Global Clinical Trials for Alzheimer’s Disease: Chapter 4. Overview of Global Clinical Trials: Drivers/Issues/Opportunities of Globalization

Global Clinical Trials for Alzheimer’s Disease: Chapter 4. Overview of Global Clinical Trials: Drivers/Issues/Opportunities of Globalization
ISBN-10
0128070390
ISBN-13
9780128070390
Series
Global Clinical Trials for Alzheimer’s Disease
Category
Medical
Pages
432
Language
English
Published
2013-08-28
Publisher
Elsevier Inc. Chapters
Authors
Richard Chin, Menghis Bairu, Sidney A. Spector

Description

A rapid increase in the globalization of clinical trials is being driven by a need for lower cost, greater speed, and higher quality. Increasing costs—approximately 20% per year—account for much of this effort. Trials in developing countries—done with rigorous controls and safeguards—can lower the cost of drugs, distribute modern science and medicine, and enhance the health of patients around the world. Lesser developed countries offer a large pool of willing, treatment-naïve patients. Globalization of clinical trials introduces potential issues: for example, ethical concerns, harmonization, logistical challenges. Researchers must take into account potential ethnic, genetic, and other differences which can make extrapolation from one geographical region to another problematic. Differences between populations and geographies are divided into intrinsic and extrinsic differences. Historically, these differences have not resulted in changes to the risk–benefit ratio of outsourcing clinical trials.

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