E-drug: Clinical Trials in Developing Countries
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I have posted a concentration paper by one of our students Dina Mirpuri. The
title is: Ethical and Management Considerations of Conducting International
Clinical Trials in Developing Countries. The URL is: Watch for word
wrapping!
http://dcc2.bumc.bu.edu/richardl/IH820/Resource_materials/Dina-CRO-Dev_count
ries-051102.doc
Her e-mail address is Dina Mirpuri [d_mirpuri@hotmail.com]
What is different in this paper is the emphasis she places on management
issues in running clinical trials in developing countries. Most existing
literature focuses on ethical issues and while these are addressed in the
paper the management issues get due prominence.
Here is the abstract:
Pharmaceutical companies are expanding their clinical focus beyond the U.S.
to include lesser-developed countries. Although this transition is to be
expected because trials should be conducted in the setting that the diseases
being studied are prevalent, there are very serious ethical and management
issues to consider. Should the same ethical standards that are applied to
clinical trials in the U.S. be transferred to the host country? Do
international clinical trials have unique ethical issues that need to be
looked at? What does an American Contract Research Organization (CRO) need
to be aware of prior to embarking on such a trial?
Simply because the host country lacks the amenities that a U.S. site may
afford, does not mean that the country cannot participate in the trial.
There are basic requirements that the site must be able to meet, ie.
diagnostic accuracy and data collection. If the site can meet the defined
minimum criteria, then the remaining tasks can be managed by the sponsor
pharmaceutical company and CRO.
Despite the obstacles and hurdles that there are to conducting international
clinical trials, it is worth investing the time to detail the specific
requirements. A poorly managed trial is inherently unethical. There is
much to be gained for the host country, the pharmaceutical company and the
CRO conducting the trial, provided it is managed in a fashion that allows
all parties to achieve their goal.
This paper is written for both an American CRO and for developing country
regulators, so that the issues around conducting clinical trails in
developing countries can be examined from all perspectives.
Richard Laing
Associate Professor of International Health
Boston University School of Public Health
715 Albany St, T4W, Boston MA 02118 USA
Tel 617 414-1444 Fax 617 638-4476
E-mail richardl@bu.edu
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