A report issued by the Department of Health and Human Services on the globalization of clinical research is creating quite a bit of buzz. Unfortunately, it's not really the good kind of buzz...
Challenges to FDA's Ability To Monitor and Inspect Foreign Clinical Trials [PDF link] contains nuggets like:
We found that 80 percent of approved marketing applications for drugs and biologics contained data from foreign clinical trials.And:
We found that in fiscal year 2008, sponsors relied heavily on data from foreign clinical trials to support their marketing applications for drugs and biologics.These issues aren't really new [PDF link] - so what's the big deal? Why is this now "a very frightening and appalling situation"?
One reason for concern is that FDA inspected only 0.7% of foreign clinical trial sites, according to the same report. According to consumer group Public Citizen, the report "confirms some of the worst fears about the serious dangers of the escalating globalisation of human experimentation". Strong words indeed.
Drug manufacturers and CROs, on the other hand, argue that rising costs are a real issue and, anyway, it's too difficult to get trials off the ground in the U.S. There may be something to this argument: According to the report, the region that appeared most popular for conducting overseas trials was Western Europe. Central and South America was the favorite location when sponsors sought large numbers of participants per site.
The report contained three recommendations to FDA:
- Require standardized electronic clinical trial data and create an internal database from which FDA can select sites for inspection
- Monitor trends in foreign clinical trials not conducted under INDs and take steps as necessary to encourage sponsors to file INDs
- Explore additional ways to expand the FDA's oversight of foreign clinical trials, including agreements with foreign regulatory bodies and inspections of clinical trial sites in countries not previously inspected
- Clinical trials in Latin America
- Global clinical research - unethical or business necessity?
- Clinical research continues to shift east
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