Assessing response profiles from incomplete longitudinal clinical trial data under regulatory considerations

Journal of Biopharmaceutical Statistics

Volumn 13, Issue 2, 2003, Pages 179-190

  Mallinckrodt, Craig H ^a   Clark, W Scott ^a   Carroll, Raymond J ^b   Molenberghs, Geert ^c  

^a ELI LILLY AND COMPANY   (United States)

^b TEXAS A AND M UNIVERSITY   (United States)

^c HASSELT UNIVERSITY   (Belgium)

Author keywords

Longitudinal data; Missing data; Mixed effects models

Indexed keywords

ANALYTIC METHOD; ANALYTICAL ERROR; ARTICLE; CLINICAL TRIAL; CORRELATION ANALYSIS; DATA ANALYSIS; DECISION MAKING; DECISION SUPPORT SYSTEM; DEPRESSION; LONGITUDINAL STUDY; MEASUREMENT; OBSERVATION; OUTCOMES RESEARCH; PRIORITY JOURNAL; STATISTICAL ANALYSIS; STATISTICAL MODEL; TIME;

CLINICAL TRIALS; DRUGS, INVESTIGATIONAL; LONGITUDINAL STUDIES;

EID: 0037273401     PISSN: 10543406     EISSN: None     Source Type: Journal    
DOI: 10.1081/BIP-120019265     Document Type: Article

References (22)

1. Cnaan, A., Laird, N. M., Slasor, P. (1997). Using the general linear mixed model to analyze unbalanced repeated measures and longitudinal data. Stat. Med. 16:2349-2380.
2. Diggle, P. J., Kenward, M. G. (1995). Informative dropout in longitudinal data analysis (with discussion). Appl. Stat. 43:49-93.
3. Diggle, P. J., Liang, K.-Y., Zeger, S. L. (1994). Analysis of Longitudinal Data. Oxford, England: Clarendon Press.
4. Gibbons, R. D., Hedeker, D., Elkin, I., Waternaux, C., Kraemer, H. C., Greenhouse, J. B., Shea, T., Imber, S., Stotsky, S. M., Watkins, J. T. (1993). Some conceptual and statistical issues in analysis of longitudinal psychiatric data. Arch. Gen. Psychiatry 50:739-750.
5. Goldstein, D. J., Mallinckrodt, C., Lu, Y., Demitrack, M. A. (2002). Duloxetine in the treatment of major depressive disorder: a double-blind clinical trial. J. Clin. Psychiatry 63:225-231.
6. Goldstein, D.J., Lu, Y., Detke, M.J., Wiltse, C., Mallinckrodt, C., Demitrack, M.A. Duloxetine vs. paroxetine in the treatment of depression. Presented at the 155th Annual Meeting of the American Psychiatry Association, Philadelphia, PA, May 2002.
7. Hamilton, M. (1960). A rating scale for depression. J. Neurol. Neurosurg. Psychiatry 23:56-62.
8. Heyting, A., Tolboom, J. T. B. M., Essers, J. G. A. (1992). Statistical handling of dropouts in longitudinal clinical trials. Stat. Med. 11:2043-2061.
9. Laird, N. M. (1988). Missing data in longitudinal studies. Stat. Med. 7:305-315.
10. Lavori, P. W. (1992). Clinical trials in psychiatry: should protocol deviation censor patient data. Neuropsychopharmacol 6:39-48.
11. Lavori, P. W., Dawson, R., Shera, D. (1995). A multiple imputation strategy for clinical trials with truncation of patient data. Stat. Med. 14:1913-1925.
12. Little, R., Rubin, D. (1987). Statistical Analysis with Missing Data. New York: John Wiley and Sons.
13. Little, R., Yau, L. (1996). Intent-to-treat analysis for longitudinal studies with drop-outs. Biometrics 52:1324-1333.
14. Littell, R. C., Milliken, G. A., Stroup, W. W., Wolfinger, R. D. (1996). The SAS System for Mixed Models., Chap. 1-10. Cary, NC: SAS Institute Inc.
15. Mallinckrodt, C. H., Clark, W. S., David, S. R. (2001a). Accounting for dropout bias using mixed-effects models. J. Biopharm. Stat. 11:9-21.
16. Mallinckrodt, C. H., Clark, W. S., David, S. R. (2001b). Type I error rates from mixed effects model repeated measures compared with fixed effects ANOVA with missing values imputed via LOCF. Drug Inf. J. 35:1215-1225.
17. Milliken, G. A., Johnson, D. E. (1993). The Analysis of Messy Data: Designed Experiments. Vol. 1. New York: Chapman & Hall, 326.
18. Molenberghs, G., Thijs, H., Carroll, R.J., Kenward, M.G. (2002). Analyzing incomplete longitudinal clinical trial data (with discussion). Biometrics, submitted.
19. Rubin, D., Shenker, N. (1991). Multiple imputations in health care databases: an overview and some applications. Stat. Med. 10:585-598.
20. Rubin, D. B., Stern, H. S., Vehovar, V. (1995). Handling "don't know" survey responses: the case of the Slovenian plebiscite. J. Am. Stat. Assoc. 90:822-828.
21. Siddiqui, O., Ali, M. W. (1998). A comparison of the random-effects pattern mixture model with last-observation-carried-forward (LOCF) analysis in longitudinal clinical trials with dropouts. J. Biopharm. Stat. 8:545-563.
22. Verbeke, G., Molenberghs, G. (2000). Linear Mixed Models for Longitudinal Data. New York: Springer.