Statistical analysis of biotech trials is very complex.
From the complaint:
17. Until January 15, 2022, Defendants represented Anavex would use particular primary and secondary research outcomes for its Avatar study about adult Rett syndrome. On February 1, 2022, the Company released its Avatar study results. The actual methods and outcomes used to analyze the Avatar study were different from those previously announced. Analysts critiqued these methods as being unusual and not clinically validated. Nonetheless, the Company persisted and claimed it would use these same tests for analysis of its Excellence trial about pediatric Rett syndrome.
This simply exposes the ignorance of the plaintiff and their council...
The post below is from a preview of a textbook titled "Statistical Design, Monitoring, and Analysis of Clinical Trials"
It clearly shows that analysis of trial data should be done more like a mining expedition than the book report that the plaintiff alleges.
Skip to main content Taylor & Francis Group Logo T&F eBooks Search for keywords, authors, titles, ISBN Advanced Search About Us Subjects Browse Products Request a trial Librarian Resources What's New!! HomeBiosciencePharmaceutical ScienceClinical Trials - Pharmaceutical ScienceStatistical Design, Monitoring, and Analysis of Clinical Trials Statistical Design, Monitoring, and Analysis of Clinical Trials Book
Statistical Design, Monitoring, and Analysis of Clinical Trials Principles and Methods ByWeichung Joe Shih, Joseph Aisner Edition2nd Edition First Published2021 eBook Published25 October 2021 Pub. LocationNew York ImprintChapman and Hall/CRC DOIhttps://doi.org/10.1201/9781003176527 Pages404 eBook ISBN9781003176527 SubjectsBioscience, Mathematics & Statistics, Medicine, Dentistry, Nursing & Allied Health Share Share
Citation ABSTRACT Statistical Design, Monitoring, and Analysis of Clinical Trials, Second Edition concentrates on the biostatistics component of clinical trials. This new edition is updated throughout and includes five new chapters.
Developed from the authors’ courses taught to public health and medical students, residents, and fellows during the past 20 years, the text shows how biostatistics in clinical trials is an integration of many fundamental scientific principles and statistical methods. The book begins with ethical and safety principles, core trial design concepts, the principles and methods of sample size and power calculation, and analysis of covariance and stratified analysis. It then focuses on sequential designs and methods for two-stage Phase II cancer trials to Phase III group sequential trials, covering monitoring safety, futility, and efficacy. The authors also discuss the development of sample size reestimation and adaptive group sequential procedures, phase 2/3 seamless design and trials with predictive biomarkers, exploit multiple testing procedures, and explain the concept of estimand, intercurrent events, and different missing data processes, and describe how to analyze incomplete data by proper multiple imputations.
This text reflects the academic research, commercial development, and public health aspects of clinical trials. It gives students and practitioners a multidisciplinary understanding of the concepts and techniques involved in designing, monitoring, and analyzing various types of trials. The book’s balanced set of homework assignments and in-class exercises are appropriate for students and researchers in (bio)statistics, epidemiology, medicine, pharmacy, and public health.
TABLE OF CONTENTS Chapter 1|28 pages Overview Abstract Chapter 2|23 pages Concepts and Methods of Statistical Designs Abstract Chapter 3|10 pages Efficiency with Trade-Offs and Crossover Designs Abstract Chapter 4|40 pages Sample Size and Power Calculations Abstract Chapter 5|34 pages Analysis of Covariance and Stratified Analysis Abstract Chapter 6|30 pages Regression Analysis of Survival Data Abstract Chapter 7|13 pages Sequential Designs and Methods—Part I: Expected Sample Size and Two-Stage Phase II Trials in Oncology Abstract Chapter 8|21 pages Sequential Designs and Methods—Part II: Monitoring Safety and Futility Abstract Chapter 9|28 pages Sequential Designs and Methods—Part III: Classical Group Sequential Trials Abstract Chapter 10|32 pages Monitoring the Maximum Information and Adaptive Sample Size Designs Abstract Chapter 11|19 pages Multiplicity Issues and Methods for Controlling the Type I Error Rate Abstract Chapter 12|18 pages Clinical Trials with Predictive Biomarkers Abstract Chapter 13|18 pages Seamless Phase II/III: Select-the-Winner Design Abstract Chapter 14|14 pages Statistical Significance and p-Values Abstract Chapter 15|34 pages Estimand, Intercurrent Events, and Missing Data Abstract You do not have access to this content currently. Please click 'Get Access' button to see if you or your institution have access to this content.
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