Trial initiatives to protect patients, integrity of data

Share this article:
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.

Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M Future Leaders

Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...