FDA Unveils Guidances on Innovative Trial Design

October 1, 2018

The FDA late last week issued two new draft guidances — one on adaptive clinical trials and the other on master protocol designs — that it hopes will help sponsors innovate and get treatments to market more swiftly and efficiently.

CTTI: New Recommendations for Decentralized Trials

October 1, 2018

Decentralized clinical trials offer a chance to expand patient pools, obtain more data and — ultimately — move medicines and treatments to market faster. But sponsors worried about risks behind the technology driving decentralization don’t have to completely abandon traditional trials, according to CTTI.

Half of EU Clinical Trial Results Not Reported

September 17, 2018

Despite EU requirements for clinical trials to report results to the EU Clinical Trials Register within a year of a trial’s completion, sponsors have only reported about half of them so far.