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...
| Publicado en: | Current Oncology Vol. 31; no. 8; pp. 4781 - 4795 |
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| Autores principales: | , , , , , , , , , , , , , , , , , , , |
| Formato: | Journal Article |
| Publicado: |
MDPI
Aug2024
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=179352189&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 179352189 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 11980052 5EKK jtl: Current Oncology issn: 11980052 maglogo: N pubinfo: dt: Aug2024 vid: 31 iid: 8 pid: 97109 pub: MDPI artinfo: ui: 179352189 10.3390/curroncol31080358 179352189 ppf: 4781 ppct: 14 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: Challenges and Opportunities in Developing an Oncology Clinical Trial Network in the United States Veterans Affairs Health Care System: The VA STARPORT Experience. aug: au: Solanki, Abhishek A. Zheng, Kevin Skipworth, Alicia N. Robin, Lisa M. Leparski, Ryan F. Henry, Elizabeth Rettig, Matthew Salama, Joseph K. Ritter, Timothy Jones, Jeffrey Quek, Marcus Chang, Michael Block, Alec M. Welsh, James S. Kumar, Aryavarta Chao, Hann-Hsiang Chen, Albert C. Shapiro, Ronald Bitting, Rhonda L. Kwon, Robert affil: Edward Hines Jr. VA Hospital, Hines, IL 60141, USA sug: ab: 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. pubtype: Academic Journal doctype: Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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