Slumdog Clinical Trials - now the FDA steps in (with a little help from Congress)

The Food and Drug Administration Wednesday defended its ongoing efforts to improve clinical trial oversight and protect patients at a time when a growing number of companies are studying new drugs and devices outside the United States.

The FDA, which first announced actions in 2006 to keep up with global clinical trials, said it would require monitoring groups called institutional review boards to register with the government starting in September to better track the trials.

It also said that it issued new standards for data collected from certain studies conducted in other countries by drug and device manufacturers.

"We wanted to make sure that the studies... would ensure the protection of human subjects and also that quality of data," Joanne Less, who oversees the FDA's Good Clinical Practice Program, said in an interview. The program helps develop standards and guidelines.

A congressional hearing is due to be held on Thursday into whether the United States and such review board firms, or IRBs, are doing enough to ensure patient safety.

Before they can win U.S. approval, drug and device manufacturers must conduct human trials for experimental products after completing lab and animal tests. They hire IRB companies to monitor the process.

Some lawmakers are concerned that the review process is not regulated enough, and they have raised questions about IRBs' oversight, since such companies are hired by manufacturers doing the research.

On Thursday, a House Energy and Commerce panel will hear from FDA's Less and others on the issue and release a report from congressional investigators. A representative for the panel declined to comment.

The FDA said it had implemented new requirements and was working on voluntary guidelines for companies and IRBs to follow. While manufacturers do not have to adhere to them, guidelines could help them collect strong enough data to submit a product to the FDA for approval as well as to keep patients safe, Less said.

The FDA detailed its efforts in a report released on its website here. In the report, the FDA said its actions included shifting more resources to inspect ongoing studies.

Still, while FDA bears "the ultimate responsibility," companies, scientific investigators, and review boards must also ensure patients are kept as safe as possible, Less said.

"Everyone has a role, and everyone needs to perform because if they don't (human) subjects could be put at risk. The idea behind the system is that it's a system of checks and balances... it's not just one person's responsibility," she said.

The sting!

The head of one review board that earlier this month said it had been the target of what it called a "sting" operation by congressional investigators is also expected to testify.

Coast Independent Review Board had been asked to review a clinical trial that it earlier said was set up by the House panel using false credentials and data. Representatives for President and CEO Dan Dueber declined to comment Wednesday.

Its clients include AstraZeneca Plc, Eli Lilly and Co, GlaxoSmithKline Plc and Pfizer Inc, among others, according to the company's website.

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