title: Challenges and lessons learned in conducting comparative-effectiveness trials.
abstract: 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.
authors.affiliation: Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
authors.forename: Linda M
authors.initials: LM
authors.lastname: Herrick
authors.forename: G Richard
authors.initials: GR
authors.lastname: Locke
authors.forename: Alan R
authors.initials: AR
authors.lastname: Zinsmeister
authors.forename: Nicholas J
authors.initials: NJ
authors.lastname: Talley
mesh_terms: D057186:Comparative Effectiveness Research / Q000458:organization & administration*; D019317:Evidence-Based Medicine; D006801:Humans; D015337:Multicenter Studies as Topic / Q000331:legislation & jurisprudence; D018579:Patient Selection; D011643:Publishing; D016032:Randomized Controlled Trials as Topic / Q000331:legislation & jurisprudence; D012108:Research Personnel; D018581:Technology Transfer