We can make clinical research better for everyone!
Joined June 2011
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185 Photos and videos
8 Nov 2025
James Watson was a bad guy and carried himself terribly, especially around female peers, and that’s how he should be remembered.
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8 Nov 2025
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…
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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
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AdamJButler retweeted
9 Feb 2024
Instead of an election let’s just see who can draw a clock better
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19 Sep 2023
Today I learned that “Versorgungsrealität” is the German word for standard of care.
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21 Feb 2023
“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…
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21 Feb 2023
The draft guidance on external controls is really interesting. IP issues on secondary data usage in pharma are already complicated. RWE market is now a fight for as much analyzable data as possible.
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18 Nov 2022
Amy Abernathy at @CNSSummit “we need to make sure these technologies work for site coordinators.” Coordinators are the true workhorses of clinical trials!
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13 Oct 2022
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…
17 Sep 2022
Reviewing a pitch from a health tech startup. Under “Science & Outcomes” are three “lorem ipsum” bullets 🧐
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8 Aug 2022
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-…
2 Aug 2022
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…
18 Jul 2022
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…
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18 Jul 2022
(This paper is from 1991, and some subsequent RCTs showed that it probably didn't work.) pubmed.ncbi.nlm.nih.gov/1705…
13 Jun 2022
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…
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28 May 2022
What a blockbuster from @bddol - FDA leadership overrode an internal review to grant Apple’s Afib device a de novo
exitsandoutcomes.com/who-con…
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19 May 2022
Having Janet Woodcock take responsibility for the Office of Digital Transformation will be a huge win for adoption of new technology in trials
19 May 2022
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-…
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13 May 2022
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…
6 Apr 2022
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…
29 Mar 2022
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…
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29 Mar 2022
Footnote says "These are theoretical examples. The authors do not assert that hand tapping would be a measure of hand function/dexterity without appropriate evaluation of the analytical and clinical evidence." It seems confusing to include this example.