Estimands, Estimators and Sensitivity Analysis in Clinical Trials

ISBN-10: 0429950063
ISBN-13: 9780429950063
Category: Medical
Pages: 318
Language: English
Published: 2019-12-23
Publisher: CRC Press
Authors: Geert Molenberghs, Bohdana Ratitch, Craig Mallinckrodt

Description

The concepts of estimands, analyses (estimators), and sensitivity are interrelated. Therefore, great need exists for an integrated approach to these topics. This book acts as a practical guide to developing and implementing statistical analysis plans by explaining fundamental concepts using accessible language, providing technical details, real-world examples, and SAS and R code to implement analyses. The updated ICH guideline raises new analytic and cross-functional challenges for statisticians. Gaps between different communities have come to surface, such as between causal inference and clinical trialists, as well as among clinicians, statisticians, and regulators when it comes to communicating decision-making objectives, assumptions, and interpretations of evidence. This book lays out a path toward bridging some of these gaps. It offers  A common language and unifying framework along with the technical details and practical guidance to help statisticians meet the challenges  A thorough treatment of intercurrent events (ICEs), i.e., postrandomization events that confound interpretation of outcomes and five strategies for ICEs in ICH E9 (R1)  Details on how estimands, integrated into a principled study development process, lay a foundation for coherent specification of trial design, conduct, and analysis needed to overcome the issues caused by ICEs:  A perspective on the role of the intention-to-treat principle  Examples and case studies from various areas  Example code in SAS and R  A connection with causal inference  Implications and methods for analysis of longitudinal trials with missing data Together, the authors have offered the readers their ample expertise in clinical trial design and analysis, from an industrial and academic perspective.

Get the book

Similar books

How Institutions are Shaping the Future of Our Children: For Better or for Worse?
By Catherine Dulmus, Karen Sowers
Lammert, M., & Timberlake, E. M. (1986). Termination of foster care for the older adolescent: Issues of emancipation and individuation.
Reversibility of Chronic Disease and Hypersensitivity, Volume 5: Treatment Options of Chemical Sensitivity
By William J. Rea, Kalpana D. Patel
Dou, L., E. Bertrand, C. Cerini, V. Faure, J. Sampol, R. Vanholder, Y. Berland, P. Brunet. ... A. Timberlake, B. Sumpio, R. Pfragner, I. M. Modlin, M. Kidd.
Rockwood and Green's Fractures in Adults
By William Ricci, Charles M. Court-Brown, Margaret M. McQueen
Chendrasekhar A, Moorman DW, Timberlake GA. An evaluation of the effects of ... Chittiboina P, Wylen E, Ogden A, et al. Traumatic spondylolisthesis of the ...
Breast Pathology, An Issue of Surgical Pathology Clinics
By Laura C. Collins
Hartmann LC, Radisky DC, Frost MH, et al. Understanding the premalignant potential of ... D'Alfonso TM, Wang K, Chiu YL, et al. Pathologic upgrade rates on ...
Telepractice in Speech-Language Pathology
By K. Todd Houston
Stensland, J., Speedie, S., Ideker, M., House, J., & Thompson, T. (1999). The relative cost of outpatient ... Deal, J. L. (1987). Appraisal and diagnosis of ...
Addressing Adversity: Prioritising adversity and trauma-informed care for children and young people in England.
By Marc Bush, Lord Victor Adebowale, Rebecca Adlington
1 2 Howard, S. and Johnson, B. (2000) Resilient and Non-resilient Behaviour in ... 4 De Haan, L., Hawley, D. and Deal, J. (2002) 'Operationalizing family ...
Culture, Brain, and Analgesia: Understanding and Managing Pain in Diverse Populations
By Mario Incayawar, Knox H. Todd
... are not fluent in the language/s of the medical care provider.72 Research ... Anglo-Americans have traditionally placed a great deal of emphasis on the ...
Image-Guided Spine Interventions
By John M. Mathis
This practical guide thoroughly discusses both well-established and new interventions that are applied to the spine for the purpose of pain relief.
New Mynursinglab -- Access Card -- For Maternal-Child Nursing (24-Month Access)
By Pearson Education, Pearson Education, Inc., David P Pearson Education
Several versions of Pearson's MyLab & Mastering products exist for each title, including customized versions for individual schools, and registrations are not transferable.
Pearson's Medical Assisting (General)
By Pearson Education Staff, Madan Dr Pearson Education
If a picture paints a thousand words, imagine what video can do? Pearson Medical Assisting Videos help users learn the nuances and the details of many medical assisting procedures.