Global Clinical Trials Playbook

1st Edition

Capacity and Capability Building

Print ISBN: 9780124157873
eBook ISBN: 9780124158603
Imprint: Academic Press
Published Date: 20th April 2012
Page Count: 320
93.95 + applicable tax
75.00 + applicable tax
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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. 

Key Features

  • Gives medical professionals the business tools needed to effectively execute clinical trials throughout the world
  • Provides real world international examples which illustrate the practical translation of principles
  • Includes forms, templates, and additional references for standardization in a number of global scenarios


Professionals in biotechnology and pharmaceutical companies, government, NGOs, contract research organizations and foundations including physicians, regulators, safety officers, clinical coordinators, data managers, and business managers who are planning and executing clinical trials in developing countries

Table of Contents


International Editorial Advisors


Section 1 Clinical Trials

Chapter 1. Introduction

Chapter 2. Global Clinical Trials


Principles of Clinical Study Design


Chapter 3. Building a Healthy Mechanism for Good Clinical Practice-Compliant Global Trials


Status of Clinical Trials in Africa

Site Management Structures

Current Funding Models and Impact on Implementation of Studies

Building Additional Capacity

Establishing New Sites


Chapter 4. Clinical Trial Sites Capabilities


Role of Standard Operating Procedures in Clinical Research

Standard Operating Procedures, Policies, Guidelines, and Study-Specific Procedures

Suggested List of Standard Operating Procedures

Logistics Associated with Standard Operating Procedure Implementation



Chapter 5. How to Select and Oversee Contract Research Organizations


Perspective of Working with Global and Niche Contract Research Organizations

Understanding Your Options when Outsourcing an Overseas Trial

Comparing the Capabilities of Global and Niche Contract Research Organizations to Support Clinical Trials

Assessing the Benefits of International Reach Versus Local Knowledge

Examining Quality and Relationship Management to Finalize Contract Research Organization Selection


Chapter 6. The How-To of Global Clinical Trial Forecasting, Budgeting, and Project Management

Recent Trends in Clinical Trials

Clinical Trial Forecasting

Clinical Trial Budgeting

Clinical Trial Project Management


Section 2 Strengthening and Building Clinical Trial Site Capabilities and Capacity in Developing and Emerging Markets</p


No. of pages:
© Academic Press 2012
Academic Press
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"Contributors mostly from outside of Europe and the US explore various elements required for successfully implementing clinical trials in poor countries that will be used as evidence to license drugs in rich countries." --Reference and Research Book News, August 2013

"The book brings together a panoply of academics, registration professionals, safety officers and other experts from the pharmaceutical industry and CROs… [and] uses real-life examples to present the tools available to build and enhance human capacity in order to execute clinical trials throughout the world, and is recommended for anybody interested in expanding their knowledge of international clinical trials." --Samedan LTD Pharmaceutical Publishers, Autumn 2012

"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 and 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, FAM