- CONSORT Statement
- CONSORT Statement Extensions
- Evidence underpinning CONSORT
- Accrual and sample size
- Attitudes to trials
- Adverse events (Harms)
- Baseline data
- Blinding
- Compliance
- Early stopping
- Eligibility
- Follow-up
- Funding
- Generalizability
- Harms
- Intention to treat
- Interpretation
- Interventions
- Outcome reporting
- Random allocation
- Recruitment
- Statistical analysis
- Statistical methods
- Trial design issues
- Trial registration
- Uptake of CONSORT by journals
- Impact of and adherence to CONSORT
- Endorsement of CONSORT
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

