March 4th, 2011 by admin

US Government calls for stricter regulation of foreign clinical trials

A troubled US Department of Health and Human Services issued a report in 2010 highlighting their concern about a lack of monitoring and inspections of foreign clinical trials carried out by the Food and Drug Administration.

According to the report between 40%-65% of clinical trials investigating FDA-regulated products are now done outside the USA, mostly to reduce costs.

The American government now worries about those clinical trials done in developing countries. According to the report there is not much certainty about the ability of local regulatory bodies and institutional review boards to adequately monitor trials; protect subjects’ rights and ensure that data integrity is not compromised.

The US Department of Health and Human Services is also worried that results obtained from a clinical trial in a developing country might not be “completely applicable to the US population.”

Their report analysed data from 2008 when 80% of approved drugs and biologics contained data from foreign clinical trials. According to the report, the FDA inspected 1.9% of domestic trial sites but only 0.7% of foreign sites.

The HHS has recommended that the FDA must require standardised electronic clinical trial data and also create an internal database. They also want the FDA to monitor trends in foreign clinical trials not conducted under Investigational New Drug Applications “and, if necessary, take steps to encourage sponsors to file INDs,” according to their statement.

The US government also wants the FDA to conclude agreements with foreign regulatory bodies that will allow for trials to be inspected and risk management.

The FDA has agreed to implement these recommendations and address the concerns highlighted in the report.

In a separate statement the senior vice president of Pharmaceutical Research and Manufacturers of America, Ken Johnson said it was important to remember that “the same strict regulatory standards apply to foreign trials as trials conducted domestically … Whether the clinical research occurs in the USA or outside its borders, our member companies must adhere to Good Clinical Practice guidelines.”

He said they made sure that foreign regulatory bodies are up to speed with “ethics oversight by outside review boards, and the need to maintain the highest standards for data quality.”

The Association of Clinical Research Organisations in turn said they were supportive of the US government’s efforts to ensure better oversight in clinical trials conducted in developing countries but said it should not stop the globalisation of clinical trials.

“We promote efforts to strengthen the globalisation of the clinical research enterprise in order to speed the development of life-saving medicines and treatments for patients who need them.”

ACRO pointed out that according to a study done in July last year, the time it takes to develop a new, and possibly life saving drug, can be reduced by half by globalising trials.