Early stopping

Baum M, Houghton J, Abrams K. Early stopping rules--clinical perspectives and ethical considerations. Stat Med 1994; 13(13-14):1459-1469.
PMID: 7973225

Buyse M. Interim analyses, stopping rules and data monitoring in clinical trials in Europe. Stat Med 1993; 12(5-6):509-520.
PMID: 8493429

Clemens F, Elbourne D, Darbyshire J, Pocock S. Data monitoring in randomized controlled trials: surveys of recent practice and policies. Clin Trials 2005; 2(1):22-33.
PMID: 16279576

DeMets DL, Pocock SJ, Julian DG. The agonising negative trend in monitoring of clinical trials. Lancet 1999; 354(9194):1983-1988.
PMID: 10622312

Fernandes RM, van der Lee JH, Offringa M. A systematic review of the reporting of Data Monitoring Committees' roles, interim analysis and early termination in pediatric clinical trials. BMC Pediatr 2009; 9:77.
PMID: 20003383 [New]

Garcia R, Benet M, Arnau C, Cobo E. Efficiency of the cross-over design: an empirical estimation. Stat Med 2004; 23(24):3773-3780.
PMID: 15580599

George SL, Li C, Berry DA, Green MR. Stopping a clinical trial early: frequentist and Bayesian approaches applied to a CALGB trial in non-small-cell lung cancer. Stat Med 1994; 13(13-14):1313-1327.
PMID: 7973212

Grant AM, Altman DG, Babiker AB, Campbell MK, Clemens FJ, Darbyshire JH, Elbourne DR, McLeer SK, Parmar MK, Pocock SJ, Spiegelhalter DJ, Sydes MR, Walker AE, Wallace SA. Issues in data monitoring and interim analysis of trials. Health Technol Assess 2005; 9(7):1-iv.
PMID: 15763038

Hillman DW, Louis TA. DSMB case study: decision making when a similar clinical trial is stopped early. Control Clin Trials 2003; 24(1):85-91.
PMID: 12559646

Kpozehouen A, Alioum A, Anglaret X, Van de PP, Chene G, Salamon R. Use of a Bayesian approach to decide when to stop a therapeutic trial: the case of a chemoprophylaxis trial in human immunodeficiency virus infection. Am J Epidemiol 2005; 161(6):595-603.
PMID: 15746476

Lievre M, Menard J, Bruckert E, Cogneau J, Delahaye F, Giral P, Leitersdorf E, Luc G, Masana L, Moulin P, Passa P, Pouchain D, Siest G. Premature discontinuation of clinical trial for reasons not related to efficacy, safety, or feasibility. BMJ 2001; 322(7286):603-605.
PMID: 11238162

Lilford RJ, Braunholtz D, Edwards S, Stevens A. Monitoring clinical trials--interim data should be publicly available. BMJ 2001; 323(7310):441-442.
PMID: 11520848

Mills E, Cooper C, Wu P, Rachlis B, Singh S, Guyatt GH. Randomized trials stopped early for harm in HIV/AIDS: a systematic survey. HIV Clin Trials 2006; 7(1):24-33.
PMID: 16684642

Mills EJ, Singh S, Singh JA, Orbinski JJ, Warren M, Upshur RE. Designing research in vulnerable populations: lessons from HIV prevention trials that stopped early. BMJ 2005; 331(7529):1403-1406.
PMID: 16339256

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 systematic review. JAMA 2005; 294(17):2203-2209.
PMID: 16264162

Pocock S, White I. Trials stopped early: too good to be true? Lancet 1999; 353(9157):943-944.
PMID: 10459899

Pocock SJ. When to stop a clinical trial. BMJ 1992; 305(6847):235-240.
PMID: 1392832

Trotta F, Apolone G, Garattini S, Tafuri G. Stopping a trial early in oncology: for patients or for industry? Ann Oncol 2008; 19(7):1347-1353.
PMID: 18304961

van dT, I, van Noord PA. Early stopping in clinical trials and epidemiologic studies for "futility": conditional power versus sequential analysis. J Clin Epidemiol 2003; 56(7):610-617.
PMID: 12921928

Walker AE, McLeer SK. Small group processes relevant to data monitoring committees in controlled clinical trials: an overview of reviews. Clin Trials 2004; 1(3):282-296.
PMID: 16279254

Whitehead J, Matsushita T. Stopping clinical trials because of treatment ineffectiveness: a comparison of a futility design with a method of stochastic curtailment. Stat Med 2003; 22(5):677-687.
PMID: 12587099

Page last edited: 23 March 2010