Global Clinical Trials: Effective Implementation and Management,

Citation

(2011), "Global Clinical Trials: Effective Implementation and Management,", International Journal of Health Care Quality Assurance, Vol. 24 No. 7. https://doi.org/10.1108/ijhcqa.2011.06224gaa.013

Global Clinical Trials: Effective Implementation and Management,

Global Clinical Trials: Effective Implementation and Management

Article Type: Recent publications From: International Journal of Health Care Quality Assurance, Volume 24, Issue 7

Richard Chin and Menghis BairuAcademic Press2011ISBN-10: 0123815371ISBN-13: 978-0-123-81537-8

Keywords: Global clinical trials, Clinical research, Clinical study logistics

This book will explore the great opportunities and challenges that 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.

Contents include:

1. 1.

   Introduction.

2. 2.

   Overview:

   • •

     background;

   • •

     ethics;

   • •

     regulatory and legal requirements;

   • •

     US regulations;

   • •

     use of foreign clinical data for FDA and EMEA;

   • •

     WHO and prequalification; and

   • •

     regulatory filings.

3. 3.

   Special considerations and regulations in developing countries.

4. 4.

   Clinical study logistics:

   • •

     design of clinical trials for developing countries;

   • •

     study management, planning and project management;

   • •

     logistics, protocol writing, investigators brochure writing Chapter 18: site selection and capacity building;

   • •

     study conduct and monitoring; and

   • •

     data collection and management.

5. 5.

   Specific diseases and types of studies:

   • •

     vaccine trials;

   • •

     TB trials;

   • •

     HIV trials;

   • •

     oncology trials; and

   • •

     diabetes trials.

6. 6.

   Case studies.