Authors:
James Willson
Title
Challenges of monitoring international trial sites
Disclaimer: The views and opinions expressed in this article are those of the author and do not necessarily reflect the official policy or position of Shire Pharmaceuticals.
Abstract
Sponsor companies generally conduct clinical trials at multiple trial sites across many regions of the world. As of March 2012, Clinical trials.Gov reported that there were over120,000 trials being conducted in 179 countries.
Monitoring of site conduct during these clinical trials is a requirement of International Conference on Harmonization – Good Clinical Practice (ICH GCP) to ensure the safety of subjects and integrity of the scientific data being collected. This globalization of clinical trials therefore creates numerous challenges for sponsors and their vendors to ensure the principles of ICH-GCP are adhered to.
Cultural differences, languages, time zones, different medical treatment practices for conditions/disease, varying clinical trial experience, differences in country rules and regulations, and varying access to and availability of different technologies across the world all contribute to the challenges of setting up and running these global clinical trials.
This presentation will review potential ways in which Sponsor companies, Clinical Research Organisations (CROs) and other vendors can work together to understand and overcome such challenges in order to ensure consistency is maintained across all sites.