ABSTRACT
Focusing on group sequential procedures, summarizes the sequential statistical methods used in anticancer, antiviral, cardiovascular, and gastrointestinal drug research and screening. The clinical and preclinical applications are mainly presented as case studies, many of which form part of New Drug
TABLE OF CONTENTS
chapter 3|8 pages
Group Sequential Designs for Trials with Multiple Endpoints
Nancy L. Geller Clare Gnecco*
chapter 4|20 pages
Statistical Design Considerations for Stagewise, Adaptive Dose Allocation in Dose-Response Studies
Paull. Feder, David W. Hobson, Olson, Joiner,* Claire Matthews
chapter V|26 pages
=(T)-l
Expected variance-covariance matrix parameters following stage, analysis compare candidate designs Sensitivity analysis results terms precision estimation of percentiles interest (e.g., In(SI) where selected (asymptotically) uncorrelated. denote standard errors these quantities. Perturb pairs perturbed values with sever perturbed
chapter 5|6 pages
Stagewise, Group Sequential Experimental Designs for Comparisons of Quantal Response Levels Obtained with Candidate Treatment Regimens Versus Those with a Con- current Control or a Specified Standard
Paull. Feder, Olson, David W. Hobson,
chapter |10 pages
= 0.15 and =
0.30. fully sequential plan, based sequen- probability ratio (SPRT) (Wetherill, 1966, Chaps. 2-4), requires analysis after each decide whether continue. addition, boun- "open," which means realizations procedure might require extremely large sample sizes, perhaps somewhat larger fixed-sample-size procedure. these reasons, testing Stagewise Plans Stagewise plans compromises between efficiency fully sequential plans logistical practicality fixed-sample-size
part |1 pages
Ji -Ji
chapter |15 pages
P(X= + )(
scores within decision whether particular stage or continue stage based cumulative sum Because scores within merely difference between number responses
chapter 6|14 pages
Application of a Sequential Screeningl Efficacy Design in an Advanced Colorectal Cancer Study
Samuel Wieand Daniel Schaid
chapter 7|22 pages
Group Sequential Methods in Multi-institutional Cancer CI1nical Trials: A Case Study
Study Kathleen Propert Kyungmann Kim
chapter 8|10 pages
Group Sequential Trial of Two Combination Chemotherapy Regimens in Good-Risk Patients with Advanced Germ Cell Tumors
Nancy L. Geller
part |1 pages
+ of
chapter |3 pages
mv-infected
patients, within benefit earlier otherwise would have, while still providing substantial evidence safety and efficacy required regulatory approval. large number trials confirmed these results other HIV-infected populations. Although recommended dosing modified since early trial, the
chapter 19|12 pages
Interim Analysis in the Development of an Anti-Inflammatory Agent: Sample Size Reestimation and Conditional Power Analysis
Sample Reestimation Conditional Power Analysis Ronald Pedersen Robert R. Starbuck
chapter |5 pages
= 0.025
survivors out of confirmed cases deaths) survivor out of confirmed cases deaths) deaths occurred confirmed cases are completed significant difference between survival trolene sodium
chapter |3 pages
< when
reaches order rejection hypothesis better control therapy. method different gested Cornell (1986), formula for posterior probability. probability treatment therapy. corresponding probability ECMO. Under hypothesis, Under alternative hypothesis, definitions consistent those given earlier terms probability under inferior treatments. Similarly, refer numbers balls added tively. design considered provides modification decision
chapter |3 pages
= 0.2, = = 0 or = 1 (no acceleration), tables in Cornell et al. (1986) display a minimum
acceleration), Cornell (1986) display minimum value 0.95. corresponding values respectively. Suppose require hypothesis. procedure described here, leads minimum value paired
