Trial initiatives to protect patients, integrity of data

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The FDA has announced policy and regulatory initiatives intended to strengthen its oversight and protection of patients in clinical trials and the integrity of clinical trial data used to make regulatory decisions.

The agency's deputy commissioner for operations Janet Woodcock said the sweeping new approaches are necessitated by an evolution in clinical trials which have become increasingly large, decentralized, and global.

She said the FDA plans to propose regulations to counter the reluctance of some research-sponsoring companies to report “people with criminal intent” who are seeing patients and changing some of their data: The sponsors fear that if they report, the study will be jeopardized.

“This is very, very terrible,” Woodcock said, because it allows criminals to proliferate in clinical research.

Woodcock suggested most of the problem seems to be in overseas studies (see right), and stressed that companies would not be penalized for reporting criminal behavior. However, she did not say what will happen to the affected studies.

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