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By Nancy L. Geller

From facets of early trials to advanced modeling difficulties, this beneficial reference summarizes present method utilized in the layout and research of scientific trials. Chapters are contributed by means of across the world respected methodologists skilled in scientific trials perform.

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30 Babb and Rogatko made for individual differences in susceptibility to the treatment (Dillman and Koziol, 1992). Recent developments in our understanding of the genetics of drug-metabolizing enzymes and the importance of individual patient differences in pharmacokinetic and relevant clinical parameters is leading to the development of new treatment paradigms (ASCO, 1997). For example, the observation that impaired renal function can result in reduced clearance of carboplatin, led to the development of dosing formulas based on renal function that permit careful control over individual patient exposure (Newell, 1994).

Once these estimates have been obtained, the multiple agent trial can proceed according to CRML exactly as it applies to a single agent trial. 7. Incorporation of Covariate Information As defined above, the MTD may well quantify the average response of a specific patient population to a particular treatment, but no allowance is Copyright n 2004 by Marcel Dekker, Inc. All Rights Reserved. 30 Babb and Rogatko made for individual differences in susceptibility to the treatment (Dillman and Koziol, 1992).

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. 3. Rapid Initial Escalation Recently, ethical concerns have been raised regarding the large number of patients treated in cancer phase I trials at potentially biologically inactive dose levels (Hawkins, 1993; Dent and Eisenhauer, 1996).

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