4_Seth Glickman et al, Ethical and Scientific Implications of the Globalization of Clinical Research

4_Seth Glickman et al, Ethical and Scientific Implications of the Globalization of Clinical Research

Info iconThis preview shows page 1. Sign up to view the full content.

View Full Document Right Arrow Icon
n engl j med 360;8 nejm.org february 19, 2009 819 sounding Board to participation in study design, access to data, and control over the publication of results. 41 Pro- tection of publication rights for investigators is necessary to the transparency and integrity of re- search, yet it is an ongoing area of contention for industry sponsors. 42,43 Investigators in developing countries are generally less experienced and less familiar with these guidelines and, therefore, less likely to have access to trial data or to publish results. 44,45 To what extent should people in developing countries be enrolled in clinical trials? Clinical re- search should be responsive to the health needs and priorities of the communities in which the research is conducted. 46 Given the increasing global prevalence of conditions such as cardio- vascular disease, it will be important to test drugs and devices on a global scale. However, among the ongoing phase 3 clinical trials that we ex- amined that were sponsored by U.S.-based com- panies in developing countries, none were trials of diseases such as tuberculosis that dispropor- tionately affect the populations of these countries. In contrast, we found a variety of trials in devel- oping countries for conditions such as allergic rhinitis and overactive bladder. Developing coun-
Background image of page 1
This is the end of the preview. Sign up to access the rest of the document.

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).

Ask a homework question - tutors are online