title: Implementation and evaluation of a central coordination office for clinical trials in a tertiary care hospital.
abstract: BACKGROUND
  Controlled clinical trials are essential tools for establishing new standards in patient care. Nevertheless, the majority of cancer patients are not treated within clinical trials. We report about a project now running for 7 years that was started in order to enhance the recruitment of patients into clinical trials, to improve trial-related quality, and to comply with the regulatory issues related to these studies.
  
  
  METHODS
  We established a Central Coordination Office (CCO) for clinical trials, an associated internal clinical trials review board, a register of active clinical trials, and a computer-based medical information system at our department.
  
  
  RESULTS
  Inpatient recruitment into clinical trials at our department improved over the last 7 years from 40% in 1997 to 70% in 2003. The internal review board approved 276 trial projects since its establishment. A clinical trials register is now in its 9th edition. Currently, 50 to 60 clinical trials in oncology/hematology are active while 10 to 20 new trials are being implemented per year. All clinical trials comply with the regulatory requirements, and trial documentation is provided in a timely manner.
  
  
  CONCLUSIONS
  The establishment of a CCO for clinical trials substantially improves and maintains patient recruitment into clinical trials and improves the quality of clinical research.
authors.affiliation: Department I of Internal Medicine, University Hospital Cologne, Germany.
authors.forename: Sven
authors.initials: S
authors.lastname: Trelle
authors.forename: Jan Oliver
authors.initials: JO
authors.lastname: Staak
authors.forename: Markus
authors.initials: M
authors.lastname: Jensen
authors.forename: Andreas
authors.initials: A
authors.lastname: Engert
authors.forename: Marcel
authors.initials: M
authors.lastname: Reiser
mesh_terms: D018849:Controlled Clinical Trials as Topic / Q000592:standards*; D019992:Databases as Topic / Q000458:organization & administration / Q000592:standards; D005069:Evaluation Studies as Topic; D005858:Germany; D006284:Health Plan Implementation / Q000458:organization & administration* / Q000592:standards; D006748:Hospital Departments; D006785:Hospitals, University; D006801:Humans; D007388:Internal Medicine; D009369:Neoplasms / Q000628:therapy*; D009934:Organization and Administration; D018579:Patient Selection; D011785:Quality Assurance, Health Care / Q000458:organization & administration / Q000592:standards; D012042:Registries / Q000592:standards; D012984:Software