Departures from the protocol during conduct of a clinical trial: a pattern from the data record consistent with a learning curve
Taekman J, Stafford-Smith M, Velazquez E, Wright M, Phillips-Bute B, Pfeffer M, Sellers M, Pieper K, Newman M, Van de Werf F, Diaz R, Leimberger J, Califf R. Departures from the protocol during conduct of a clinical trial: a pattern from the data record consistent with a learning curve. BMJ Quality & Safety 2010, 19: 405. PMID: 20702441, PMCID: PMC3258507, DOI: 10.1136/qshc.2008.028605.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionMyocardial infarctionClinical trial researchLearning curvePatient rankMulticentre trialSlow enrollmentAcademic research organizationsPatient deathClinical trialsPatientsTrial conductTrial researchClinical researchPatient safetyPatient ordersTrialsInfarctionValsartanFirst yearDeathRecruitment ratesSimilar patternStart dateSafety