US FDA defends steps to monitor clinical trials

The U.S. Food and Drug Administration on 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 agency, which first announced steps in 2006 to keep up with ever-global clinical trials, said it would require special monitoring groups called institutional review boards (IRBs) to register with the government starting in September so it could better track them.

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

* FDA says it is improving trial oversight

* Congress to question trial practices on Thursday

“We wanted to make sure, since we can’t get overseas as often as we would like to conduct inspections ... that by putting this rule out there we would be establishing what we would be looking for in the marketing applications,” Joanne Less, who oversees the FDA’s Good Clinical Practice Program, said in an interview. The program helps develop standards and guidelines.

The agency’s comments come ahead of a congressional hearing on Thursday into whether the government and such review board firms are doing enough to ensure patient safety.

Drug and device manufacturers must conduct human trials for their experimental products after completing other lab and animal tests before they can win U.S. approval. As part of their studies, they hire IRB companies to monitor the process.

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

On Thursday, the 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 had no immediate comment.

For its part, the FDA said it had implemented the new requirements and was also working on voluntary guidelines for companies and IRBs to follow.

While manufacturers would not have to adhere to them, the 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 in an interview.

“We wanted to make sure that the studies (conducted outside the United States) ... would ensure the protection of human subjects and also that quality of data,” she said.

Dan Dueber, president and CEO of Coast Independent Review Board - which 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 IRB had been asked to review a clinical trial that it said was set up by the House panel using false credentials and data, it said in a statement.

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

WASHINGTON (Reuters) -