AdamJButler

Amy Abernathy at @CNSSummit “we need to make sure these technologies work for site coordinators.” Coordinators are the true workhorses of clinical trials!

There are only 13 active recruitment sites in the US for patients who had COVID more than one month ago, all of them are giant academic centers.

What a blockbuster from @bddol - FDA leadership overrode an internal review to grant Apple’s Afib device a de novo exitsandoutcomes.com/who-con…

When the FDA COA office rejected Verily's VME, they specified finger-tapping as not meaningful. In this paper just published by FDA CDRH, they use finger-tapping as an example of a possible digital biomarker. nature.com/articles/s41746-0…

Really interesting paper from Verily on a fully remote observational study of patients with depression. One important finding - incentive payments to increase engagement only worked on healthy controls! mental.jmir.org/2021/8/e2758…

In 2020, planned enrollment in Alzheimer's trials was already at an all-time high. When Biogen rolls out a post-marketing study requiring thousands more trial participants, study enrichment will be stretched to the breaking point.

The 6MWT is not a great endpoint and these study results for a rare disease population are really good. The FDA should definitely approve this! endpts.com/rare-disease-drug…

I have learned that one really good way to keep up with new “digital biomarkers” is to click on every Instagram ad - my stories are full of stuff like this

This is a very interesting analysis!

This is total patient enrollment by year for all industry-funded Phase 2 and 3 Alzheimer's Disease intervention trials since 2011. There has been a huge surge in demand for patients to enroll in these trials. Aduhelm impact on US trial recruitment will be huge!