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Electronic delivery tracking will be issued free of charge. Not a MyNAP member yet? Register for a free account to start saving and receiving special member only perks. This bibliography is a selection of published references dealing with analytical approaches and statistical methods applicable to clinical trials, particularly small clinical trials.


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The citations span the field broadly and are the result of searches of the Medline database and suggestions from the committee and from the experts in the field who made presentations at the committee's invitational workshop. The references are organized into specific categories to aid the reader. Although comprehensive, the list is selective, and the committee believes that it is an up-to-date bibliography that will assist researchers in learning more about design and analytical methods applicable to small clinical trials.

Bohning, D. Cai, J. Zhou, and C.

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Estimating the mean hazard ratio parameters for clustered survival data with random clusters. Statistics in Medicine — D'Agostino, R. Measuring effectiveness. What to expect without a randomized control group.

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Medical Care 33 Suppl. Davis, C. Secondary endpoints can be validly analyzed, even if the primary endpoint does not provide clear statistical significance. Controlled Clinical Trials — Hunsberger, D. Murray, R. Fabsitz, J. Himes, L. Stephenson, B. Caballero, and B. Design and statistical analysis for the Pathways study. American Journal of Clinical Nutrition 69 Suppl.

Dieterich, M. Goodman, R. Rojas-Corona, A. Emralino, J, D, Jimenez, and M. Multivariate analysis of prognostic features in malignant pleural effusions from breast cancer patients. Acta Cytologica — Everitt, B.

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Statistical Methods in Medical Investigations. New York: Halsted Press. New York: Cambridge University Press. Gehan, E. A generalized two-sample Wilcoxon test for doubly censored data.

Biometrika — Gibbons, J. Olkin, and M. Philadelphia: SIAM. Gilbert, P. Self, and M. Statistical methods for assessing differential vaccine protection against human immunodeficiency virus types. Biometrics — Goodman, S. A comment on replication, p-values and evidence. P values, hypothesis tests, and likelihood: implications for epidemiology of a neglected historical debate. American Journal of Epidemiology —; Discussion, — Confidence limits vs power, calculations. Epidemiology — Discussion, — Toward evidence-based medical statistics. The P value fallacy.

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Annals of Internal Medicine — The Bayes factor. The use of predicted confidence intervals when planning experiments and the misuse of power when interpreting results. Altman, and S.