A Guide for the Ethics Committee
A Case Study: Refining Clinical Research Infrastructure
The Office of Inspector General, US Department of Health and Human Services has recently reported that over half of clinical trial subjects and sites were located outside the United States (based on 2008 US FDA approved drugs).
Our analyses of the US trial registry shows slightly different results with relatively more sites for emerging trial regions; East Europe - 6.4% for the Report and 11.0% for the registry data. The figure for Asia goes in the same direction, i.e. 3.4% versus 7.6%.
The industry has decided to go global due to the lack of investigators and study participants in North America and Europe. This trend will most certainly continue and a large portion of the trials are not overseen by the US FDA.
In this Magnifier issue, we cover several aspects of US FDA oversight of clinical trials based on the US trial registry database and the US FDA investigator database. In short, the industry continues to go global; the best performing sites are located outside the US and Europe; the vast majority of industry-sponsored trials conducted in the US are overseen by the US FDA, while this is not the case for such trials that omit US participation.
The second Clinical Trial Magnifier Conference will tentatively be held on November 24-26, 2010 in Kota Kinabalu, Sabah, Borneo, Malaysia. The Conference focus will be clinical investigator incentives for participation in industry-sponsored clinical trials. For preliminary registration and more details about the Conference, please visit our conference website at www.ctmconference.com for more information.
Continuing with the aim of the 4S Project, to develop site-specific SOPs that can be adapted to any study site, three Trial Operation SOPs have been included in this issue. Collaborating with the 27 members of the project, who come from the pharmaceutical industry, health care organizations, and the academia, the published SOPs are currently under review.
The Subscribers' Blog is currently under construction, but it is tentatively planned to be launched soon. The first planned topic to be discussed amongst the members is "Incentives for Investigators in Clinical Trials."
Please return shortly for the discussion.