title: Coordinating and monitoring multisite clinical trials that combine pharmacological and behavioral treatments.
abstract: OBJECTIVE
  Coordination of a large, multicenter Phase 3 clinical trial is critical to the success of the trial. The focus of this article is to describe the special challenges involved in the coordination of the 11 clinical centers conducting the COMBINE clinical trial and to discuss the challenges of monitoring the information collected on the 1,383 participants enrolled in this trial.
  
  
  METHODS
  The role of the coordinating center in working with the clinical sites is to ensure both high data quality and that the intervention protocol is conducted with appropriate attention paid to patient safety and consistency across sites. To satisfy those goals, a research committee of investigators and coordinating center staff was formed. The committee monitored adverse event reporting, participant safety, recruitment, delivery of the interventions, collection of assessments and completeness and timeliness of transfer of data to the coordinating center. Objective measures of performance were determined for each criterion to provide the principal investigators, study sponsor and Data and Safety Monitoring Board with feedback on conduct of the trial. Site performance as defined by these criteria was evaluated periodically, with both detailed written and verbal feedback provided to each investigator and study coordinator.
  
  
  RESULTS
  The system was successful in detecting sites with performance issues, providing feedback to site personnel and measuring improvement. Study leadership, clinical center staff and coordinating center staff felt that the procedures for identifying and solving performance issues worked well and improved overall performance.
  
  
  CONCLUSIONS
  Establishing an organizational structure that provided (1) leadership, (2) a venue for communication, (3) performance criteria and (4) a process for monitoring performance goals and providing feedback has enabled COMBINE to achieve success in reaching these markers of clinical trial practice.
authors.affiliation: Collaborative Studies Coordinating Center, University of North Carolina at Chapel Hill, 13 7 East Franklin Street, Suite 203, Chapel Hill, North Carolina 27514, USA. myoungblood@mail.cscc.unc.edu
authors.forename: Marston E
authors.initials: ME
authors.lastname: Youngblood
authors.forename: Kelly T
authors.initials: KT
authors.lastname: Murray
authors.forename: Eric
authors.initials: E
authors.lastname: Devine
authors.forename: Patricia K
authors.initials: PK
authors.lastname: Latham
authors.forename: Sandra
authors.initials: S
authors.lastname: Hubatch
mesh_terms: D000437:Alcoholism / Q000188:drug therapy / Q000628:therapy*; D001521:Behavior Therapy / Q000379:methods*; D035843:Biomedical Research / Q000379:methods; D002568:Certification / Q000592:standards; D002986:Clinical Trials as Topic / Q000592:standards*; D003131:Combined Modality Therapy; D004358:Drug Therapy / Q000379:methods*; D006282:Health Personnel / Q000193:education / Q000592:standards; D006801:Humans; D015337:Multicenter Studies as Topic / Q000592:standards*