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Who Owns the FDA's Thinking?
A law firm says that FDA’s rejection letters reveal too much. That may be exactly why the public needs them.
Published on Policy and Practice
•
Jun 1
May 2026
FDA’s Real-Time Clinical Trials Pilot Could Transform Drug Development
The approach is promising. The challenge is scaling it up.
May 11
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Adam Kroetsch
25
6
6
April 2026
How to speed up clinical trials
Why is drug testing so slow and inefficient, and how can we fix it?
Published on The Works in Progress Newsletter
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Apr 22
56:13
Clinical Trials Were Not Always This Complicated
How trials got so bureaucratic, and how some leaders pushed back
Apr 8
•
Adam Kroetsch
42
4
11
March 2026
FDA Bayesian trials guidance is good, but will we make a good use of it?
How can regulators apply their own guidance?
Mar 30
•
Witold Więcek
17
7
Perhaps you, too, could work on Clinical Trial Abundance!
1Day Sooner are hiring a policy lead for their new Clinical Trial Abundance program.
Mar 13
•
Saloni Dattani
9
5
To fix trials, we need to pay attention to the boring stuff
Trial operations are getting less productive and more expensive. That needs to change.
Mar 9
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Adam Kroetsch
21
2
4
Clinical trial reforms that once seemed radical
How randomized controlled trials, preregistration, and results reporting became standard practice.
Mar 4
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Saloni Dattani
31
13
February 2026
AI won't automatically accelerate clinical trials
A response to Dario Amodei.
Feb 28
•
Ruxandra Teslo
19
4
2
Learning from Australia: towards a "Clinic-in-the-loop" future
The Australian framework for early-stage trials has been around for 30 years and shows speed and safety do not have to come at each other's expense
Feb 18
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Ruxandra Teslo
20
4
8
Will Bayesian Statistics Transform Trials?
FDA has finally published its Bayesian guidance. Will it matter?
Feb 16
•
Adam Kroetsch
29
5
7
The FDA should not change its mind last minute
In which Ruxandra explains why the consequences of the FDA's RTF to Moderna extend far beyond the current vaccine program
Feb 11
•
Ruxandra Teslo
28
5
9
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