We can make clinical research better for everyone!
Philadelphia, PA, USA
Joined June 2011
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James Watson was a bad guy and carried himself terribly, especially around female peers, and that’s how he should be remembered.
Also a racist who went to the grave believing that Charles Murray’s race science was real. The late Sharon Begley’s obituary tells the story quite well. statnews.com/2025/11/07/jame…
AdamJButler retweeted
Join academic, industry, and regulatory global leaders at the ISCTM/ECNP Joint Autumn Conference to address challenges and future directions in CNS trials! Amsterdam, Netherlands 9-11 October isctmautumn.societyconferenc…
#ISCTM #ECNP #CNS #trials #methodology
“If sponsors do not own the data used for the external control arm, they should structure their agreements with the data owners to ensure that patient-level data can be provided to FDA in support of the marketing application.”
fda.gov/media/164960/downloa…
Amy Abernathy at @CNSSummit “we need to make sure these technologies work for site coordinators.” Coordinators are the true workhorses of clinical trials!
Placebo response is a methodology problem: “Paradoxical results were observed in certain study sites, where placebo dramatically outperformed REL-1017. Relmada is investigating the nature of these results.” relmada.com/investors/news/p…
Reviewing a pitch from a health tech startup. Under “Science & Outcomes” are three “lorem ipsum” bullets 🧐
Karuna answers the question “can you rehabilitate a failed drug by designing better studies?” with a definitive yes. Managing placebo response in this population is hard, and this data shows clear signals of improvement. investors.karunatx.com/news-…
This is a huge issue - I’m certain the attrition rates on lots of app-based treatments are high. But it’s also important to consider that adherence to pharmacological treatment for patients with psych conditions is around 50%. statnews.com/2022/08/02/pear…
A new automated system for measuring nocturnal scratch! "The piezo film is essentially a contact microphone on the fingernail of the scratching subject. The method is currently incorporated into clinical trials, and preliminary results are promising." pubmed.ncbi.nlm.nih.gov/1933…
(This paper is from 1991, and some subsequent RCTs showed that it probably didn't work.) pubmed.ncbi.nlm.nih.gov/1705…
Rune Labs news is really interesting. I wonder - are they collecting raw data from the Apple Watch and analyzing it for tremors, or simply reporting the Apple data through Health Kit? statnews.com/2022/06/13/appl…
What a blockbuster from @bddol - FDA leadership overrode an internal review to grant Apple’s Afib device a de novo
exitsandoutcomes.com/who-con…
Having Janet Woodcock take responsibility for the Office of Digital Transformation will be a huge win for adoption of new technology in trials
FDA commissioner Rob Califf told staff that longtime drug center director Janet Woodcock, who’s serving as his principal deputy, would take on more of a role as “a strategic thought partner, with decision-making authorities” at several offices within FDA.
endpts.com/fda-commissioner-…
A glut of new digital tools with no evidence and no plans for evidence are not helping anyone. FDA enforcement of approval standards can’t happen soon enough for all of these CBT apps with no data statnews.com/2022/05/12/ment…
Repeated sickle cell failures feels similar to neuro and psych failures - no great or consistent biomarkers, noisy primary outcome measures, low effect sizes. Huge opportunity to introduce meaningful digital measures.
globenewswire.com/news-relea…
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…
