Easily applicable multiple testing procedures to improve the interpretation of clinical trials with composite endpoints

International Journal of Cardiology

Volumn 175, Issue 1, 2014, Pages 126-132

  Schüler, Svenja ^a   Mucha, Annegret ^b   Doherty, Patrick ^c   Kieser, Meinhard ^a   Rauch, Geraldine ^a  

^a UNIVERSITY OF HEIDELBERG   (Germany)

^b UNIVERSITY OF BREMEN   (Germany)

^c UNIVERSITY OF YORK   (United Kingdom)

Author keywords

Composite endpoints; Multiple testing; Time to event

Indexed keywords

ARTICLE; CARDIOLOGY; CARDIOLOGY CLINICAL TRIAL; CLINICAL PRACTICE; CLINICAL TRIAL (TOPIC); DATA PROCESSING; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROCESS OPTIMIZATION; SAMPLE SIZE; SIMULATION; STATISTICAL ANALYSIS; BIOASSAY; HUMAN; PROCEDURES; RANDOMIZED CONTROLLED TRIAL (TOPIC); STATISTICS; STATISTICS AND NUMERICAL DATA;

ENDPOINT DETERMINATION; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SAMPLE SIZE; STATISTICS AS TOPIC;

EID: 84902546045     PISSN: 01675273     EISSN: 18741754     Source Type: Journal    
DOI: 10.1016/j.ijcard.2014.04.267     Document Type: Article

References (17)

1. K.E. Kip, K. Hollabaugh, O.C. Marroquin, and D.O. Williams The problem with composite end points in cardiovascular studies: the story of major adverse cardiac events and percutaneous coronary intervention J Am Coll Cardiol 51 2008 701 707
2. ICH E9 Guideline Statistical principles for clinical trials http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/ 09/WC500002928.pdf [1999, assessed 6 November 2013]
3. G.Y.H. Chi Some issues with composite endpoints in clinical trials Fundam Clin Pharmacol 19 2005 609 619
4. CPMP Guideline Points to consider on multiplicity issues in clinical trials http://www.tga.gov.au/pdf/euguide/ewp090899en.pdf [2002, assessed 6 November 2013]
5. P.S. Chan Keeping apples and oranges separate: reassessing clinical trials that use composite end points as their primary outcome (letter) J Am Coll Cardiol 48 2006 850
6. S.R. Rao, and D.A. Schoenfeld Survival methods Circulation 115 2007 109 113
7. R. Rauch, M. Kieser, and S. Ulrich et al. Competing time-to-event endpoints in cardiology trials - a simulation study to illustrate the importance of an adequate statistical analysis Eur J Prev Cardiol 21 2012 74 80
8. J. Beyersmann, A. Allignol, and M. Schumacher Competing risks and multistage models with R 2012 Springer 978-1-4614-2035-4
9. S. Goodman A dirty dozen: twelve p-values misconceptions Sem Hemat 45 2008 135 140
10. H.W. Cohen P values: use and misuse in medical literature Am J Hypertens 24 2011 18 23
11. The DREAM trial investigators Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomised controlled trial Lancet 363 2006 1096 1105
12. H.L. Lindholm, B. Ibsen, and B. Dahlöf et al. Cardiovascular morbidity and mortality in patients with diabetes in the losartan intervention for endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol Lancet 359 2002 1004 1010
13. The CAPRICORN investigators. Effect of carvedilol on outcome after myocardial infarction in patients with left-ventricular dysfunction: the CAPRICORN randomised trial Lancet 357 2001 1385 1390
14. P.H. Westfall, and A. Krishen Optimally weighted, fixed sequence and gatekeeping multiple testing procedures J Stat Plan Infer 99 2001 25 40
15. S. Holm A simple sequentially rejective multiple test procedure Scand J Stat 6 1979 65 70
16. R.L. Berger Multiparameter hypothesis testing and acceptance sampling Technometrics 24 1982 295 300
17. M.T. Koller, H. Raatz, and E.W. Steyerberg et al. Competing risks and the clinical community: irrelevance or ignorance? Stat Med 31 2011 1089 1097