Laboratory data in clinical trials: A statistician's perspective

Controlled Clinical Trials

Volumn 19, Issue 2, 1998, Pages 167-177

  Chuang Stein, Christy ^a  

^a PFIZER INC   (United States)

Author keywords

Laboratory toxicity; Multicenter clinical trial; Reference range; Safety profile

Indexed keywords

ARTICLE; CLINICAL RESEARCH; DATA ANALYSIS; HUMAN; INFORMATION PROCESSING; LABORATORY; STATISTICAL ANALYSIS;

EID: 0032053723     PISSN: 01972456     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0197-2456(97)00123-2     Document Type: Article

References (24)

1. Smith A. Report of the PSI (Statisticians in the Pharmaceutical Industry) Laboratory Data Working Party. 1980.
2. Royston P, Matthews JNS Estimation of reference ranges from normal samples. Stat Med. 10:1991;691-695.
3. DiCiccio TJ, Efron B Bootstrap confidence intervals. Stat Sci. 11:1996;189-228.
4. Oliver LK, Chuang-Stein C Laboratory data in multi-center trials. Monitoring, adjustment and summarization Gilbert G Drug Safety Assessment in Clinical Trials. 1993;111-123 Marcel Dekker, New York.
5. Thompson WL, Brunelle RL, Enas GGet al. Routine laboratory tests in clinical trials. Cato AE Clinical Trials and Tribulations. 1988;1-54 Marcel Dekker, New York.
6. Silliman NP. Hidden issues concerning laboratory data analysis [discussion]. Joint Statistical Meetings, Chicago, 1996.
7. Tufte ER The Visual Display of Quantitative Information. 1983;Graphics Press, Cheshire. pp. 170-175.
8. Brown KR, Getson AJ, Gould ALet al. Safety of cefoxitin. an approach to the analysis of laboratory data Rev Infectious Dis. 1:1979;228-231.
9. Sogliero-Gilbert G, Mosher K, Zubkoff L A procedure for the simplification and assessment of lab parameters in clinical trials. Drug Info J. 20:1986;279-296.
10. Gilbert GS, Ting N, Zubkoff L A statistical comparison of drug safety in controlled clinical trials. the Genie score as an objective measure of lab abnormalities Drug Info J. 25:1991;81-96.
11. Chuang-Stein C, Mohberg NR, Musselman DM The organization and analysis of safety data using a multivariate approach. Stat Med. 11:1992;1075-1089.
12. Chuang-Stein C The regression fallacy. Drug Info J. 27:1993;1213-1220.
13. Davis CE The effect of regression to the mean in epidemiologic and clinical studies. Am J Epidemiol. 104:1976;493-498.
14. Ederer F Serum cholesterol changes. effects of diet and regression toward the mean J Chron Dis. 25:1972;277-289.
15. Gardner MJ, Heady JA Some effects of within-person variability in epidemiological studies. J Chron Dis. 26:1973;781-795.
16. Cherng NC, et al. Some approaches to the evaluation and display of laboratory safety data. Joint Statistical Meetings, Chicago, 1996.
17. Conover WJ, Salsburg DS Locally most powerful tests for detecting treatment effects when only a subset of patients can be expected to "respond" to treatment. Biometrics. 44:1988;189-196.
18. O'Brien PC Comparing two samples. Extensions of the t, rank-sum, and log-rank tests JASA. 83:1988;52-61.
19. Ostle B, Malone LC Statistics in Research, Basic Concepts and Techniques for Research Workers. 4:1988;Iowa State University Press, Ames. pp. 132-144.
20. Wilks SS Mathematical Statistics. 1962;Wiley & Sons, New York. pp. 329-341.
21. Sachs L Applied Statistics, A Handbook of Techniques. 2:1984;Springer-Verlag, New York. translated by Reynarowych Z) , pp. 281-284.
22. Nickens DJ. Using tolerance limits to evaluate laboratory data. Joint Statistical Meetings, Chicago, 1996.
23. Lechner JA, Simiu E, Heckert NA Assessment of peaks over threshold methods for estimating extreme-value distribution tails. Structural Safety. 12:1993;305-314.
24. Smith RL Extreme value analysis of environmental time series. an application to trend detection in ground-level ozone Stat Sci. 4:1989;367-393.