U. of Minn. Accused of Serious Human Research Errors

Consumer advocacy watchdog Public Citizen is calling for an in-depth investigation of alleged human subject protection violations at the University of Minnesota between 2011 and 2014 and revocation of the university’s human subjects research credentials. Read More

MHRA Releases Trial Approval Statistics

The UK’s Medicines and Healthcare products Regulatory Authority approved approximately one-quarter of Phase I and one-third of Phase II-IV clinical trials on first review between April 2014 and March of 2015. Read More

JAMA Study Recommends Better Research Publication

The FDA should make unredacted results of clinical trial site inspections more readily available to the public and to readers and editors of scientific journals, to ensure transparency about tainted studies and potentially bogus drugs, an article in the February JAMA Internal Medicine says. Read More

EMA Defends Redacting Humira Trial Reports

The European Medicines Agency is defending its decision to redact certain clinical study reports for AbbVie’s Humira before releasing them to a researcher, setting up a test case for the EU’s new trial transparency policy. Read More

German Watchdog Calls EMA’s Definition of CCI too Broad

A German regulator says European Medicines Agency plans for implementing its clinical trials database let drugmakers withhold too much information, such as study protocols, methods and trial results, under the exemption for commercially confidential information. Read More