A New York Times report says 80 per cent of the new drugs that the US Food & Drug Administration approved in 2008 were tested outside the US and 78 per cent of all the subjects or participants in the trials were enrolled outside the US. Ten medicines were tested entirely outside with no American participants.
While western Europe was the location for most subjects and sites, Central and South America had the highest number of subjects per sites.
The NYT piece was based on a report by the inspector general of the Department of Health and Human Services.
“As sponsors increase the number of foreign clinical trials in support of F.D.A. marketing applications, the agency’s current method of using inspections to ensure human subject protections and data validity is becoming increasingly strained,” the article quoted the inspector general Daniel Levinson, as saying.
“The FDA inspected just 0.7 per cent of foreign clinical trial sites vs 1.9 per cent of domestic sites. the F.D.A. was unable to provide Mr. Levinson’s investigators with detailed clinical trial data for 29 of the 129 of the approved applications in 2008. For eight of the applications, the agency could not locate any part of the application”, the NYT wrote.
Levinson has reportedly suggested that the agency demand that drug companies submit their applications in a standardized electronic format. A database controlled by the F.D.A. of foreign clinical trial sites would help identify sites and investigators for audits, he wrote, according to NYT.
The report provides evidence of what has long been suspected. It also is a timely warning for India which recently made the registration of clinical trials mandatory. Last heard, the Indian drugs regulator was attempting to finalise a template for the submission of clinical trials information for a web-based database ctri.in that the industry accepts and which also captures all the necessary information. If this isn’t done, it needs to expedite this in consultation with the industry.
Also, until the Indian regulator is able to create the resources and skill sets to reliably audit clinical trials it should work together with the FDA to figure out a manner in which FDA officials can be alerted in case of concerns emerging at a particular site or regarding specific investigators.
There is already some amount of co-operation between the DCGI and the FDA for training auditors. But that’s simply not sufficient given the scale of drug trials being undertaken here.