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:

Email Newsletters

More in News

BI rethinks hepatitis business, posts 2013 results

BI rethinks hepatitis business, posts 2013 results

Boehringer Ingelheim says it is no longer pursuing an interferon-free combination of faldaprevir and deleobuvir.

Roche wraps quarter with two fewer pipeline medications

Roche wraps quarter with two fewer pipeline medications

Roche also announced first-quarter sales shrank 1%.

2013 favored specialists, specialty Rx

2013 favored specialists, specialty Rx

The latest IMS Institute for Healthcare Informatics assessment of 2013's prescription drug use shows that 2.3% of prescriptions account for 30% of a patient's out-of-pocket prescription costs.