Longitudinal aggregate data model-based meta-analysis with NONMEM: Approaches to handling within treatment arm correlation

Journal of Pharmacokinetics and Pharmacodynamics

Volumn 37, Issue 2, 2010, Pages 179-201

  Ahn, Jae Eun ^a   French, Jonathan L ^a  

^a PFIZER INC   (United States)

Author keywords

Correlation; Longitudinal data; Model based meta analysis; Multi level random effects; NONMEM

Indexed keywords

PLACEBO;

ACCURACY; ARTICLE; ERROR; LONGITUDINAL STUDY; MEDICAL LITERATURE; META ANALYSIS; METHODOLOGY; MODEL; NONLINEAR MIXED EFFECT MODELING; PREDICTION; PRIORITY JOURNAL; PROBABILITY; RANDOMIZATION; SIMULATION; SYSTEMATIC ERROR; SYSTEMATIC REVIEW; UNCERTAINTY;

CLINICAL TRIALS AS TOPIC; COMPUTER SIMULATION; DATA INTERPRETATION, STATISTICAL; DOSE-RESPONSE RELATIONSHIP, DRUG; HUMANS; LONGITUDINAL STUDIES; META-ANALYSIS AS TOPIC; MODELS, STATISTICAL; OUTCOME ASSESSMENT (HEALTH CARE);

EID: 77953542886     PISSN: 1567567X     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10928-010-9152-6     Document Type: Article

References (30)

1. Glass GV (1976) Primary, secondary and meta-analysis of research. Educ Res 5:3-8
2. Piedbois P, Buyse M. (2004) Meta-analyses based on abstracted data: a step in the right direction, but only a first step. J Clin Oncol 22:3839-3841
3. Whitehead A (2002) Meta-analysis of controlled clinical trials. Wiley, New York
4. Hedges LV, Olkin I. (1985) Statistical methods for meta-analysis. Academic Press, New York
5. DerSimonian R, Laird N. (1986) Meta-analysis in clinical trials. Control Clin Trials 7:177-188
6. Houwelingen HCv, Arends LR, Stijnen T. (2002) Advanced methods in meta-analysis: multivariate approach and meta-regression. Stat Med 21:589-624
7. Nam I, Mengersen K., Garthwaite P. (2003) Multivariate meta-analysis. Stat Med 22:2309-2333
8. Ishak KJ, Platt RW, Joseph L., Hanley J.A., Caro J.J. (2007) Meta-analysis of longitudinal studies. Clin Trials 4:525-539
9. Peters JL, Mengersen K.L. (2008) Meta-analysis of repeated measures study designs. J Eval Clin Pract 14:941-950
10. Jones AP, Riley RD, Williamson P.R., Whitehead A. (2009) Meta-analysis of individual patient data versus aggregate data from longitudinal clinical trials. Clin Trials 6:16-27
11. Sutton AJ, Kendrick D., Coupland CAC (2008) Meta-analysis of individual and aggregate-level data. Stat Med 27:651-669
12. Suttonand AJ, Higgins JPT (2008) Recent developments in meta-analysis. Stat Med 27:625-650
13. Cook DJ, Sackett DL, Spitzer W.O. (1995) Methodologic guidelines for systematic reviews of randomized controlled trials in health care from the Potsdam consultation on meta-analysis. J Clin Epidemiol 48:167-171
14. Mandema JW, Cox E., Alderman J. (2005) Therapeutic benefit of eletriptan compared to sumatriptan for the acute relief of migraine pain-results of a model-based meta-analysis that accounts for encapsulation. Cephalalgia 25:715-725
15. Mandema JW, Hermann D., Wang W., Sheiner T, Milad M., Bakker-Arkema R, Hartman D. (2005) Model-based development of gemcabene a new lipid-altering agent. AAPS J 7:E513-E522
16. Lalonde RL, Kowalski KG, Hutmacher M.M., Ewy W., Nichols DJ, Milligan PA, Corrigan BW, Lockwood P.A., Marshall SA, Benincosa LJ, Tensfeldt TG, Parivar K., Amantea M., Glue P, Koide H, Miller R (2007) Model-based drug development. Clin Pharmacol Ther 82:21-32
17. Ito K, Ahadieh S., Corrigan B., French J, Fullerton T., Tensfeldt T., Alzheimer's Disease Working Group (2010) A disease progression meta-analysis model in Alzheimer's disease. Alzheimers Dement 6:39-53
18. Prins MGNH, Haughie S., Johnson P., Martin S.W. (2009) Use of model based meta-analysis combining patient-level with summary-level data using multilevel random effects to provide a quantitative assessment of the clinical efficacy (IPSS) profile and competitive positioning of a PDE5 inhibitor (UK369,003) for the treatment of benign prostatic hyperplasia (BPH). p 18, vol Abstr 1625, St. Petersburg, Russia
19. Venkatakrishnan K, Ezzet F., Ravva P., Tensfeldt TG, Chow V, Chew RD, Barbee T., Dvorak R.V., Taylor AE, Obourn JD, Benincosa L.J. (2008) Longitudinal dose-response analysis of the effects of sibutramine, orlistat and rimonabant on body weight progression in pooled obesity clinical trials: illustration of knowledge management in model-based drug development. Clin Pharmacol Ther 83(1):PII-45
20. Beal SL, Sheiner LB, Boeckmann AJ (eds) (1989-2006) NONMEM users guides, ICON Development Solutions, Ellicott City, MD
21. Laporte-Simitsidis S., Girard P., Mismetti P., Chabaud S, Decousus H., Boissel J.P. (2000) Inter-study variability in population pharmacokinetic meta-analysis: when and how to estimate it? J Pharm Sci 89:155-167
22. Karlsson MO, Sheiner L.B. (1993) The importance of modeling interoccasion variability in population pharmacokinetic analyses. J Pharmacokinet Biopharm 21:735-750
23. Karlsson MO, Beal SL, Sheiner L.B. (1995) Three new residual error models for population PK/PD analyses. J Pharmacokinet Biopharm 23:651-672
24. Silber HE, Kjellsson MC, Karlsson M.O. (2009) The impact of misspecification of residual error or correlation structure on the type I error rate for covariate inclusion. J Pharmacokinet Pharmacodyn 36:81-99
25. Agresti A (1990) Categorical data analysis. Wiley, New York
26. Karlsson MO, Holford N.H. (2008) A tutorial on visual predictive checks. p 17 Abstr 1434. www.page-meeting.org/?abstract=1434
27. Wakefield J (2008) Ecologic studies revisited. Annu Rev Public Health 29:75-90
28. Ishak KJ, Robert WP, Lawrence J., James A.H. (2008) Impact of approximating or ignoring within- study covariances in multivariate meta-analyses. Stat Med 27:670-686
29. Ian RW, Julian PTH, Angela M.W. (2008) Allowing for uncertainty due to missing data in metaanalysis-Part 1: two-stage methods. Stat Med 27:711-727
30. Ian RW, Nicky JW, Angela M.W., Ades AE, Julian PTH (2008) Allowing for uncertainty due to missing data in meta-analysis-Part 2: hierarchical models. Stat Med 27:728-745