The globalization of clinical drug development

Industry-sponsored clinical research of investigational drugs (also called clinical development) has traditionally been carried out in relatively developed countries in the North American, Western European, and Pacific regions. However, lately it has been widely reported that clinical trials starting now are becoming increasingly diffused globally, with significant growth of activity in so-called emerging economies in Eastern Europe, Latin America, and Southeast Asia. This change in location of clinical development activities has numerous implications for patients, health care providers, pharmaceutical companies, regulatory agencies and governments around the globe. Even though there is much debate about the topic, a public systematic quantitative assessment of the current status of the globalization of clinical drug development phenomenon is lacking. The objective of this thesis research is to provide such objective quantification while addressing some issues that are currently in active discussion. This thesis documents that the participation of emerging countries is still relatively small (13%) and they most commonly participate in very large (involving more than five countries) phase Ilb or III trials.

Department dc:contributor.department

Harvard University--MIT Division of Health Sciences and Technology.

Grantor dc:publisher

Massachusetts Institute of Technology

Year dc:date.issued

2006

Author dc:creator

• Thiers, Fabio Albuquerque

Advisor dc:contributor.advisor

• Ernst Berndt and Anthony Sinskey.

• Harvard University--MIT Division of Health Sciences and Technology.

Statement dc:rights

• M.I.T. theses are protected by copyright. They may be viewed from this source for any purpose, but reproduction or distribution in any format is prohibited without written permission. See provided URL for inquiries about permission.

Licence dc:rights.uri

• http://dspace.mit.edu/handle/1721.1/7582

Language dc:language.iso

eng

Handle dc:identifier.uri

http://hdl.handle.net/1721.1/35556

OAI identifier oai:identifier

oai:dspace.mit.edu:1721.1/35556