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…
On a new episode of the Works in Progress podcast, Ruxandra Teslo, Ben Southwood and I chatted about everything you wanted to know about clinical trial reform — from why ethics reviews are so inefficient to how Australia…
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…
Institutional Review Boards (IRBs) are meant to protect research participants, but today their fragmented standards often create needless delays. In a new piece for the Institute for Progress, Ruxandra Teslo argues that …
One reason clinical trials can take a long time is because it can take a long time to see how a patient’s condition turns out - some diseases have a slow progression. A good “surrogate endpoint” is a biomarker that relia…