Departures from the protocol during conduct of a clinical trial: a pattern from the data record consistent with a learning curve
Taekman, J. M × Stafford-Smith, M Velazquez, E. J Wright, M. C Phillips-Bute, B. G Pfeffer, M. A Sellers, M. A Pieper, K. S Newman, M. F Van de Werf, Frans Diaz, R Leimberger, J Califf, R. M #
BMJ Pub. Group
Quality & Safety in Health Care vol:19 issue:5 pages:405-410
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".