Advocating for challenge trial volunteers, who get diseases to help test new vaccines and enable other critical medical advances.
Joined April 2020
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Can data from health records and insurance claims make medical research faster, cheaper, and more informative?
Join us Monday, Nov 9 at 10:30 AM ET for a live expert panel on real-world evidence in clinical research and regulatory decision-making.
Our panelists will discuss how real world evidence is used today, explain where that use falls short, and discusss the policy changes that could expand its role.
Watch online and bring your questions for the live Q&A. Register here: us02web.zoom.us/webinar/regi…
@joshcmorrison argues that the FDA’s on-again, off-again release of complete response letters is often framed as transparency vs. trade secrets. But the bigger question may be whether FDA can redact CRLs fast and consistently enough to keep publishing them at all.
In @ClinicalLeader1 @joshcmorrison makes the case that the FDA should define what an “appropriately redacted” CRL is, then use AI for first-pass redactions with human review. Capacity may decide whether real-time release survives: clinicalleader.com/doc/an-in…
Trials We Love!
What’s happening?
NIH’s NIAID is recruiting healthy adults ages 18–50 for a dengue human challenge study, in which volunteers receive a weakened dengue virus so researchers can see how the body responds.
The impact: There are still no treatments for dengue, a mosquito-borne virus that can cause shock, internal bleeding, and death, so understanding how it behaves in the body is a key step toward new therapies.
Learn more: clinicalstudies.info.nih.gov…
At 1Day Sooner, we believe volunteers are essential to medical progress.
Learn more about volunteering at the NIH Clinical Center: www2.cc.nih.gov/hvsignup/
Sign up to hear about trials in your area: 1daysooner.org/volunteer/
The bipartisan Faster Clinical Trials Act from @RepAuchincloss and @RepMGriffith promises to make U.S. clinical research faster and more accessible.
We’re gathering organizational signatures on an open letter of support: docs.google.com/forms/d/e/1F…
FDA clarity: clearer guidance on what can be redacted when FDA discloses Complete Response Letters means less guesswork and less avoidable friction in drug development.
With PDUFA reauthorization approaching, Congress can build on this moment. Sign the letter here: docs.google.com/forms/d/e/1F… and learn more about the Clinical Trial Abundance agenda here: 1daysooner.org/clinical-tria…
1Day Sooner supports the "Faster Clinical Trials Act," which you can read more about here: cnbc.com/2026/10/22/bipartis…
The 🧵 below explains what we hope this bill can accomplish!
It started with a tweet: a Zika challenge study nearby needed healthy volunteers. Keller Scholl signed up, was deliberately infected at Johns Hopkins, and later wrote about the experience for @WorksInProgMag
His essay is a candid look inside a challenge trial: the consent process, the debate over paying volunteers, and why carefully controlled infections can generate better data while sparing far more people than studying outbreaks in the wild.
Keller now serves on our Participant Council, making sure volunteers have a voice in how trials are designed.
Learn more about Keller here: 1daysooner.org/meet-keller-s…
And read this @WorksInProgMag piece here: worksinprogress.co/issue/lif…
