Journal article
Effects of the end point adjudication process on the results of the perindopril protection against recurrent stroke study (PROGRESS)
T Ninomiya, G Donnan, N Anderson, C Bladin, B Chambers, G Gordon, N Sharpe, J Chalmers, M Woodward, B Neal
Stroke | LIPPINCOTT WILLIAMS & WILKINS | Published : 2009
Abstract
BACKGROUND AND PURPOSE-: End point adjudication committees (EPAC) are widely used in large-scale clinical trials to ensure the robustness of diagnosis for end points. METHODS-: The Perindopril Protection Against Recurrent Stroke Study (PROGRESS) was a double-blind randomized trial of blood pressure lowering in 6105 participants with pre-existing cerebrovascular disease. Separate estimates of the effects of randomized treatment were determined using Cox regression models that were based on the unadjudicated events initially reported by the investigator and on the final events assigned by the EPAC. RESULTS-: There were 992 strokes initially reported by the investigators and 894 (90%) retained ..
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Funding Acknowledgements
PROGRESS was funded by grants from Servier, the Health Research Council of New Zealand, and the National Health and Medical Research Council (NHMRC) of Australia. The study was designed, conducted, analyzed, and interpreted by the investigators independent of all sponsors. The conduct of the present analyses has been supported by fellowships awarded to T.N. by the Banyu Life Science Foundation, Japan, and the Foundation for High Blood Pressure Research in Australia.