puckett L, Wong YN, Nickols NG, Carlson K, VA STARPORT Investigators Group

Author

Lindsay L. Puckett MD Associate Professor in the Radiation Oncology department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Clinical Trials as Topic
Humans
Male
Medical Oncology
Prostatic Neoplasms
United States
United States Department of Veterans Affairs
Veterans