A cooperative network of trained sites for the conduct of a complex clinical trial: a new concept in multicenter clinical research.
BACKGROUND
The purpose of this report is to present a model of physicians in full-time clinical practice participating as investigators in multicenter clinical trials, sponsored by a pharmaceutical or medical device company.


METHODS
This gas-exchange substudy was conducted as a pilot study to establish the feasibility of the 10-member EXERcise testing group of the Duke University Cooperative Cardiovascular Society (EXERDUCCS) consortium to perform a complex multicenter trial using cardiopulmonary exercise testing. An active interchange of information was established involving the principal investigator for the substudy, a dedicated full-time project coordinator, a medical director of the overall EXERDUCCS network site, the project coordinator for the sponsor, and all the participating EXERDUCCS investigators and coordinators.


RESULTS
The sponsor set as a goal of enrollment of 6 subjects per site, and 8 of the 10 sites met this goal. As a result of the successful enrollment and completion of the study and substudy by the EXERDUCCS sites, the sponsor subsequently increased the payment stipends to the sites to compensate for the extra work and expense incurred.


CONCLUSIONS
This cooperative experience accomplished several goals: (1) it allowed a complex clinical trial to be successfully completed in a time frame which would not have been possible using only single unconnected sites; (2) it educated the physician-investigators (and their personnel) in exercise cardiopulmonary; and (3) it prepared the sites for future clinical trials involving this methodology.
Davidson
Robert M
RM
Warren Clinics, Tulsa, OK, USA.
McNeer
J Frederick
JF
Logan
Leanne
L
Higginbotham
Michael B
MB
Anderson
Jerome
J
Blackshear
Joseph
J
Chu
Alan
A
Hettleman
Bruce
B
McGrew
Frank
F
Meesse
Roderick
R
O'Connor
Christopher
C
Schneider
Ricky
R
Wagner
Galen S
GS
D057911:Angiotensin Receptor Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use; D002309:Cardiology / Q000193:education; D005080:Exercise Test / Q000191:economics / Q000295:instrumentation / Q000379:methods*; D005240:Feasibility Studies; D006333:Heart Failure / Q000188:drug therapy / Q000191:economics / Q000503:physiopathology; D006801:Humans; D007400:Interprofessional Relations; D015337:Multicenter Studies as Topic / Q000379:methods*; D018579:Patient Selection; D010865:Pilot Projects; D011659:Pulmonary Gas Exchange; D016032:Randomized Controlled Trials as Topic / Q000191:economics / Q000379:methods*; D012108:Research Personnel / Q000193:education* / Q000458:organization & administration; D012109:Research Support as Topic; D012955:Societies, Medical; D014495:Universities
D057911:Angiotensin Receptor Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors