Operation Trial Blazer
This week, the US Department of Health and Human Services (HHS) announced a new initiative called ‘Operation Trial 1 Blazer’ that aims to bring back early-stage clinical research, which has increasingly been outsourced t…
Adam Kroetsch
7 blurbs citing this writer/publication
Clinical trial innovation barriers
Have you ever wondered why some innovative approaches only get used once or twice? It’s something I’ve often thought about with clinical trials. Take platform trials, which test multiple treatments within a single trial,…
FDA's real-time clinical trials pilot
One reason that clinical trials are slow, expensive, and wasteful is that the data they generate are locked in siloed systems and manually transcribed. Recently, the FDA announced a pilot project to fix this, which would…
Fixing trials means fixing the boring stuff
Adam Kroetsch has a new post arguing that if we want to make trials more efficient, we need to pay attention to the boring stuff , in other words, the unglamorous work of clinical operations like setting up trials, recru…
A whiplash week for clinical trials
It’s been a big week for clinical trials. The FDA refused to review Moderna’s flu vaccine trial despite previously indicating their trial design was acceptable. Then, they reversed course . It’s unclear what prompted the…
FDA's slow drift from two trials to one
The FDA recently announced it would shift from requiring two clinical trials to one. Why the change? In his Substack , Adam Kroetsh points out things have been moving in this direction a long time (the FDA has had the au…
How the FDA earned our trust, and why it's fraying
More Adam Kroetsh! Writing for Asterisk , he puts the FDA’s current trust woes in a longer context: how did the FDA achieve its trusted status in the first place? Kroetsch also reminds us of many of the achievements of t…