Stopping trials early

British Journal of Anaesthesia

Volumn 111, Issue 2, 2013, Pages 133-135

  Myles, P S ^a  

^a MONASH UNIVERSITY   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

APROTININ; DEXAMETHASONE;

ANESTHESIA; ANESTHESIOLOGY; CLINICAL PRACTICE; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); EDITORIAL; HUMAN; MORTALITY; OUTCOME ASSESSMENT; PATIENT CARE; PATIENT COMPLIANCE; PATIENT SAFETY; PRIORITY JOURNAL; RISK ASSESSMENT;

EID: 84880523168     PISSN: 00070912     EISSN: 14716771     Source Type: Journal    
DOI: 10.1093/bja/aet079     Document Type: Editorial

References (39)

1. Brooke BS, Meguid RA, Makary MA, Perler BA, Pronovost PJ, Pawlik TM. Improving surgical outcomes through adoption of evidence-based process measures: Intervention specific or associated with overall hospital quality? Surgery 2010; 147: 481-90
2. Emanuel EJ, Wendler D, Grady C. What makes clinical research ethical? J Am Med Assoc 2000; 283: 2701-11
3. Goodman N. Anaesthesia and evidence-based medicine. Anaesthesia 1998; 53: 353-68
4. Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: Increasing the value of clinical research for decision making in clinical and health policy. J Am Med Assoc 2003; 290: 1624-32
5. Goodman SN. Toward evidence-based medical statistics. 1: The P value fallacy. Ann Intern Med 1999; 130: 995-1004
6. Politzer G, Bourmaud G. Deductive reasoning fromuncertain conditionals. Br J Psychol 2002; 93: 345-81
7. Myles PS, Gin T. Statistical Methods for Anaesthesia and Intensive Care. London: Elsevier, 2000
8. Freiman JA, Chalmers TC, Smith H Jr, Kuebler RR. The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. Survey of 71 'negative' trials.N Engl J Med 1978; 299: 690-4
9. Gibbs NM,Weightman WM. Beyond effect size: Consideration of the minimum effect size of interest in anesthesia trials. Anesth Analg 2012; 114: 471-5
10. Lenth RV. Some practical guidelines for effective sample size determination. Am Stat 2001; 55: 187-93
11. Pua HL, Lerman J, Crawford MW, Wright JG. An evaluation of the quality of clinical trials in anesthesia. Anesthesiology 2001; 95: 1068-73
12. Hennekens CH, Demets D. The need for large-scale randomized evidence without undue emphasis on small trials, meta-analyses, or subgroup analyses. J Am Med Assoc 2009; 302: 2361-2
13. Pocock SJ. When to stop a clinical trial. Br Med J 1992; 305: 235-40
14. Korn EL, Freidlin B, Mooney M. Stopping or reporting early for positive results in randomized clinical trials: The National Cancer Institute Cooperative Group experience from 1990 to 2005. J Clin Oncol 2009; 27: 1712-21
15. Simon R. Some practical aspects of the interim monitoring of clinical trials. Stat Med 1994; 13: 1401-9
16. Montori VM, Devereaux PJ, Adhikari NK, et al. Randomized trials stopped early for benefit: A systematic review. J Am Med Assoc 2005; 294: 2203-9
17. DeMets D, Pocock S, Julian D. The agonising negative trend in monitoring of clinical trials. Lancet 1999; 354: 1983-8
18. Wheatley K, Clayton D. Be skeptical about unexpected large apparent treatment effects: The case of an MRC AML12 randomization. Control Clin Trials 2003; 24: 66-70
19. Freedman LS, Spiegelhalter DJ, Parmar MK. Thewhat, why and how of Bayesian clinical trials monitoring. Stat Med 1994; 13: 1371-83; discussion 85-9
20. Hartley AM. Adaptive blinded sample size adjustment for comparing two normal means-a mostly Bayesian approach. Pharm Stat 2012 Advance Access published on March 16, 2012, doi:10.1002/pst.538
21. Palmer CR, Shahumyan H.Implementing a decision-theoretic design in clinical trials: Why and how? Stat Med 2007; 26: 4939-57
22. Browner WS,NewmanTB. Are all significant P values created equal? The analogy between diagnostic tests and clinical research. J Am Med Assoc 1987; 257: 2459-63
23. Parmar MK, Griffiths GO, Spiegelhalter DJ, Souhami RL, Altman DG, van Der Scheuren E. Monitoring of large randomised clinical trials: A new approach with Bayesian methods. Lancet 2001; 358: 375-81
24. van Der Tweel I, van Noord PA. Early stopping in clinical trials and epidemiologic studies for 'futility': Conditional power versus sequential analysis. J Clin Epidemiol 2003; 56: 610-7
25. Abdelmalak BB, Bonilla A, Mascha EJ, et al. Dexamethasone, light anaesthesia, and tight glucose control (DeLiT) randomized controlled trial. Br J Anaesth 2013; 111: 209-21
26. Myles PS, Devereaux PJ. Pros and cons of composite endpoints in anesthesia trials. Anesthesiology 2010; 113: 776-8
27. Perneger TV. What's wrong with Bonferroni adjustments. Br Med J 1998; 316: 1236-8
28. Fergusson DA, Hebert PC, Mazer CD, et al. A comparison of aprotinin and lysine analogues in high-risk cardiac surgery. N Engl J Med 2008; 358: 2319-31
29. Yeager M, Glass D, Neff R, Brinck-Johnsen T. Epidural anesthesiaand analgesia in high-risk surgical patients. Anesthesiology 1987; 66: 729-36
30. Poldermans D, Boersma E, Bax J. The effect of bisoprolol on perioperative mortality and myocardial infarction in high-risk patients undergoing vascular surgery. N Engl J Med 1999; 341: 1788-94
31. Mashour GA, Shanks A, Tremper KK, et al. Prevention of intraoperative awareness with explicit recall in an unselected surgical population: A randomized comparative effectiveness trial. Anesthesiology 2012; 117: 717-25
32. Sedrakyan A, Treasure T, Elefteriades JA. Effect of aprotinin on clinicaloutcomesin coronaryartery bypass graft surgery: A systematic reviewand meta-analysis of randomized clinical trials. J Thorac Cardiovasc Surg 2004; 128: 442-8
33. Health Canada. Health Canada decision on Trasylol (aprotinin), 2011; September 21. Available from wwwhc-scgcca/ahc-asc/media/advisories-avis/-2011/ 2011-124-engphp (accessed 28 January 2013)
34. European Medicines Agency. Questions and answers on the review of antifibrinolytic medicines (aprotinin, aminocaproic acid and tranexamic acid), 2012. February 16. Available from http ://wwwemaeuropaeu/docs/en-GB/document- library/Referrals-document/Antifibrinolytic-medicines/WC500122924pdf (accessed 28 January 2013)
35. Hoenig JM, Heisey DM. The abuse of power: The pervasive fallacy of power calculations for data analysis. Am Stat 2001; 55: 1-6
36. Lachin JM. A review of methods for futility stopping based on conditional power. Stat Med 2005; 24: 2747-64
37. Betensky RA. Early stopping to accept H(o) based on conditional power: Approximations and comparisons. Biometrics 1997; 53: 794-806
38. Guyatt GH, Briel M, Glasziou P, Bassler D, Montori VM. Problems of stopping trials early. Br Med J 2012; 344: E3863
39. Ho AM, Dion PW, Karmakar MK, Lee A. Estimating with confidence the risk of rare adverse events, including those with observed rates of zero. Reg Anesth Pain Med 2002; 27: 207-10