Features

FDA: New Approaches for Fatty Liver Clinical Trials

December 10, 2018

The FDA is encouraging fatty liver disease researchers to come up with new biomarkers for clinical trials to avoid invasive — and potentially dangerous — biopsies that drive away many would-be participants.

New Training Standards Sought for PIs

December 3, 2018

Two influential clinical industry groups are focusing on new training efforts to prevent principal investigators from burning out and it appears that the FDA is willing to work with them on the effort.

FDA Wants to Modernize 510(k) Trials

December 3, 2018

The FDA says it wants to modernize device clinical trials by using more up-to-date technologies as comparators to make sure only the safest, most effective devices get to market.

FDA Trials Inspection Algorithm: Be Ready

November 19, 2018

The clinical trials industry is just coming to grips with a new FDA approach to inspections that uses advanced computer algorithms to flag trials for risk.

Are Clinical Trials Headed for Tech Disruption?

November 5, 2018

Stanford University researchers last week announced they had enrolled 400,000 patients in a clinical trial to test whether an app on the new Apple Watch can effectively screen for a heart-rhythm disorder.