The US Department of Health and Human Services has issued a report highlighting the lack of monitoring and inspections of foreign clinical trials carried out by the Food and Drug Administration.

The analysis states that sources have estimated that between 40%-65% of clinical studies investigating FDA-regulated products are run outside the USA, as drugmakers benefits of lower costs and “the ability to conduct larger trials in less time”. However the government says that critics have raised concerns about the increased prevalence of foreign clinical trials, particularly those conducted in developing countries.

Those concerns include the ability of local regulatory bodies and institutional review boards to adequately monitor trials to protect the rights and welfare of subjects and to ensure data integrity. The report says that some observers “question the extent to which the results from foreign clinical trials conducted in developing countries are generalisable to the US population”.

Against this backdrop, the report looks at data from full-year 2008 which shows that 80% of approved marketing applications for drugs and biologics contained data from foreign clinical trials. The FDA inspected 1.9% of domestic trial sites but just 0.7% of foreign sites.

The HHS has made recommendations saying that the FDA should require standardised electronic clinical trial data and create an internal database. It should monitor trends in foreign clinical trials not conducted under Investigational New Drug Applications “and, if necessary, take steps to encourage sponsors to file INDs,” the government says.

The report adds that the FDA should continue to develop inspectional agreements with foreign regulatory bodies inspect clinical trials in more countries and look to “new models of oversight”, such as a quality risk management approach. The government added that the agency has agreed with all the recommendations and has “ongoing efforts or is developing new procedures to address” them.

Commenting on the HHS report, Pharmaceutical Research and Manufacturers of America senior vice president Ken Johnson said it is important to remember that “the same strict regulatory standards apply to foreign trials as trials conducted domestically. Sponsors are typically in communication with the FDA throughout clinical trials – no matter where they are conducted”.

He went on to ask: “Is it ethical to conduct such studies outside of the USA? In a word: Yes. Whether the clinical research occurs in the USA or outside its borders, our member companies must adhere to Good Clinical Practice guidelines".

Mr Johnson concluded by saying that PhRMA has conducted educational seminars and symposiums – at times, in conjunction with the FDA – in other countries to educate potential clinical trial principal investigators about GCP, “ethics oversight by outside review boards, and the need to maintain the highest standards for data quality”.