Influence of adaptive analysis on unnecessary patient recruitment: Reanalysis of the RATPAC trial

Annals of Emergency Medicine

Volumn 60, Issue 4, 2012, Pages

  Sutton, Laura ^a,b   Julious, Steven A ^b   Goodacre, Steve W ^b  

^a UNIVERSITY OF LIVERPOOL   (United Kingdom)

^b UNIVERSITY OF SHEFFIELD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ADAPTIVE ANALYSIS; ANALYSIS; ARTICLE; CLINICAL TRIAL (TOPIC); COST CONTROL; COST EFFECTIVENESS ANALYSIS; HOSPITAL INFORMATION SYSTEM; HUMAN; PATIENT CARE; PRIORITY JOURNAL;

EID: 84866729295     PISSN: 01960644     EISSN: 10976760     Source Type: Journal    
DOI: 10.1016/j.annemergmed.2012.03.032     Document Type: Article

References (16)

1. Food and Drug Administration Guidance for industry: adaptive design clinical trials for drugs and biologics http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM201790.pdf 2010 Accessed February 17, 2012
2. M. Chang Adaptive Design Theory and Implementation Using SAS and R 2008 Chapman & Hall London, England
3. S.W. Goodacre, M. Bradburn, E. Cross The Randomised Assessment of Treatment Using Panel Assay of Cardiac Markers (RATPAC) trial: a randomised controlled trial of point-of-care cardiac markers in the emergency department Heart 97 2011 190 196
4. C. Jennison, B.W. Turnbull Group Sequential Methods With Applications to Clinical Trials 2000 Chapman & Hall New York, NY
5. S. Chow, M. Chang Adaptive design methods in clinical trials - a review Orphanet J Rare Dis 3 2008 11 http://www.ojrd.com/content/pdf/1750-1172-3-11.pdf Accessed April 23, 2012
6. J. Whitehead The Design and Analysis of Sequential Clinical Trials 2nd ed. 1997 Wiley Chichester, England
7. J. Whitehead, I. Stratton Group sequential clinical trials with triangular continuation regions Biometrics 39 1983 227 236
8. MPS Research Unit PEST 4: Operating Manual 2000 University of Reading Reading, England
9. R Development Core Team R: A Language and Environment for Statistical Computing 2011 R Foundation for Statistical Computing Vienna, Austria http://www.R-project.org Accessed January 1, 2012
10. P. Fitzgerald, S.W. Goodacre, E. Cross Cost-effectiveness of point-of-care biomarker assessment for suspected myocardial infarction: the Randomised Assessment of Treatment Using Panel Assay of Cardiac Markers (RATPAC) trial Acad Emerg Med 18 2011 488 495
11. S. Pocock, I. White Trials stopped early: too good to be true? Lancet 353 1999 943 944
12. M. Bradburn, S.W. Goodacre, P. Fitzgerald et al. Inter-hospital variation in the RATPAC trial (Randomised Assessment of Treatment using Panel Assay of cardiac markers) Emerg Med J 29 2012 233 238
13. B. Freidlin, E.L. Korn Stopping clinical trials early for benefit: impact on estimation Clin Trials 6 2009 119 125
14. A.N. Donaldson, J. Whitehead, R. Stephens A simulated sequential analysis based on data from two MRC trials Br J Cancer 68 1993 1171 1178
15. G.L. Rosner, A.A. Tsiatis The impact that group sequential tests would have made on ECOG clinical trials Statist Med 8 1989 505 516
16. R.J. Lewis, H.A. Bessen Sequential clinical trials in emergency medicine Ann Emerg Med 19 1990 1047 1053