TY - JOUR
T1 - Challenges and lessons learned in conducting comparative-effectiveness trials
AU - Herrick, Linda M.
AU - Locke, G. Richard
AU - Zinsmeister, Alan R.
AU - Talley, Nicholas J.
N1 - Copyright:
Copyright 2012 Elsevier B.V., All rights reserved.
PY - 2012/5
Y1 - 2012/5
N2 - The current health-care environment is demanding evidence-based medicine that relies on clinical trials as the basis for decisions. Clinician investigators are more often finding that they are personally responsible for coordinating large, multisite trials. We present strategies for successful implementation and management of multisite clinical trials and knowledge gained through an international, multisite randomized clinical trial. Topics include team composition, regulatory requirements, study organization and governance, communication strategies, recruitment and retention efforts, budget, technology transfer, and publication.
AB - The current health-care environment is demanding evidence-based medicine that relies on clinical trials as the basis for decisions. Clinician investigators are more often finding that they are personally responsible for coordinating large, multisite trials. We present strategies for successful implementation and management of multisite clinical trials and knowledge gained through an international, multisite randomized clinical trial. Topics include team composition, regulatory requirements, study organization and governance, communication strategies, recruitment and retention efforts, budget, technology transfer, and publication.
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U2 - 10.1038/ajg.2011.475
DO - 10.1038/ajg.2011.475
M3 - Review article
C2 - 22552235
AN - SCOPUS:84862305307
SN - 0002-9270
VL - 107
SP - 644
EP - 649
JO - American Journal of Gastroenterology
JF - American Journal of Gastroenterology
IS - 5
ER -