Challenges and Opportunities in Developing an Oncology Clinical Trial Network in the United States Veterans Affairs Health Care System: The VA STARPORT Experience
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.
Authors
- James S. Welsh (ORCID: https://orcid.org/0000-0002-3255-6412)
- Hann‐Hsiang Chao (ORCID: https://orcid.org/0000-0003-1096-0884)
- Yu-Ning Wong
- Kevin Zheng (ORCID: https://orcid.org/0000-0003-4654-1809)
- Ryan F. Leparski
- Abhishek A. Solanki (ORCID: https://orcid.org/0000-0002-7762-8205)
- Aryavarta M. S. Kumar (ORCID: https://orcid.org/0000-0002-3621-4962)
- Matthew B. Rettig (ORCID: https://orcid.org/0000-0002-7394-3056)
- Marcus Lee Quek (ORCID: https://orcid.org/0000-0002-6301-3955)
- Lisa Robin
- William C. Stross (ORCID: https://orcid.org/0000-0002-3474-5866)
- Rhonda L. Bitting (ORCID: https://orcid.org/0000-0002-5253-0551)
- Nicholas G. Nickols (ORCID: https://orcid.org/0000-0002-3131-9212)
- Joseph Kamel Salama (ORCID: https://orcid.org/0000-0001-5159-4687)
- Elizabeth Henry (ORCID: https://orcid.org/0000-0003-2948-3985)
- Lindsay Puckett (ORCID: https://orcid.org/0000-0003-2058-6953)
- Kimberly Carlson (ORCID: https://orcid.org/0000-0003-2022-8750)
- Alicia Skipworth
- Albert C. Chen (ORCID: https://orcid.org/0000-0002-0953-3992)
- Ronald Shapiro
- Jeffrey A. Jones
- Timothy Ritter
- Michael Chang
- Alec M. Block
- Robert Kwon
Institutions
- Michael E. DeBakey VA Medical Center (US)
- Loyola University Chicago (US)
- Hunter Holmes McGuire VA Medical Center (US)
- Edward Hines, Jr. VA Hospital (US)
- VA Connecticut Healthcare System (US)
- Milwaukee VA Medical Center (US)
- Richard L. Roudebush VA Medical Center (US)
- Louis Stokes Cleveland VA Medical Center (US)
- Philadelphia VA Medical Center (US)
- Durham VA Medical Center (US)
- Minneapolis VA Medical Center (US)
- VA Long Beach Healthcare System (US)
- VA Greater Los Angeles Healthcare System (US)
- Indiana University – Purdue University Indianapolis (US)
Publication Details
- Journal
- Current Oncology
- Published
- 2024-08-21
- DOI
- https://doi.org/10.3390/curroncol31080358
- Citations
- 1
- Primary Topic
- Ethics in Clinical Research
- Type
- article
- Field-Weighted Citation Impact
- 0.54
Funders
- U.S. Department of Veterans Affairs
- Clinical Science Research and Development