Faisal G Bakaeen1, Domenic J Reda2, Annetine C Gelijns3, Lorraine Cornwell4, Shuab Omer4, Rayan Al Jurdi5, Panos Kougias4, Daniel Anaya4, David H Berger4, Grant D Huang6. 1. Operative Care Line, Michael E. DeBakey VA Medical Center, Department of Surgery, Baylor College of Medicine, Houston, Texas2Department of Cardiovascular Surgery, Texas Heart Institute, Houston. 2. Hines Cooperative Studies Program Coordinating Center, Hines, Illinois. 3. Department of Health Evidence and Policy, Mount Sinai School of Medicine, New York, New York. 4. Operative Care Line, Michael E. DeBakey VA Medical Center, Department of Surgery, Baylor College of Medicine, Houston, Texas. 5. Mental Health Care Line, Michael E. DeBakey VA Medical Center, Houston, Texas. 6. Cooperative Studies Program Central Office, US Department of Veterans Affairs, Washington, DC.
Abstract
IMPORTANCE: Surgical clinical trials have played a critical role in shaping clinical practice, yet their launch and conduct remain challenging. Innovative approaches to carrying out such studies can not only help transform how trials produce definitive evidence but also move the field toward increased participation in trials. OBJECTIVE: To review a recently launched pilot program aimed at enhancing patient enrollment and improving surgical trial operations at individual sites and nationally. SETTING AND PARTICIPANTS: After a solicitation to create a national network focused on making the conduct of clinical trials more efficient, 10 Department of Veterans Affairs (VA) sites were selected. These sites, collectively called the Cooperative Studies Program (CSP) Network of Dedicated Enrollment Sites (NODES), were evaluated with regard to their previous participation in CSP multisite trials, the strength of the local clinical research environment, and presentation of innovative plans to coordinate and enhance the operations of local CSP studies and share best practices with other centers. Node accountability was also emphasized and involved metrics that tracked productivity and efficiency. RESULTS: Building from available CSP experience in a range of clinical trials, including ones involving surgical interventions, NODES provides VA surgeons with resources for facilitating timely study initiation, determining patient availability, and addressing enrollment barriers. Such resources are particularly important for surgical studies, which often face challenges in patient recruitment and retention. In addition, NODES can maintain qualified and trained personnel at sites to support surgeons with limited time to fulfill the numerous administrative and regulatory responsibilities that often fall to the investigators. CONCLUSIONS AND RELEVANCE: The VA's approach to enhancing trial efficiency may reinvigorate interest in surgical trials by offering a redesigned cooperative framework that builds on a core of high-yield sites and could mitigate traditional limitations of surgical trials.
IMPORTANCE: Surgical clinical trials have played a critical role in shaping clinical practice, yet their launch and conduct remain challenging. Innovative approaches to carrying out such studies can not only help transform how trials produce definitive evidence but also move the field toward increased participation in trials. OBJECTIVE: To review a recently launched pilot program aimed at enhancing patient enrollment and improving surgical trial operations at individual sites and nationally. SETTING AND PARTICIPANTS: After a solicitation to create a national network focused on making the conduct of clinical trials more efficient, 10 Department of Veterans Affairs (VA) sites were selected. These sites, collectively called the Cooperative Studies Program (CSP) Network of Dedicated Enrollment Sites (NODES), were evaluated with regard to their previous participation in CSP multisite trials, the strength of the local clinical research environment, and presentation of innovative plans to coordinate and enhance the operations of local CSP studies and share best practices with other centers. Node accountability was also emphasized and involved metrics that tracked productivity and efficiency. RESULTS: Building from available CSP experience in a range of clinical trials, including ones involving surgical interventions, NODES provides VA surgeons with resources for facilitating timely study initiation, determining patient availability, and addressing enrollment barriers. Such resources are particularly important for surgical studies, which often face challenges in patient recruitment and retention. In addition, NODES can maintain qualified and trained personnel at sites to support surgeons with limited time to fulfill the numerous administrative and regulatory responsibilities that often fall to the investigators. CONCLUSIONS AND RELEVANCE: The VA's approach to enhancing trial efficiency may reinvigorate interest in surgical trials by offering a redesigned cooperative framework that builds on a core of high-yield sites and could mitigate traditional limitations of surgical trials.
Authors: Danielle Beck; Aliya Asghar; Tawni Kenworthy-Heinige; Marcus R Johnson; Cyenthia Willis; Alexandra S Kantorowicz; Debra L Condon; Grant D Huang Journal: Contemp Clin Trials Commun Date: 2020-07-18
Authors: Chiamaka L Okorie; Elise Gatsby; Florian R Schroeck; A Aziz Ould Ismail; Kristine E Lynch Journal: PLoS One Date: 2022-05-13 Impact factor: 3.752
Authors: Kandi E Velarde; Jennifer M Romesser; Marcus R Johnson; Daniel O Clegg; Olga Efimova; Steven J Oostema; Jeffrey S Scehnet; Scott L DuVall; Grant D Huang Journal: Contemp Clin Trials Commun Date: 2018-07-10