8 blurbs citing this writer/publication
This week I read what I wished I was reading last week : a detailed explanation of how Australia’s clinical trial system compares to that of the United States. The key difference is in their phase one trials, which are t…
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…
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,…
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…
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…
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…
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…
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…