Description

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

Readership

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

Dedication

International Editorial Advisors

Contributors

Section 1 Clinical Trials

Chapter 1. Introduction

Chapter 2. Global Clinical Trials

Introduction

Principles of Clinical Study Design

REFERENCE

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

Introduction

Status of Clinical Trials in Africa

Site Management Structures

Current Funding Models and Impact on Implementation of Studies

Building Additional Capacity

Establishing New Sites

REFERENCES

Chapter 4. Clinical Trial Sites Capabilities

Introduction

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

Conclusion

REFERENCES

Chapter 5. How to Select and Oversee Contract Research Organizations

Introduction

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

REFERENCES

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

REFERENCES

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

Details

No. of pages:
320
Language:
English
Copyright:
© 2012
Published:
Imprint:
Academic Press
Print ISBN:
9780124157873
Electronic ISBN:
9780124158603

About the authors

Menghis Bairu

Menghis Bairu, M.D.—physician, editor, author, philanthropist and healthcare business executive—has more than two decades of international experience in the biotechnology, pharmaceutical, global health and non-profit arenas. Dr. Bairu serves as Executive Vice President, Chief Medical Officer and Head of Global Development at Elan. His responsibilities include, but are not limited to clinical development, biometrics, regulatory, CMC, QA, safety-and-risk management, clinical operations and medical affairs. Previously he served as head of Onclave Therapeutics, a wholly Elan-owned oncology biotech company. He lectures extensively on global health and biopharmaceutical issues with particular focus on Emerging Markets (e.g. India, China, Latin America, Singapore, Middle East, South East Asia and Africa). He served as editor and co-author of Global Clinical Trials: Effective Implementation and Management (Elsevier, 2011), a textbook designed to help researchers develop and implement effective and ethical international clinical trials. Dr. Bairu is also editor/co-author of Global Clinical Trials Playbook: Management and Implementation (Elsevier, 2012), and Global Clinical Trials for Alzheimer's Disease: Design, Implementation, and Standardization (Elsevier, 2013). Prior to joining Elan, Dr. Bairu worked at Genentech for more than five years in a number of managed care, medical and commercial (Oncology, Immunology, and Cardiovascular) roles. He served as managed care Medical Director for Fremont Health Corporation/II before joining Genentech. He served on the board of directors for One World Health, a nonprofit drug development company funded by the Bill and Melinda Gates Foundation and A-Cube, a privately held pharma startup. In 2013, Dr. Bairu was named to the boards of directors of Dubai-based NewBridge Pharmaceuticals (he also serves as chairman of NewBridge’s science and technology committee), and ADVentura Capital SL, a Barcelona, Spain-based venture capita

Affiliations and Expertise

President and CEO, Speranza Therapeutics, Dublin, Ireland and Chief Medical Officer and Head of Global Development, Elan Pharmaceuticals, Cambridge, Massachusetts

Richard Chin

Richard Chin is the CEO of Institute for OneWorld Health, the first U.S. nonprofit pharmaceutical company and Associate Professor at UCSF School of Medicine. OneWorld Health develops affordable drugs for neglected patients in the developing world. Dr. Chin has extensive expertise in drug development, including over 45 INDs and almost a dozen drug registrations. His previous roles include CEO of a NASDAQ listed company, Senior Vice President of Global Development at Elan, and Head of Clinical Research for the Biotherapeutics Unit at Genentech. He was named by Businessweek in 2006 as one of the youngest 99 public company CEOs in the United States. Dr. Chin earned an M.D. from Harvard and the equivalent of a J.D. from Oxford, where he studied as a Rhodes Scholar.

Affiliations and Expertise

CEO, Oxigene San Francisco, CA, USA

Reviews

"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 & 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.