6_Seth Glickman et al, Ethical and Scientific Implications of the Globalization of Clinical Research

6_Seth Glickman et al, Ethical and Scientific Implications of the Globalization of Clinical Research

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n engl j med 360;8 nejm.org february 19, 2009 821 sounding Board Table 2. Issues and Proposed Solutions for the Globalization of Clinical Research.* Issue Problem Proposed Solutions Selection of patients in mul- tinational trials Research in communities that are not intended to be major markets for the products under testing can be ethically problematic. Sponsors need to describe how trial populations match their intended markets for the drugs or medical devices being tested. Create target enrollment of patients according to geographic region on the basis of the in- tended use of the product, similar to FDA and NIH policies for target enrollment of women and minorities in clinical trials. Transparency of clinical trial results in developing countries Protection of publication rights and access to trial data for investigators is necessary to preserve the integrity of re- search. Publish all clinical trial data regardless of the location of research, and reinforce these re- quirements according to the FDA Amendments Act of 2007. Preserve publication rights of investigators globally, independent of sponsors, through le- gal agreements at the onset of the clinical trial. Create mechanisms for leadership of clinical trials that incorporate representatives of key
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This note was uploaded on 10/10/2010 for the course ENG 000121 taught by Professor Mcgrand during the Spring '10 term at Cornell University (Engineering School).

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