Permutation criteria to evaluate multiple clinical endpoints in a proof-of-concept study: Lessons from Pre-RELAX-AHF

Clinical Research in Cardiology

Volumn 100, Issue 9, 2011, Pages 745-753

  Davison, Beth A ^a   Cotter, Gad ^a   Sun, Hengrui ^a   Chen, Li ^b   Teerlink, John R ^c   Metra, Marco ^d   Felker, G Michael ^e   Voors, Adriaan A ^f   Ponikowski, Piotr ^g   Filippatos, Gerasimos ^h   Greenberg, Barry ⁱ   Teichman, Sam L ^j   Unemori, Elaine ^j   Koch, Gary G ^b  

^a Momentum Research Inc   (United States)

^b University of North Carolina at Chapel Hill   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d UNIVERSITY OF BRESCIA   (Italy)

^e DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^f UNIVERSITY MEDICAL CENTER GRONINGEN   (Netherlands)

^g WROCLAW MEDICAL UNIVERSITY   (Poland)

^h UNIVERSITY OF ATHENS   (Greece)

ⁱ UNIVERSITY OF CALIFORNIA   (United States)

^j NONE   (United States)

more..

Author keywords

Clinical trials; Heart failure; Phase II; Statistics

Indexed keywords

RELAXIN;

ACUTE HEART FAILURE; ARTICLE; CONTINUOUS INFUSION; CORRELATION ANALYSIS; DATA ANALYSIS; DRUG DOSE COMPARISON; DRUG EFFECT; EVALUATION; HUMAN; MAJOR CLINICAL STUDY; METHODOLOGY; OUTCOME ASSESSMENT; OUTCOMES RESEARCH; PERMUTATION CRITERION; PROBABILITY; PROOF OF CONCEPT STUDY; QUANTITATIVE ANALYSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RETROSPECTIVE STUDY; STATISTICAL ANALYSIS;

ACUTE DISEASE; DOSE-RESPONSE RELATIONSHIP, DRUG; ENDPOINT DETERMINATION; HEART FAILURE; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RELAXIN; RETROSPECTIVE STUDIES; TREATMENT OUTCOME;

EID: 80054771951     PISSN: 18610684     EISSN: 18610692     Source Type: Journal    
DOI: 10.1007/s00392-011-0304-5     Document Type: Article

References (18)

1. M Gheorghiade PS Pang 2009 Are BNP changes during hospitalization for heart failure a reliable surrogate for predicting the effects of therapies on post-discharge mortality? J Am Coll Cardiol 53 25 2349 2352 19539145 10.1016/j.jacc.2009.01.075 1:CAS:528:DC%2BD1MXovFShtLs%3D
2. LS Maier M Baumhakel M Bohm 2009 Hotline sessions presented at the American College of Cardiology Congress 2009 Clin Res Cardiol 98 6 345 352 19430713 10.1007/s00392-009-0023-3
3. JR Teerlink M Metra GM Felker P Ponikowski AA Voors BD Weatherley, et al. 2009 Relaxin for the treatment of patients with acute heart failure (Pre-RELAX-AHF): a multicentre, randomised, placebo-controlled, parallel-group, dose-finding phase IIb study Lancet 373 9673 1429 1439 19329178 10.1016/S0140-6736(09)60622-X 1:CAS:528:DC%2BD1MXltVCqtbk%3D
4. JA Franciosa AL Taylor JN Cohn CW Yancy S Ziesche A Olukotun, et al. 2002 African-American Heart Failure Trial (A-HeFT): rationale, design, and methodology J Card Fail 8 3 128 135 12140804 10.1054/jcaf.2002.124730 (Pubitemid 34857277)
5. GM Felker KJ Anstrom JG Rogers 2008 A global ranking approach to end points in trials of mechanical circulatory support devices J Card Fail 14 5 368 372 18514927 10.1016/j.cardfail.2008.01.009 (Pubitemid 351749834)
6. LA Allen AF Hernandez CM O'Connor GM Felker 2009 End points for clinical trials in acute heart failure syndromes J Am Coll Cardiol 53 24 2248 2258 19520247 10.1016/j.jacc.2008.12.079
7. JG Cleland N Freemantle AP Coletta AL Clark 2006 Clinical trials update from the American Heart Association: REPAIR-AMI, ASTAMI, JELIS, MEGA, REVIVE-II, SURVIVE, and PROACTIVE Eur J Heart Fail 8 1 105 110 16387630 10.1016/j.ejheart.2005.12.003 1:CAS:528:DC%2BD28XkvFWn (Pubitemid 43012109)
8. G Cotter HC Dittrich BD Weatherley DM Bloomfield CM O'Connor M Metra, et al. 2008 The PROTECT pilot study: a randomized, placebo-controlled, dose-finding study of the adenosine A1 receptor antagonist rolofylline in patients with acute heart failure and renal impairment J Card Fail 14 8 631 640 18926433 10.1016/j.cardfail.2008.08.010 1:CAS:528:DC%2BD1cXhtFOrtLvK
9. BM Massie CM O'Connor M Metra P Ponikowski JR Teerlink G Cotter, et al. 2010 Rolofylline, an adenosine A1-receptor antagonist, in acute heart failure N Engl J Med 363 15 1419 1428 20925544 10.1056/NEJMoa0912613
10. RJ Hajjar K Zsebo L Deckelbaum C Thompson J Rudy A Yaroshinsky, et al. 2008 Design of a phase 1/2 trial of intracoronary administration of AAV1/SERCA2a in patients with heart failure J Card Fail 14 5 355 367 18514926 10.1016/j.cardfail.2008.02.005 1:CAS:528:DC%2BD1cXms1Wksrw%3D (Pubitemid 351756538)
11. PC O'Brien 1984 Procedures for comparing samples with multiple endpoints Biometrics 40 4 1079 1087 6534410 10.2307/2531158
12. W Lehmacher G Wassmer P Reitmeir 1991 Procedures for two-sample comparisons with multiple endpoints controlling the experimentwise error rate Biometrics 47 2 511 521 1912258 10.2307/2532142 1:STN:280:DyaK38%2FgtlWjuw%3D%3D
13. AF Hernandez CB Granger 2009 Advancing care for acute heart failure-no time to relax Lancet 373 9673 1401 1402 19329180 10.1016/S0140-6736(09)60653-X
14. SP Anand SC Murray GG Koch 2010 Sample size calculations for crossover thorough QT studies: satisfaction of regulatory threshold and assay sensitivity J Biopharm Stat 20 3 587 603 20358438 10.1080/10543400903582000
15. GM Felker PS Pang KF Adams JG Cleland G Cotter K Dickstein, et al. 2010 Clinical trials of pharmacological therapies in acute heart failure syndromes: lessons learned and directions forward Circ Heart Fail 3 2 314 325 20233993 10.1161/CIRCHEARTFAILURE.109.893222
16. G Cotter AA Voors BD Weatherley PS Pang JR Teerlink G Filippatos, et al. 2010 Acute heart failure clinical drug development: from planning to proof of activity to Phase III Cardiology 116 4 292 301 20881385 10.1159/000318048
17. DT Felson JJ Anderson M Boers C Bombardier M Chernoff B Fried, et al. 1993 The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. The Committee on Outcome Measures in Rheumatoid Arthritis Clinical Trials Arthritis Rheum 36 6 729 740 8507213 10.1002/art.1780360601 1:STN:280:DyaK3s3ot1ylsQ%3D%3D (Pubitemid 23175613)
18. Cohen J (1988) Statistical power analysis for the behavioral sciences, 2nd edn. Lawrence Erlbaum Associates, Inc., Hillsdale