Abstract
Statistics in medical research is no longer what it was some 15 years ago: some descriptive measures for a collection of numbers and P-values based on tests appropriately chosen according to the type of data used
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
Altman, D. G., 1996, Better reporting of randomised controlled trials: the CONSORT statement, Brit. Med. J 313:570-571
Bauer, P., 1989, Multistage testing with adaptive designs, Biom. Inf. Med. Biol 20:130-148
Bauer, P., and Köhne, K., 1994, Evaluation of experiments with adaptive interim analyses, Biometrics 50:1929-1041
Browner, W. S., and Newman, T. B., 1987, Are all significant P values created equal? The analogy between diagnostic tests and clinical research. JAMA 257:2459-2463
Cohen, J., 1969, Statistical Power Analysis for the Behavioral Sciences, Academic Press, New York (Rev. Ed. 1977)
Colditz G. A., Miller, J. N., and Mosteller, F., 1988, Measuring gain in the evaluation of medical technology. Intern. J. Technol. Assess. Health Care 4:637-642
Cook, R. J., and Sackett, D. L., 1995, The number needed to treat: A clinical useful measure of treatment effect, Brit. J. Med 310:452-454
Diamond, G. A., and Forrester, J. S., 1983, Clinical trials and statistical verdicts: Probable grounds for appeal. Ann. Int. Med 98:385-394
EU Bioequivalence Guideline, 1991, CPMP Working Party on Efficacy of Medicinal Products, Note for Guidance, Investigation of Bioavailability and Bioequivalence, Brussels, Belgium: CPMP (December 1991)
EU-Biostatistics Guideline, 1994, Commitee for the Proprietary Medicinal Products. A Note for Guidance on Biostatistical Methodology in Clinical Trials in Applications for Marketing Authorizations for Medicinal Products, Brussels, Belgium: CPMP (December 1994)
FDA Guideline 1988, Guideline for the Format and Content of Clinical and Statistical Sections of New Drug Applications. Rockville, MD, US Food and Drug Administration
FDA, 1992, Points to consider, Division of Anti-Infective Drug Products
Gardner, M. J., and Altman, D. G., 1986, Confidence intervals rather than P values: Estimation ratherthan hypothesis testing, Brit. Med. J 292:746-750
Gardner, M. J., Machin, D., and Campbell, M. J., 1986, Use of check lists in assessing the statistical content of medical studies, Brit. Med. J 292:810-812
German Guideline, 1987, Principles for the Proper Performance of a Clinical Study: Bekanntmachung von Grundsätzen für die ordnungsgemäße Durchführung der klinischen Prüfung, Bundesminister fur Jugend, Familie, Frauen, Gesundheit (BMJFFG) (9.12.1987)
Graubard, B. I., and Korn, E. L., 1987, Choice of column scores for testing independence in ordered 2 × k contingency tables, Biometrics 43:471-476
Hasselblad, V., and Hedges, L. V., 1995, Meta-analysis of screening and diagnostic tests, Psychol. Bull 117:167-178
Holm, S., 1979, A simple sequentially rejective multiple test procedure, Scand. J. Stat 6:65-70
ICH-Biostatistics Guideline, 1998, ICH Harmonized Tripartite Guideline, Note for Guidance on Statistical Principles for Clinical Trials, ICH Topic E9, Step 4, Consensus Guideline (February 5, 1998)
Johnson, A., 1985, Sample size: clues, hints or suggestions, J. Chron. Dis 38:721-725
Lachin J. M., 1992, Some large-sample distribution-free estimators and tests for multivariate partially incomplete data from two populations. Stat. Med 11:1151-1170
Laupacis, A., Sackett, D. L., and Roberts, R. S., 1988, An assessment of clinically useful measures of the consequences of treatment, New Engl. J. Med 318:1728-1733
Lehmacher W., 1989, Schrittweises multiples Testen bei a-priori-geordneten Hypothesen, Int. Report, Gesellschaft für Strahlen- und Umweltforschung (GSF), MEDIS, Neuherberg/Munich, Germany
Mantel, N., 1963, Chi-square tests with one degree of freedom: Extensions of the Mantel-Haenszel procedure, J. Am. Stat. Assoc 58:690-700
Maurer, W., 1987, Statistische Besonderheiten bei klinischen Studien, Biometrisches Seminare, Locarno (September 21-25, 1987)
Maurer, W. Hothorn, L. A., and Lehmacher, W., 1995, Multiple comparisons in drug clinical trials and preclinical assays: A priori ordered hypotheses, in: Testing Principles in Clinical and Preclinical Trials, Biometrie in der chemisch-pharmazeutischen Industrie (J. Vollmar ed.) Gustav Fischer, Stuttgart, pp. 3-18
Noether, G. E., 1987, Sample size determination for some common nonparametric tests, J. Am. Stat. Assoc 82:645-647
O’Brien, P. C, 1984, Procedures for comparing samples with multiple endpoints, Biometrics 40:1079-1087
Phillips. A., 1998, Sample size estimation when comparing more than two treatment groups, Drug Inf. J 32:193-199
Rahlfs, V. W., and Zimmermann, H., 1993, Scores: Ordinal data with few categories-how should they be analyzed? Drug Inf. J 27:1227-1240
Röhmel, J., 1998, Therapeutic equivalence investigations: statistical considerations, Statist. Med 17: 1703-1714
Rosenthal, R., 1991, Meta-Analytic Procedures for Social Research, Sage Publications, Newbury Park
Streitberg, B., 1991, Review of: Daniel, W. W., Applied Nonparametric Statistics, 2nd Ed, PWS-Kent, Boston
Streitberg, B.1990, Biometrics 47:1634-1635
Tritchler, D., 1995, Interpreting the standardized difference, Biometrics 51:351-353
US Bioequivalence Guideline, 1992, Statistical Procedures for Bioequivalence Studies Using a Standard Two-Treatment Crossover Design, Division of Bioequivalence (HFD-650), Food and Drug Administration, Rockville, MD 20855
Wei L. J., and Lachin J. M., 1984, Two-sample asymptotically distribution-free tests for incomplete multivariate observations. J. Am. Stat. Assoc 79:653-661
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2000 Springer Science+Business Media New York
About this chapter
Cite this chapter
Rahlfs, V.W. (2000). Statistics in Clinical Research. In: Schwindt, D.A., Maibach, H.I. (eds) Cutaneous Biometrics. Springer, Boston, MA. https://doi.org/10.1007/978-1-4615-1199-1_1
Download citation
DOI: https://doi.org/10.1007/978-1-4615-1199-1_1
Publisher Name: Springer, Boston, MA
Print ISBN: 978-1-4613-5437-6
Online ISBN: 978-1-4615-1199-1
eBook Packages: Springer Book Archive