title: Department of Veterans Affairs Cooperative Studies Program Network of Dedicated Enrollment Sites: Implications for Surgical Trials.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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
  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.affiliation: 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.
authors.forename: Faisal G
authors.initials: FG
authors.lastname: Bakaeen
authors.affiliation: Hines Cooperative Studies Program Coordinating Center, Hines, Illinois.
authors.forename: Domenic J
authors.initials: DJ
authors.lastname: Reda
authors.affiliation: Department of Health Evidence and Policy, Mount Sinai School of Medicine, New York, New York.
authors.forename: Annetine C
authors.initials: AC
authors.lastname: Gelijns
authors.affiliation: Operative Care Line, Michael E. DeBakey VA Medical Center, Department of Surgery, Baylor College of Medicine, Houston, Texas.
authors.forename: Lorraine
authors.initials: L
authors.lastname: Cornwell
authors.affiliation: Operative Care Line, Michael E. DeBakey VA Medical Center, Department of Surgery, Baylor College of Medicine, Houston, Texas.
authors.forename: Shuab
authors.initials: S
authors.lastname: Omer
authors.affiliation: Mental Health Care Line, Michael E. DeBakey VA Medical Center, Houston, Texas.
authors.forename: Rayan
authors.initials: R
authors.lastname: Al Jurdi
authors.affiliation: Operative Care Line, Michael E. DeBakey VA Medical Center, Department of Surgery, Baylor College of Medicine, Houston, Texas.
authors.forename: Panos
authors.initials: P
authors.lastname: Kougias
authors.affiliation: Operative Care Line, Michael E. DeBakey VA Medical Center, Department of Surgery, Baylor College of Medicine, Houston, Texas.
authors.forename: Daniel
authors.initials: D
authors.lastname: Anaya
authors.affiliation: Operative Care Line, Michael E. DeBakey VA Medical Center, Department of Surgery, Baylor College of Medicine, Houston, Texas.
authors.forename: David H
authors.initials: DH
authors.lastname: Berger
authors.affiliation: Cooperative Studies Program Central Office, US Department of Veterans Affairs, Washington, DC.
authors.forename: Grant D
authors.initials: GD
authors.lastname: Huang
mesh_terms: D026683:Advisory Committees; D002986:Clinical Trials as Topic; D057186:Comparative Effectiveness Research; D003299:Cooperative Behavior; D006801:Humans; D018579:Patient Selection; D010865:Pilot Projects; D015397:Program Evaluation; D012107:Research Design; D013514:Surgical Procedures, Operative; D014481:United States; D014493:United States Department of Veterans Affairs