Strategy and Statistics in Clinical Trials

• Author : Joseph Tal
• Publisher : Academic Press
• Release : 18 May 2021

Strategy and Statistics in Clinical Trials is for all individuals engaged in clinical research, including professors, physicians, researchers in corporate and government laboratories, nurses, members of the allied health professions, and post-doctoral and graduate students who are potentially less exposed to understanding the pivotal role of statistics. . Enables nonstatisticians to better understand research processes and statistics' role in these processes . Offers real-life case studies and provides a practical, "how to" guide to biomedical R&D . Delineates the statistical building blocks

• Author : Anonim
• Publisher : Unknown
• Release : 18 May 2021

• Author : Mark Chang,John Balser,Jim Roach,Robin Bliss
• Publisher : CRC Press
• Release : 20 March 2019

"This is truly an outstanding book. [It] brings together all of the latest research in clinical trials methodology and how it can be applied to drug development.... Chang et al provide applications to industry-supported trials. This will allow statisticians in the industry community to take these methods seriously." Jay Herson, Johns Hopkins University The pharmaceutical industry's approach to drug discovery and development has rapidly transformed in the last decade from the more traditional Research and Development (R & D) approach to

• Author : Walter R. Young,Ding-Geng (Din) Chen
• Publisher : CRC Press
• Release : 20 November 2014

Since 1945, "The Annual Deming Conference on Applied Statistics" has been an important event in the statistics profession. In Clinical Trial Biostatistics and Biopharmaceutical Applications, prominent speakers from past Deming conferences present novel biostatistical methodologies in clinical trials as well as up-to-date biostatistical applications from the pharmaceutical industry. Divided into five sections, the book begins with emerging issues in clinical trial design and analysis, including the roles of modeling and simulation, the pros and cons of randomization procedures, the design of

• Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials
• Publisher : National Academies Press
• Release : 01 February 2001

Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of

• Author : Flora Hammond, MD,James Malec, PhD,Todd Nick,Ralph Buschbacher, MD
• Publisher : Demos Medical Publishing
• Release : 26 August 2014

The majority of physicians are poorly knowledgeable about statistics and research design, yet are expected to do clinical research and write articles (if in academia) or, at the very least, to read the literature critically and provide evidence-based care to patients. The basic skills involved are touched on very minimally in residency, but not in enough depth for an untrained investigator to successfully design or conduct a study, or analyze research findings in any meaningful way. This volume is intended

• Author : Shein-Chung Chow
• Publisher : CRC Press
• Release : 19 April 2016

In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good clinical practice. But by identifying the causes of the issues and correcting them, the study objectives of clinical trials can be better achieved. Controversial Statistical Issues in Clinical Trials covers commonly encountered controversial statistical issues in clinical trials and, whenever possible, makes recommendations to resolve these problems. The book focuses on issues occurring at various stages of clinical research and development,

• Author : Ying-Kuen K. Cheung
• Publisher : Unknown
• Release : 18 May 2021

• Author : Albert Vexler,Alan D. Hutson,Xiwei Chen
• Publisher : CRC Press
• Release : 19 December 2017

Statistical Testing Strategies in the Health Sciences provides a compendium of statistical approaches for decision making, ranging from graphical methods and classical procedures through computationally intensive bootstrap strategies to advanced empirical likelihood techniques. It bridges the gap between theoretical statistical methods and practical procedures applied to the planning and analysis of health-related experiments. The book is organized primarily based on the type of questions to be answered by inference procedures or according to the general type of mathematical derivation. It

• Author : Michael A. Proschan,K. K. Gordon Lan,Janet Turk Wittes
• Publisher : Springer Science & Business Media
• Release : 31 December 2006

The approach taken in this book is, to studies monitored over time, what the Central Limit Theorem is to studies with only one analysis. Just as the Central Limit Theorem shows that test statistics involving very different types of clinical trial outcomes are asymptotically normal, this book shows that the joint distribution of the test statistics at different analysis times is asymptotically multivariate normal with the correlation structure of Brownian motion ("the B-value") – irrespective of the test statistic. Thus, this

• Author : Yanning Liu
• Publisher : Unknown
• Release : 11 January 2017

• Author : Salah M. Abdel-aleem
• Publisher : John Wiley & Sons
• Release : 09 September 2011

Clinical trials tasks and activities are widely diverse and require certain skill sets to both plan and execute. This book provides professionals in the field of clinical research with valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It discusses key obstacles such as challenges to patient recruitment, investigator and study site selection, and dealing with compliance issues. Through practical examples, professionals working with medical device clinical

• Author : Alex Dmitrienko,Gary G. Koch
• Publisher : SAS Institute
• Release : 17 July 2017

Analysis of Clinical Trials Using SAS®: A Practical Guide, Second Edition bridges the gap between modern statistical methodology and real-world clinical trial applications. Tutorial material and step-by-step instructions illustrated with examples from actual trials serve to define relevant statistical approaches, describe their clinical trial applications, and implement the approaches rapidly and efficiently using the power of SAS. Topics reflect the International Conference on Harmonization (ICH) guidelines for the pharmaceutical industry and address important statistical problems encountered in clinical trials. Commonly

• Author : C. Ralph Buncher,Jia-Yeong Tsay
• Publisher : CRC Press
• Release : 07 March 2019

The growth of the pharmaceutical industry over the past decade is astounding, but the impact of this growth on statistics is somewhat confusing. While software has made analysis easier and more efficient, regulatory bodies now demand deeper and more complex analyses, and pharmacogenetic/genomic studies serve up an entirely new set of challenges. For more than two decades, Statistics in the Pharmaceutical Industry has been the definitive guide to sorting through the challenges in the industry, and this Third Edition

• Author : Dennis Cosmatos,Shein-Chung Chow
• Publisher : CRC Press
• Release : 17 December 2008

Examines Critical Decisions for Transitioning Lab Science to a Clinical Setting The development of therapeutic pharmaceutical compounds is becoming more expensive, and the success rates for getting such treatments approved for marketing and to the patients is decreasing. As a result, translational medicine (TM) is becoming increasingly important in the healthcare industry – a means of maximizing the consideration and use of information collected as compounds transition from initial lab discovery, through pre-clinical testing, early clinical trials, and late confirmatory studies