In a recent article in the New York Times by Daniel R Levinson it was pointed out that there is concern over the lack of oversight by the FDA with regard to foreign Clinical Trials. The countries that have experienced the largest influx/growth in the initiation of clinical trials are in Eastern Europe, Latin America, South America and India. The FDA inspects less than 1% of clinical trial sites outside the US; this is troubling since 48% of all subjects who participated in clinical trials were enrolled at investigational sites outside the US.
“The FDA or USFDA is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments, responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics“. However, it appears that the FDA cannot assure the same level of human subject protection in non US clinical trials as compared to US-based ones which is of course concerning especially since it was reported that some drugs sold in the US were entirely tested outside the US and as stated previously, a large percentage of subjects who participated in clinical trials were enrolled at investigational sites outside of the US.
Sponsors need to provide sufficient oversight as well. Sponsors should educate non-US investigational staff on the Guidelines for Good Clinical Practices particularly in those countries where experience with the Guidelines is questionable and when the clinical trial is not conducted under an Investigational New Drug (IND) Application. Also, sponsors can play more of an active role in auditing/monitoring investigational sites besides what the Clinical Research Associate (CRA) is charged with doing.
Daniel Levinson stated in his article “as Sponsors increase the number of foreign clinical trials in support of FDA marketing applications, the agency’s current method of using inspections to ensure human subject protection and data validity is becoming increasingly strained”.