Global clinical trials playbook : management and implementation when resources are limited / edited by Menghis Bairu, Richard Chin.

Format:

Book

Contributor:

Bairu, Menghis.

Chin, Richard Y. (Richard Yoonsik)

Language:

English

Subjects (All):

Clinical trials--Handbooks, manuals, etc.

Clinical trials.

Human experimentation in medicine--Handbooks, manuals, etc.

Human experimentation in medicine.

Clinical Trials as Topic.

Developing Countries.

Medical Subjects:

Clinical Trials as Topic.

Developing Countries.

Genre:

Handbooks and manuals.

Physical Description:

1 online resource (xii, 310 pages, 8 pages of plates) : illustrations

Place of Publication:

London : Academic Press, 2012.

System Details:

Mode of access: World Wide Web.

text file

Summary:

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.

Contents:

Section 1. Clinical trials. Chapter 1. Introduction

Chapter 2. Global clinical trials: study design and planning

Chapter 3. Building a healthy mechanism for good clinical practice-compliant global trials: African perspectives

Chapter 4. Clinical trial sites capabilities: standard operating procedure implementation in effective African models

Chapter 5. How to select and oversee contract research organizations

Chapter 6. The how-to of global clinical trial forecasting, budgeting, and project management

Section 2. Strengthening and building clinical trial site capabilities and capacity in developing and emerging markets. Chapter 7. Lessons learned in India

Chapter 8. Lessons learned in China

Chapter 9. Lessons learned in Eastern Europe

Chapter 10. Lessons learned in Singapore

Chapter 11. Lessons learned in Turkey

Section 3. Regulatory capacity. Chapter 12. Development of regulatory capacity in monitoring, oversight, enforcement, and approval of clinical trials: Taiwan's experience as an example

Section 4. How to build and enhance pharmacovigilance and risk management capacity and capability. Chapter 13. Pharmacovigilance and risk management

Section 5. Electronic data capture. Chapter 14. Setting up electronic data capture capabilities

Section 6. Ethics, human resources, and intellectual property. Chapter 15. Ethics and institutional review board capacity building

Section 7. Quality assurance and data management. Chapter 16. Clinical quality assurance and data management

Appendix A. Sample protocol template

Appendix B. Sample informed consent form

Appendix C. Sample case report form

Appendix D. Sample statistical analysis plan

Appendix E. Case report form versioining policy

Appendix F. Checklist for study close-out

Appendix G. Financial disclosure form

Index

Color plates.

Notes:

Title from pdf title page (viewed July 11, 2012).

Includes bibliographical references and index.

OCLC:

789137615

Access Restriction:

Restricted for use by site license.