# Biopharmaceutical Sequential Statistical Applications

DOI link for Biopharmaceutical Sequential Statistical Applications

Biopharmaceutical Sequential Statistical Applications book

# Biopharmaceutical Sequential Statistical Applications

DOI link for Biopharmaceutical Sequential Statistical Applications

Biopharmaceutical Sequential Statistical Applications book

Edited ByKarl E. Peace

Edition 1st Edition

First Published 1992

eBook Published 25 March 1992

Pub. location Boca Raton

Imprint CRC Press

Pages 376 pages

eBook ISBN 9780429182761

SubjectsBioscience, Mathematics & Statistics

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#### Get Citation

Peace, K. (Ed.). (1992). Biopharmaceutical Sequential Statistical Applications. Boca Raton: CRC Press, https://doi.org/10.1201/9781482277128

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

ByPaul I. Feder, David W. Hobson, Carl T. Olson, R. L. Joiner, M. 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

ByZ±O.5uz,

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,

ByPaul I. Feder, Carl T. Olson, David W. Hobson, M. Claire Matthews, R. L. Joiner

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

positive control groups (e.g., standard therapy regimen) negative control groups (e.g., untreated animals). positive control groups response rate significantly greater according first-stage criterion, Schultz Elfring suggest entire repeated. Schultz Elfring recommend control charts check validity individual evaluate short-and long-term run-to-

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

ByofPublic

chapter 8|10 pages

#### Group Sequential Trial of Two Combination Chemotherapy Regimens in Good-Risk Patients with Advanced Germ Cell Tumors

Nancy L. Geller

ByofHealth,

chapter 9|6 pages

#### Early Termination of a Trial of Azidothymidine for the Treatment of Patients with AIDS and AIDS-Related Complex

Anthony

ByAnthony C. Segreti

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 10|18 pages

#### Interim Analysis of a Parallel Comparison Study of Dideoxycytidine Versus Azidothymidine in Patients with AIDS or Advanced AIDS-Related Complex

Samuel Givens

ByAmy H. Lin, Samuel V. Givens

chapter 12|7 pages

#### Bayesian Methods in the Monitoring of Survival in Congestive Heart Failure

ByNathan H. Enas, Federico Dies, Celedon R. Gonzales, Donald A. Berry

chapter 13|10 pages

#### Interim Analysis in the Norwegian Multicenter Study

ByIrving K. Hwang, Bruce E. Rodda

chapter 14|10 pages

#### Interim Analysis of the Helsinki Heart Study Primary Prevention Trial

ByHarry Haber

chapter 16|16 pages

#### Early Termination of Two Trials of Misoprostol in the Prevention of NSAID-Induced Gastric Ulceration

ByKarl E. Peace

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

ByRonald Pedersen, Robert R. Starbuck

chapter 20|6 pages

#### Use of Interim Analyses to Design Further Studies in Analgesic Drug Preference

ByAlbert J. Getson, Katherine H. Lipschutz, Robert L. Davis, Balasamy Thiyagarajan

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 22|6 pages

#### Randomized Play-the-Winner Designs and ECMO

Richard David D. Cuthbertson

ByofMichigan,

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