Health department opens funding program to speed early-stage trials
Officials say they will back proposals that compress the time between a first human dose and proof of concept, and are weighing changes to the traditional phased system.
By Meera RaghunathanPublished · 1 min read
The Department of Health and Human Services began accepting applications Saturday for a program meant to shorten the earliest stages of clinical testing.
Grants of up to $25 million will go to teams that can show a credible plan to move from a first-in-human study to proof of concept in under eighteen months. Officials named continuous trial designs, shared control arms and remote monitoring as areas of interest.
A senior official said the department is also studying whether the three-phase structure that has governed drug testing for decades should be replaced with a single adaptive protocol for some diseases. No timeline was given.
Trade groups welcomed the funding. Patient safety advocates urged caution, noting that the first studies of any new drug are where unexpected toxicity is most likely to appear.
