Global Clinical Trials Playbook
Management and Implementation when resources are limited
Edited by- Menghis Bairu, Executive Vice President and General Manager, Elan Pharmaceuticals, South San Francisco, CA, USA
- Richard Chin, CEO, Oxigene San Francisco, CA, USA
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.
Hardbound, 320 Pages
Published: April 2012
Imprint: Academic Press
ISBN: 978-0-12-415787-3
Reviews
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Global Clinical Trials: Effective Implementation and Management is probably the most comprehensive book written to date on the topic. In 2008, 97 (80%) of 121 FDA marketing applications for drug and¿biological products included non-U.S. data, including 10 (8%) with no U.S. data. The book includes contributions¿from 59 authors, with coverage of¿many countries engaged in clinical research"--Clinical Research Best Practices"This is indeed a valuable resource with a broad range of regional experiences in clinical trials and touching a wide array of topics increasing the potential of target readers. I have truly found it quite informative." Dr. Michael Makanga, Director South-South Cooperation and Head of Africa Office, European & Developing Countries Clinical Trials Partnership (EDCTP), South Africa "Global Clinical Trials Playbook is a treatise in self-learning, and a must read for researchers in academia, CROs, and NGOs involved in funding and conducting clinical trials. It is a vital reference for those interested in capacity building in clinical research, especially in developing countries." Professor S. D. Seth, MD, FAMS, FNASc, FIPS, FCAI, FISCD, Advisor of Clinical Trials Registry - India, National Institute of Medical Statistics, Indian Council of Medical Research, New Delhi, India "This is an important book that comprehensively addresses capacity building across the globe. The breadth of the book and the broad array of geographies covered are impressive. This is a major publication that will push the field forward." Dr. Dan Zhang, MD, PhD, Chairman & CEO of Fountain Medical Group, Shangai, China "Dr. Bairu and colleagues have produced the definitive reference guide to undertaking clinical trials around the world. I am sure that the Global Clinical Trials Playbook will instantly become an indispensable resource for funders and organisers of clinical trials who wish to stay up to date with the latest thinking in this fast moving field." Dr. Rubin Minhas, M.B.Ch.B, Editor-in-Chief: Clinical Evidence, Best Practice & Clinical Director, BMJ Evidence Centre "This book covers a broad range of topics important in global clinical trials and will be a welcome and comprehensive resource for professionals who are engaged in clinical trial related capacity building. It is a practical guide to conduct clinical trials in the new and uprising parts of the drug development world including Eastern Europe, Turkey, Singapore, India and China. The book goes hand in hand with global efforts to develop one global training concept for global drug development, the PharmaTrain Project. Learning by reading and doing for improved competency." Fritz R. Bühler, Coordinator of IMI PharmaTrain, University of Basel, SwitzerlandCarl C. Peck, University of California San Francisco, UCSF, USABoth Founders of the European, American and Chinese Courses in Drug Development and Regulatory Sciences
Contents
- Chapter 1- Introduction
Chapter 2- Global Clinical Trials: study design and planning
Chapter 3- Building a healthy mechanism for GCP compliant global trials: African perspectives
Chapter 4- Clinical Trial sites capabilities: effective African models
Chapter 5- Strengthening / building clinical trial site capabilities and capacity in developing/emerging markets.
Chapter 6- How to select and oversee CROs
Chapter 7- How to prioritize CTs based on national interest
Chapter 8- The How to of Global Clinical Trial Forecasting, Budgeting, and Project Management
Chapter 9- How to build-enhance Regulatory capacity to evaluate INDs and NDAs
Chapter 10- Development of regulatory capacity in Monitoring, Oversight, Enforcement and approval of Clinical Trials
Chapter 11- PharmacoVigilance and Risk Management
Chapter 12- Setting up EDC capabilities
Chapter 13- Ethics and IRB capacity building
Chapter 14- Human resources planning and Job Descriptions
Chapter 15- Ensuring intellectual property protection
Chapter 16- Clinical Quality Assurance and Data Management
Appendices
