Trials stopped early for benefit Not so fast! 英文参考文献.docVIP

Available online at /content/11/1/305 Evidence-Based Medicine Journal Club EBM Journal Club Section Editor: Eric B. Milbrandt, MD, MPH Journal club critique Trials stopped early for benefit? Not so fast! Alan C. Heffner 1 , Eric B. Milbrandt 2 , and Ramesh Venkataraman 2 1 Clinical Fellow, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA Assistant Professor, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA 2 Published online: 22 February 2007 Critical Care 2007, 11: 305 (DOI 101186/cc5676) This article is online at /content/11/1/305 ? 2007 BioMed Central Ltd Expanded Abstract Citation boundaries, and adjustment procedures for interim analyses and early stopping. Montori VM, Devereaux PJ, Adhikari NK, Burns KE, Eggert CH, Briel M, Lacchetti C, Leung TW, Darling E, Bryant DM, Bucher HC, Schunemann HJ, Meade MO, Cook DJ, Erwin PJ, Sood A, Sood R, Lo B, Thompson CA, Zhou Q, Mills E, Guyatt GH: Randomized trials stopped early for benefit: a Data synthesis: Of 143 RCTs stopped early for benefit, the majority (92) were published in 5 high-impact medical journals. Typically, these were industry-funded drug trials in cardiology, cancer, and human immunodeficiency virus/AIDS. The proportion of all RCTs published in high- systematic review. JAMA 2005, 294:2203-2209 [1]. impact journals that were stopped early for benefit increased from 0.5% in 1990-1994 to 1.2% in 2000-2004 (P.001 for trend). On average, RCTs recruited 63% (SD, 25%) of the planned sample and stopped after a median of 13 (interquartile range [IQR], 3-25) months of follow-up, 1 interim analysis, and when a median of 66 (IQR, 23-195) patients had experienced the end point driving study termination (event). The median risk ratio among truncated RCTs was 0.53 (IQR, 0.28-0.66). One hundred t