« Previous
Next »
Journal of Clinical Epidemiology
Volume 63, Issue 4
, Pages 347-349
, April 2010
A probiotics trial on trial: the problem of timely detection of adverse advents in therapeutic trials
References
- Dutch Acute Pancreatitis Study Group. Probiotic prophylaxis in predicted severe acute pancreatitis: a randomised, double-blind, placebo-controlled trial. Lancet. 2008;371:651–659
- . Statistics, ethics, and probiotica. Statistica Neerlandica. 2009;63:1–12Available at: http://arxiv.org/abs/0804.2522v1
- . The field guide to understanding human error. Aldershot: Ashgate; 2006;
- . Hindsight bias, outcome knowledge and adaptive learning. Qual Saf Health Care. 2003;12(Suppl 2):ii46–ii50
- . Current controversies in data monitoring for clinical trials. Clin Trials. 2006;3:513–521
- . Early stopping of randomized clinical trials for overt efficacy is problematic. J Clin Epidemiol. 2008;61:241–246
- . Bayesian clinical trials. Nat Rev Drug Discov. 2006;5:27–36
- . Interim analyses and sequential designs in phase III studies. Br J Clin Pharmacol. 2001;51:394–399
- . Value judgments in the analysis and synthesis of evidence. J Clin Epidemiol. 2008;61:521–524
- . Dutch Acute Pancreatitis Study Group. Probiotic prophylaxis in patients with predicted severe acute pancreatitis (PROPATRIA): design and rationale of a double-blind, placebo-controlled randomised multicenter trial [ISRCTN38327949]. BMC Surg. 2004;4:12
- . The simplest statistical test: how to check for a difference between treatments. BMJ. 2006;332:1256–1258
- . P-Values and confidence intervals: two sides of the same unsatisfactory coin. J Clin Epidemiol. 1998;51:355–360
- . Confronting therapeutic ignorance. BMJ. 2008;337:246–247
- . Leaping to conclusions. BMJ. 2008;336:1213–1214
- . The rise of litigation in human subjects research. Ann Intern Med. 2003;139:40–45
- . How to make good decisions. Acta Psychol. 1984;56:5–27
- Liability issues for data monitoring committee members. Clin Trials. 2004;1:525–531
- . 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;161:595–603
- . Is Bayesian analysis ready for use in phase III randomized clinical trials? Beware the sound of the sirens. Stroke. 2005;36:6122–6123
PII: S0895-4356(09)00210-8
doi: 10.1016/j.jclinepi.2008.12.012
© 2010 Elsevier Inc. All rights reserved.
« Previous
Next »
Journal of Clinical Epidemiology
Volume 63, Issue 4
, Pages 347-349
, April 2010
