Document Detail

A cooperative network of trained sites for the conduct of a complex clinical trial: a new concept in multicenter clinical research.
MedLine Citation:
PMID:  16442913     Owner:  NLM     Status:  MEDLINE    
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.
Robert M Davidson; J Frederick McNeer; Leanne Logan; Michael B Higginbotham; Jerome Anderson; Joseph Blackshear; Alan Chu; Bruce Hettleman; Frank McGrew; Roderick Meesse; Christopher O'Connor; Ricky Schneider; Galen S Wagner;
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  American heart journal     Volume:  151     ISSN:  1097-6744     ISO Abbreviation:  Am. Heart J.     Publication Date:  2006 Feb 
Date Detail:
Created Date:  2006-01-30     Completed Date:  2006-02-10     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0370465     Medline TA:  Am Heart J     Country:  United States    
Other Details:
Languages:  eng     Pagination:  451-6     Citation Subset:  AIM; IM    
Warren Clinics, Tulsa, OK, USA.
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MeSH Terms
Angiotensin-Converting Enzyme Inhibitors / therapeutic use
Cardiology / education
Exercise Test / economics,  instrumentation,  methods*
Feasibility Studies
Heart Failure* / drug therapy,  economics,  physiopathology
Interprofessional Relations
Multicenter Studies as Topic / methods*
Patient Selection*
Pilot Projects
Pulmonary Gas Exchange
Randomized Controlled Trials as Topic / economics,  methods*
Receptors, Angiotensin / antagonists & inhibitors
Research Personnel / education*,  organization & administration
Research Support as Topic
Societies, Medical
Reg. No./Substance:
0/Angiotensin-Converting Enzyme Inhibitors; 0/Receptors, Angiotensin

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