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 reversal (likely political backlash), but as Ruxandra Teslo argues in a new blog post, the episode highlights how regulatory uncertainty can be worse than strict standards, making it harder to plan for and meet standards. On a more positive note, Adam Kroetsch laid out thoughts on the FDA’s new Bayesian statistics guidance that I found particularly helpful. He explains that the new guidance has been a long time coming and should help translate subjective judgment into a more transparent, quantitative framework. He also argues that it is especially valuable as the FDA has shifted from screening large numbers of low-quality trials and requiring two statistically significant trials per drug, to evaluating fewer, larger trials that can incorporate additional sources of evidence.