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Books in Clinical trials

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Global Clinical Trials Playbook

  • 1st Edition
  • April 20, 2012
  • Menghis Bairu + 1 more
  • English
  • Hardback
    9 7 8 - 0 - 1 2 - 4 1 5 7 8 7 - 3
  • eBook
    9 7 8 - 0 - 1 2 - 4 1 5 8 6 0 - 3
Pharmaceuticals companies, biotech companies, and CROs, regardless of size, all face the same challenge of managing costs and operational execution associated with bringing a valuable drugs and devices to market. Because of timeline pressures and cost as well as the growing interest in "neglected diseases" and diseases affecting the emerging nations, clinical trials are increasingly conducted in emerging markets and developing countries where infrastructure, leadership, skilled personnel and a governance are at a premium. Working with academics, regulatory professionals, safety officers, experts from the pharma industry and CROs, the editors have put together this up-to-date, step-by-step guide book to building and enhancing global clinical trial capacity in emerging markets and developing countries.  This book covers the design, conduct, and tools to build and/or enhance human capacity to execute such trials, appealing to individuals in health ministries, pharmaceutical companies, world health organizations, academia, industry, and non-governmental organizations (NGOs) who are managing global clinical trials. 

Clinical Trials

  • 1st Edition
  • October 25, 2011
  • Tom Brody
  • English
  • eBook
    9 7 8 - 0 - 1 2 - 3 9 1 9 1 3 - 7
Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines is a practical guidebook for those engaged in clinical trial design. This book details the organizations and content of clinical trials, including trial design, safety, endpoints, subgroups, HRQoL, consent forms and package inserts. It provides extensive information on both US and international regulatory guidelines and features concrete examples of study design from the medical literature. This book is intended to orient those new to clinical trial design and provide them with a better understanding of how to conduct clinical trials. It will also act as a guide for the more experienced by detailing endpoint selection and illustrating how to avoid unnecessary pitfalls. This book is a straightforward and valuable reference for all those involved in clinical trial design.

Strategy and Statistics in Clinical Trials

  • 1st Edition
  • June 26, 2011
  • Joseph Tal
  • English
  • Hardback
    9 7 8 - 0 - 1 2 - 3 8 6 9 0 9 - 8
  • eBook
    9 7 8 - 0 - 1 2 - 3 8 6 9 9 2 - 0
Strategy and Statistics in Clinical Trials deals with the research processes and the role of statistics in these processes. The book offers real-life case studies and provides a practical, how to guide to biomedical R&D. It describes the statistical building blocks and concepts of clinical trials and promotes effective cooperation between statisticians and important other parties. The discussion is organized around 15 chapters. After providing an overview of clinical development and statistics, the book explores questions when planning clinical trials, along with the attributes of medical products. It then explains how to set research objectives and goes on to consider statistical thinking, estimation, testing procedures, and statistical significance, explanation and prediction. The rest of the book focuses on exploratory and confirmatory clinical trials; hypothesis testing and multiplicity; elements of clinical trial design; choosing trial endpoints; and determination of sample size. This book is for all individuals engaged in clinical research who are interested in a better understanding of statistics, including professional clinical researchers, professors, physicians, and researchers in laboratory. It will also be of interest to corporate and government laboratories, clinical research nurses, members of the allied health professions, and post-doctoral and graduate students.

Principles and Practice of Clinical Trial Medicine

  • 1st Edition
  • June 18, 2008
  • Richard Chin + 1 more
  • English
  • Hardback
    9 7 8 - 0 - 1 2 - 3 7 3 6 9 5 - 6
  • eBook
    9 7 8 - 0 - 0 8 - 0 5 5 7 9 3 - 9
Clinical trials are an important part of medicine and healthcare today, deciding which treatments we use to treat patients. Anyone involved in healthcare today must know the basics of running and interpreting clinical trial data. Written in an easy-to-understand style by authors who have considerable expertise and experience in both academia and industry, Principles and Practice of Clinical Trial Medicine covers all of the basics of clinical trials, from legal and ethical issues to statistics, to patient recruitment and reporting results.