Biostatistics in Biopharmaceutical Research and Development : Clinical Trial Design, Volume 1 / edited by Ding-Geng Chen.

Format:

Book

Author/Creator:

Chen, Ding-Geng.

Series:

Medicine Series

Language:

English

Subjects (All):

Biometry.

Clinical medicine--Research.

Clinical medicine.

Public health.

Sampling (Statistics).

Data mining.

Biostatistics.

Clinical Research.

Public Health.

Survey Methodology.

Data Mining and Knowledge Discovery.

Local Subjects:

Biostatistics.

Clinical Research.

Public Health.

Survey Methodology.

Data Mining and Knowledge Discovery.

Physical Description:

1 online resource (355 pages)

Edition:

1st ed. 2024.

Place of Publication:

Cham : Springer Nature Switzerland : Imprint: Springer, 2024.

Summary:

The Deming Conference on Applied Statistics has long been deemed an influential event in the biostatistics and biopharmaceutical profession. It provides learning experience on recent developments in statistical methodologies in biopharmaceutical applications and FDA regulations. This book honors 80 years of contributions and dedication of the Deming Conference in biostatistics, and biopharmaceutical clinical trial methodology and applications. All chapters are contributed by world-class and prominent Deming speakers, who've contributed their cutting-edge research and developments to the community. Volume 1 covers Historical Milestones in Clinical Trial Design, FDA biopharmaceutical design guidance, and emerging development in Clinical Trial Design Methodology. This book aims to booster research, education, and training in biostatistics and in biopharmaceutical research and development.

Contents:

Bias and Randomization in Clinical Trials: 1980s – 2020s – 2060s

The Markov Model for Survival Trials at 35 Years-Old

Absolute Power Corrupts Absolutely: A Review of the Use of Unconditional Probabilities in the Planning of Clinical Trials

Design of Clinical Trials with the Desirability of Outcome Ranking Methodology

Benefit:Risk Assessments during Clinical Trials: A Prediction Approach Using the Desirability of Outcome Ranking (DOOR)

The Power of Integration: How the 2-in-1 Clinical Trial Design is Changing the Future of Drug Development

A Unified Bayesian Decision Rule-Based Approach for Bayesian Design of Clinical Trials Using Historical Data

Group Sequential Design Under Non-proportional Hazards: Methodologies and Examples

Multiple Testing in Group Sequential Design

Plan per-protocol (PP) causal inference analysis addressing intercurrent events following the targeted learning roadmap

Maximum Tolerated Imbalance Randomization: Theory and Practice

Response-adaptive randomization designs based on optimal allocation proportion.

Notes:

Description based on publisher supplied metadata and other sources.

Other Format:

Print version: Chen, Ding-Geng Biostatistics in Biopharmaceutical Research and Development

ISBN:

9783031659485

OCLC:

1490381798