Implementation and evaluation of a central coordination office for clinical trials in a tertiary care hospital.
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.
Trelle
Sven
S
Department I of Internal Medicine, University Hospital Cologne, Germany.
Staak
Jan Oliver
JO
Jensen
Markus
M
Engert
Andreas
A
Reiser
Marcel
M
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