2_Seth Glickman et al, Ethical and Scientific Implications of the Globalization of Clinical Research

2_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 817 sounding Board cost to develop a new drug averaged $802 million, with time costs accounting for half of that amount. 13 The large pool of potential research participants and the lower cost of research in countries such as China and India provide oppor- tunities to accelerate recruitment. 6,14,15 Clinical testing in developing countries is also attractive to pharmaceutical and device companies because it can help them overcome regulatory barriers for drug approval in these countries in which the pop- ulation size alone offers the promise of expanding markets. 16 Widespread adoption of the Interna- tional Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice (ICH-GCP) guidelines and stronger intellectual property pro- tections in developing countries may also have contributed to the globalization of clinical re- search.
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