Note: The Skinny blog is written by Rick Smith, editor and co-founder of Local Tech Wire and business editor of

RESEARCH TRIANGLE PARK, N.C. – This Associated Press headline ought to grab the attention of every life science executive in the Triangle:

“Report: FDA struggles to track foreign drug trials.”

Added The AP: “FDA officials said they agreed with the inspector general’s recommendations, according to the report.”

Here’s how the report phrased the FDA reaction:

“FDA agreed with all three of our recommendations. It also stated that it has ongoing efforts or is developing new procedures to address each recommendation.”

The RTP region is home to one of the nation’s largest life science/biotech industry clusters. So the bet here is that this new report from the Inspector General for the Department of Health and Human Services is going to be mandatory reading for management and staff today.

The Triangle area is rapidly growing into a hub for contract research organizations and life sciences services firms that conduct clinical trials for pharmaceutical and biotech firms around the world. From Quintiles – the largest CRO based in Durham/RTP – to Pharmaceutical Product Development to a host of others, the report is raising red flags.

Not only do many of these firms operate internationally, but they also rely more and more on clinical trials outside the U.S. Their clients include big drug makers, including many (GlaxoSmithKline, Merck, etc.) that have major operations here.

Note this paragraph:

“Sponsors may realize benefits from conducting research abroad, such as lower costs in some countries or the ability to conduct larger trials in less time. Despite the benefits to the sponsors, critics have raised concerns about the increased prevalence of foreign clinical trials, particularly those conducted in developing countries. The concerns cited by medical ethicists include the ability of local regulatory bodies and institutional review boards to adequately monitor clinical trials to protect thje rights and welfare of subjects and to ensure data integrity. Other critics question the extent to which the results of foreign clinical trials conducted in developing countries are generalizable to the U.S. population.”

Here are some highlights from the report:

“In FY 2008, sponsors relied heavily on data from foreign clinical trials to support their marketing applications for drugs and biologics … Of 80 percent of approved marketing applications for drugs and biologics contained data from foreign clinical trials; over 50 percent clinical trial subjects and sites outside US sponsors’ reliance on foreign clinical trials … appears likely to grow.”

“FDA inspected clinical investigations at less than 1 percent of foreign sites.” [Note: 0.7 percent of foreign sites vs. 1.9 percent domestic sites.]

“Challenges to conducting foreign inspections and data limitations inhibit FDA’s ability to monitor foreign clinical trials.”

Recommendations from the report are:

“FDA should require standardized electronic clinical trial data and create an internal database

“FDA should monitor trends in foreign clinical trials not conducted under INDs and, if necessary, take steps to encourage sponsors to file INDs.

“FDA should continue to explore ways to expand its oversight of foreign clinical trials.

1. Continue to develop inspectional agreements with foreign regulatory bodies
2. Inspect clinical trials in more countries
3. Look to new models of oversight”

The AP noted that a number of groups question the increasing reliance on foreign trials, including Dr. Sidney Wolfe at Public Citizen, a consumer advocacy group:.

"The quality of the data used by the FDA as a basis for approving the drugs being studied may well be flawed, resulting in dangerous, incorrect decisions to approve drugs.”

for the complete report. It’s sobering, to say the least.

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