Problems in dealing with missing data and informative censoring in clinical trials

Current Controlled Trials in Cardiovascular Medicine

Volumn 3, Issue , 2002, Pages

  Shih, Weichung Joseph ^a,b  

^a UNIVERSITY OF MEDICINE AND DENTISTRY OF NEW JERSEY   (United States)

^b ROBERT WOOD JOHNSON MEDICAL SCHOOL   (United States)

Author keywords

Informative missing data; Intent to treat; Longitudinal study; Missing completely at random

Indexed keywords

ATORVASTATIN; CANDESARTAN HEXETIL; ENALAPRIL; HYDROCHLOROTHIAZIDE; NICOTINIC ACID; NIFEDIPINE; OMAPATRILAT; PIMOBENDAN; VERAPAMIL;

CLINICAL STUDY; CLINICAL TRIAL; DYSLIPIDEMIA; ESSENTIAL HYPERTENSION; EXPERIMENTAL DESIGN; HEART FAILURE; HUMAN; INFORMATION PROCESSING; PATIENT; PROCESS MONITORING; REVIEW; SENSITIVITY ANALYSIS; SIDE EFFECT; STATISTICAL ANALYSIS;

EID: 0242466086     PISSN: 14686694     EISSN: 14686694     Source Type: Journal    
DOI: 10.1186/1468-6708-3-4     Document Type: Review

References (28)

1. Zanchetti A, Omboni A: on behalf of the Italian Candesartan Study Group: Comparison of candesartan versus enalapril in essential hypertension. Am J Hypertens 2001, 14:129-134
2. McKenney JM, McCormick LS, Schaefer EJ, Black DM, Watkins ML: Effect of niacin and atorvastatin on lipoprotein subclasses in patients with atherogenic dyslipidemia. Am J Cardiol 2001, 88:270-274
3. The Pimobendan in Congestive Heart Failure (PICO) Investigators: Effect of pimobendan on exercise capacity in patients with heart failure: main results from the Pimobendan in Congestive Heart Failure (PICO) trial. Heart 1996, 76:223-231
4. Diamond JA, Krakoff LR, Goldman A, Coplan N, Gharavi A, Martin K, Goldsmith R, Henzlova MJ, Machac J, Phillip RA. Comparison of two calcium blockers on hemodynamics, left ventricular mass, and coronary vasodilatory in advanced hypertension. Am J Hypertens 2001, 14:231-240
5. Ferdinand K, Saini R, Lewin A, Yellen L, Barbosa JA, Kusgnir E: Efficacy and safety of omapatrilat with hydrochlorothiazide for the treatment of hypertension in subjects nonresponsive to hydrochlorotniazide alone. Am J Hypertens 2001, 14:788-793
6. Armitage P: The analysis of data from clinical trials. The Statistician 1979, 20:171-183
7. Schwarz D, Flamant R, Lellouch J: Clinical Trials. London: Academic Press, 1980
8. Downs JR, Clearfield M, Tyroler HA, Whitney EJ, Kruyer W, Langendorfer AL, Zagebelsky V, Weis S, Shapiro DR, Beere PA, Gotto AM: Air force/Texas coronary atherosclerosis prevention study (afcaps/texcaps): Additional perspectives on tolerability of long-term treatment with lovastatin. Am J Cardiol 2001, 87:1074-1079
9. The International Conference on Harmonization (ICH) [http://www.itpma.org/ichl.html]
10. Rubin DM: Multiple Imputation for Nonresponse in Surveys. New York: Wiley, 1987
11. Schafer JL: Analysis or Incomplete Multivariate Data, New York: Chapman and Hall, 1997
12. Saugus MA: SOLAS 2.0 for missing data analysis. Statistical Solutions, 2000 [http://www.statsoluusa.com]
13. Yuan YC: Multiple imputation for missing data: concepts and new development SAS/STAT 8.2. SAS Institute Inc. Cary, NC. 2001 [http://www.sas.com/statistics]
14. Murray GD, Findlay JG: Correcting for the bias caused by dropouts in hypertension trials. Statistics in Medicine 1988, 7:941-946
15. Wei L, Shin WJ: Partial imputation approach to analysis of repeated measurements with dependent dropouts. Statistics in Medicine 2001, 20:1197-1214
16. Diggle P, Kenward MG: Informative drop-out in longitudinal data analysis (with discussions). Applied Statistics 1994, 43:49-93
17. Wu MC, Carroll RJ: Estimation and comparison of changes in the presence of informative right censoring by modeling the censoring process. Biometrics 1988, 44:175-188
18. Schluchter MD: Methods for the analysis of informatively censored longitudinal data. Statistics in Medicine 1992, 11:1861-1870
19. Mu MC, Albert PS, Wu Bu: Adjusting for drop-out in clinical trials with repeated measures: design and analysis issues. Statistics in Medicine 2001, 20:93-108
20. Little RJA: Modeling the drop-out mechanism in repeated-measures studies. Journal of American Statistical Association 1995, 90:1112-1121
21. Gould AL: A new approach to the analysis of clinical drug trial with withdrawals. Biometrics 1980, 36:721-727
22. Lachin JM: Worst-rank score analysis with informatively missing observations in clinical trials. Controlled Clinical Trials 1999, 20:408-422
23. Misbin RI: Guidance for evaluation of new treatments for diabetes mellitus. Division of Metabolism and Endocrine Drug Products, CDER FDA. 1998
24. Shih WJ, Quan H: Testing for treatment difference with dropouts present in clinical trials - A composite approach. Statistics in Medicine 1997, 16:1225-1239
25. Cowley AJ, Weins BL, Segal R, Rich MW, Santanello, Dashbach EJ, Pitt B: Randomized comparison of losartin vs. captopril on quality of life in elderly patients with symptomatic heart failure: The losartin heart failure ELITE quality of life substudy. Quality of Life Research 2000, 9:377-384
26. Hogan J, Laird N: Model-based approaches to analyzing incomplete longitudinal and failure time data. Statistics in Medicine 1997, 16:259-272
27. Finkelstein D, Schoenfeld D: Combining mortality and longitudinal measures in clinical trials. Statistics in Medicine 1999, 18:1341-1354
28. Cochran WG: Planning and Analysis of Observational Studies. New York: Wiley, 1983