Advances in Clinical Trial Biostatistics by Nancy L. Geller

By Nancy L. Geller

From elements of early trials to advanced modeling difficulties, Advances in scientific Trial Biostatistics summarizes present methodologies utilized in the layout and research of medical trials. Its chapters, contributed by way of the world over well known methodologists skilled in scientific trials, tackle subject matters that come with Bayesian equipment for part I scientific trials, adaptive two-stage scientific trials, and the layout and research of cluster randomization trials, trials with a number of endpoints, and healing equivalence trials. different discussions discover Bayesian reporting, tools incorporating compliance in remedy assessment, and statistical concerns rising from medical trials in HIV infection.

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Dillman, R. , Koziol, J. A. (1992). Phase I cancer trials: Limitations and implications. Molecular Biotherapy 4:117–121. Eichhorn, B. , Zacks, S. (1973). Sequential search of an optimal dosage I. Journal of American Statistical Association 68:594–598. Copyright n 2004 by Marcel Dekker, Inc. All Rights Reserved. Bayesian Methods for Cancer Phase I Clinical Trials 37 Eichhorn, B. , Zacks, S. (1981). Bayes sequential search of an optimal dosage: Linear regression with both parameters unknown. Communications in Statistics-Theory and Methods 10:931–953.

2. Delayed Response Since cancer patients often exhibit delayed response to treatment, the time required to definitively evaluate treatment response can be longer than the average time between successive patient accruals. , 1990). It is therefore important to note that Bayesian procedures do not require knowledge of the responses of all patients currently on study before a newly accrued patient can begin treatment. , 1990; Babb et al, 1998). Thus, it can be left to the discretion of the clinician to determine whether to treat a newly accrued patient at the dose recommended on the basis of all currently known responses, or to wait until the resolution of one or more unknown responses and then treat the new patient at an updated determination of dose.

Lecture Notes in Statistics. New York: Springer-Verlag, pp. 324–336. , Eisele, J. (2000). A curve-free method for phase I clinical trials. Biometrics 56:609–615. , Greenhouse, J. B. (1992). Bayesian methods for phase I clinical trials. Statistics in Medicine 11:1377–1389. Geller, N. L. (1984). Design of phase I and II clinical trials in cancer: a statistician’s view. Cancer Investigation 2:483–491. Goodman, S. , Zahurak, M. , Piantadosi, S. (1995). Some practical improvements in the continual reassessment method for phase I studies.

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