Monday, September 26, 2016

New Federal Rules Target Woeful Reporting of Clinical Trial Results


SEPTEMBER 16, 2016

WASHINGTON — Researchers will have to publicly report the results of many more clinical trials, including some for drugs and devices that never reach the market, under new government rules announced Friday.

The federal rules, which also require more complete reporting of deaths, clarify and strengthen a 2007 law that requires researchers to report results of many human studies of experimental treatments for ailments such as diabetes, cancer, and heart disease.

A STAT investigation last year found widespread noncompliance with reporting requirements by both drug companies and academic institutions — including universities that are among the top recipients of government research funding, and by National Institutes of Health staff scientists. In the vast majority of cases, study results were reported long after statutory deadlines or not at all.

Yet not a single researcher or trial sponsor has been fined or penalized, STAT reported — though the Food and Drug Administration had the authority to fine violators more than an aggregate $25 billion since the law went into force in 2008.

Continue reading

Thank You Mr Pillar and Stat News

color us, . . . . snooze.

With all the damage shrinks do to consumers day in and day out, . . . and can't connect the dots, . . . 

Does anyone believe this is more than just more butt covering?

Garbage In Equals Garbage Out, Systematic Reviews And Meta Analysis Can Tell Us A Flawed Story.

No comments: