Departures from the protocol during conduct of a clinical trial: a pattern from the data record consistent with a learning curve

Taekman, JM; Stafford-Smith, M; Velazquez, EJ; Wright, MC; Phillips-Bute, BG; Pfeffer, MA; Sellers, MA; Pieper, KS; Newman, MF; Van de Werf, Frans; Diaz, R; Leimberger, J; Califf, RM

doi:10.1136/qshc.2008.028605

Departures from the protocol during conduct of a clinical trial: a pattern from the data record consistent with a learning curve

Author:

Taekman, JM

Stafford-Smith, M ; Velazquez, EJ ; Wright, MC ; Phillips-Bute, BG ; Pfeffer, MA ; Sellers, MA ; Pieper, KS ; Newman, MF ; Van de Werf, Frans ; Diaz, R ; Leimberger, J ; Califf, RM

Keywords:

performance, competence, simulation, industry, Science & Technology, Life Sciences & Biomedicine, Health Care Sciences & Services, PERFORMANCE, COMPETENCE, SIMULATION, INDUSTRY, Clinical Protocols, Guideline Adherence, Humans, Learning Curve, Multicenter Studies as Topic, Randomized Controlled Trials as Topic, Retrospective Studies, 1103 Clinical Sciences, 1117 Public Health and Health Services, 1302 Curriculum and Pedagogy, Health Policy & Services

Abstract:

Objective Recognition of learning curves in medical skill acquisition has enhanced patient safety through improved training techniques. Clinical trials research has not been similarly scrutinised. The VALsartan In Acute myocardial iNfarcTion, a large multinational, pragmatic, randomised, double-blind, multicentre trial, was retrospectively evaluated for evidence of research conduct consistent with a performance "learning curve".