On the use of historical control data in pre-clinical safety studies

Journal of Biopharmaceutical Statistics

Volumn 17, Issue 3, 2007, Pages 493-509

  Marringwa, J T ^a   Faes, C ^a   Aerts, M ^a   Geys, H ^a,b   Teuns, G ^b   Poel, B Van Den ^b   Bijnens, L ^b  

^a HASSELT UNIVERSITY   (Belgium)

^b JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

Author keywords

Bias; Dose trend; Empirical Bayes estimates; Examined study; Historical control studies; Logistic normal model; Power; Precision

Indexed keywords

ACCURACY; ANAMNESIS; ARTICLE; CLINICAL RESEARCH; DATA ANALYSIS; DRUG SCREENING; NONRESPONSE BIAS; POWER OF A TEST; PRIORITY JOURNAL; RISK ASSESSMENT; SAFETY; SIMULATION; STATISTICAL MODEL; TREATMENT OUTCOME;

ANIMALS; COMPUTER SIMULATION; DATA INTERPRETATION, STATISTICAL; DRUG EVALUATION, PRECLINICAL; EMPIRICAL RESEARCH; LOGISTIC MODELS; MODELS, BIOLOGICAL; MODELS, STATISTICAL; NORMAL DISTRIBUTION; RESEARCH DESIGN; SPECIES SPECIFICITY;

EID: 34247844353     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543400701216355     Document Type: Article

References (14)

1. Breslow, N. E., Lin, X. (1995). Bias correction in generalised linear mixed models with a single component of dispersion. Biometrika 82:81-91.
2. Cordeiro, G. M., McCullagh, P. (1991). Bias correction in generalized linear models. Journal of the Royal Statistical Society B 53:629-643.
3. DeGruttola, V., Lange, N., Dafni, U. (1991). Modeling the progression of HIV infection. Journal of the American Statistical Association 86:569-577.
4. Dempster, A. P., Selwyn, M. R., Weeks, B. J. (1983). Combining historical and randomized controls for assessing trends in proportions. Journal of the American Statistical Association 78:221-227.
5. Dom, P., Janssen, T., Coussement, W. (2000). Oral developmental toxicity study in the Rabbit GLP-study. Janssen Pharmaceutica N. V Non-Clinical Laboratory Study Protocol number 5260: Technical report. Johnson and Johnson Pharmaceutical Research and Development, Beerse, Belgium.
6. Hoel, D. G. (1983). Conditional two sample tests with historical controls. In: Sen, P. K., ed. Contributions to Statistics: Essays in Honour of Normal L. Johnson. Amsterdam: North Holland Publishing Company, pp. 229-236.
7. Ibrahim, J. G., Ryan, L. M. (1996). Use of historical controls in time-adjusted trend tests for carcinogenicity. Biometrics 52:1478-1485.
8. Ibrahim, J. G., Ryan, L. M., Chen, M. H. (1998). Use of historical controls to adjust for covariates in trend tests for binary data. Journal of the American Statistical Association 93:1282-1293.
9. Kikuchi, Y., Yanagawa, T. (1991). Incorporating historical controls using a random effects models with a normal prior. Commun. Statisti.-Theory Meth. 20(4):1273-1291.
10. Ryan, L. (1993). Using historical controls in the analysis of developmental toxocity data. Biometrics 49:1126-1135.
11. Parise, H., Wand, M. P., Ruppert, D., Ryan, L. (2001). Incorporation of historical controls using semi-parametric mixed models. Applied Statistics 50(1):31-42.
12. Shapiro, S. S., Wilk, M. B. (1965). An analysis of variance test for normality (complete samples). Biometrika 52:591-611.
13. Tarone, R. E. (1982). The use of historical control information in testing for trend in proportions. Biometrics 38:215-220.
14. Verbeke, G., Molenberghs, G. (2000). Linear Mixed Models for Longitudinal Data. New York: Springer.