Global Clinical Trials

Effective Implementation and Management
Erscheinungsjahr 2016
ISBN: 978-0-12-810355-5
Verlag: William Andrew Publishing

Buch, Englisch, 522 Seiten, Format (B × H): 152 mm x 229 mm, Gewicht: 860 g

This book will explore the great opportunities and challenges which exist in conducting clinical trials in developing countries. By exploring the various regulations specific to the major players and providing insight into the logistical challenges including language barriers, this book provides a working tool for clinical researchers and administrators to navigate the intricacies of clinical trials in developing countries. Important topics such as ethical issues will be handled very carefully to highlight the significant differences of conducting this work in various jurisdictions. Overall, it will present a clear and comprehensive guide to the ins-and-outs of clinical trials in various countries to assist in design, development, and effectiveness of these trials.

Zielgruppe

<p>Physicians, clinical coordinators, biostatisticians, and data managers employed at academic medical centers, pharmaceutical companies, biotechnology companies, medical device companies, contract research organizations, and product development partnerships (non-profit pharmaceutical companies) who are interested in planning and executing clinical trials in developing countries</p>

Autoren/Hrsg.

Chin, Richard

Bairu, Menghis

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Public Health, Gesundheitsmanagement, Gesundheitsökonomie, Gesundheitspolitik
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Biomedizin, Medizinische Forschung, Klinische Studien
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Medizinische Mathematik & Informatik
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Krankenhausmanagement, Praxismanagement

Inhaltsverzeichnis

Section I: Overview

Chapter 1 Background

Chapter 2: Ethics
Chapter 3: Regulatory and Legal Requirements
Chapter 4: United States Regulations
Chapter 5: Indian Regulations
Chapter 6: Chinese Regulations
Chapter 7: African Regulations
Chapter 8: Middle Eastern Regulations
Chapter 9: Southeast Asian Regulations
Chapter 10: South American Regulations
Chapter 11: WHO and prequalification

Section II: Clinical Study and Logistics
Chapter 12: Design of Clinical Trials
Chapter 13: Study Management
Chapter 14: CRO Qualification, Selection, and Management
Chapter 15: Logistics
Chapter 16: Partner Management
Chapter 17: Site Selection and Capacity Building
Chapter 18: Study Conduct and Monitoring
Chapter 19: Data Collection and Management

Section III: Special Considerations in Conducting Trials in Developing Countries
Chapter 20: Conducting Studies in India
Chapter 21: Conducting Studies in China
Chapter 22: Conducting Studies in Africa
Chapter 23: Conducting Studies in Eastern Europe
Chapter 24: Vaccine Trials

Section IV: Analysis of Results

Chapter 25: Basic Statistics

Chapter 26: Data Analysis

Chapter 27: Confounding, Interactions, and Multivariate Analysis

Chapter 28: Common Misinterpretations

Chapter 29: Regulatory Filings

Section V: Appendices

Appendix A: Sample Protocol

Appendix B: Sample Consent Form

Appendix C: Sample Investigator’s Brochure

Appendix C: Sample Case Report Form

Appendix D: Sample Statistical Analysis Plan

Appendix D: ICH Guideline

Appendix E: Glossary

Über Autor(innen)

Bairu, Menghis
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 capital firm focused on funding and mentoring promising healthcare, IT and GreenTech companies. In 2011, Dr. Bairu joined the advisory board of the China Trials 5, a global clinical trials development summit focusing on China and north Asia. He currently serves as Adjunct Faculty at the University of California San Francisco School of Medicine where he lectures on global clinical trials’ design, development and conduct.

Chin, Richard
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.