It doesn’t take two trials
In June, the FDA issued new draft guidance stating that drug makers no longer needed to run two trials to demonstrate the efficacy of a new drug before it could be approved; rather, “one adequate and well-controlled clin…
Clinical Trials
27 blurbs
Ask your bookie if this drug is right for you
Kalshi, one of the biggest prediction market platforms, announced last week that it has started letting people bet on the outcomes of clinical trials and FDA regulatory decisions. This would make it possible for investor…
Advanced market clinical trial design commitments
I enjoyed reading a post by Witold Więcek on the Clinical Trials Abundance blog, titled ‘ Market shaping and trial design belong together ’. He explains why people interested in solving market shaping problems – such as …
Anthropic develops drugs
Anthropic made two announcements in the last week about its plans in AI for science. First was the launch of Claude Science , a platform that integrates dozens of scientific databases and bioinformatics models and curren…
Operation Trial Blazer
This week, the US Department of Health and Human Services (HHS) announced a new initiative called ‘Operation Trial 1 Blazer’ that aims to bring back early-stage clinical research, which has increasingly been outsourced t…
You should read Dario Amodei’s latest essay
If you’re staying on top of AI news, you probably don’t need me to tell you to read Anthropic CEO Dario Amodei’s latest essay . That said … you should read Dario Amodei’s latest essay. It’s the most detailed look at the …
Clinical trial innovation barriers
Have you ever wondered why some innovative approaches only get used once or twice? It’s something I’ve often thought about with clinical trials. Take platform trials, which test multiple treatments within a single trial,…
Cancer breakthroughs at ASCO
We’re experimenting with a different format where we occasionally spotlight a slightly longer What we’re reading post. Our regular roundup from earlier this week is posted here . Dr. Brian Wolpin, who presented the resul…
Joe Lonsdale’s FDA reform agenda
Joe Lonsdale’s recent Substack post, “What America Needs from a New FDA Commissioner,” is notable as much for who’s saying it as for what it says. Lonsdale is a Palantir cofounder turned venture capitalist who is closely…
Pooling drug reviews across Africa
What is it like to know that a new drug exists – and has been proven safe and effective – but that it simply isn’t available where you live, and you might die without it? This was the reality for millions of Africans dur…
Makary's downfall at the FDA
FDA Commissioner Marty Makary resigned this week, just over a year in the role. It seemed sudden from the outside, but was reportedly a long time coming internally, with months of friction with RFK Jr. Apparently, the fi…
FDA's real-time clinical trials pilot
One reason that clinical trials are slow, expensive, and wasteful is that the data they generate are locked in siloed systems and manually transcribed. Recently, the FDA announced a pilot project to fix this, which would…
What pandemic trials got right
Saloni Dattani: I don’t have a foundational text that drew me to clinical trial reform. I learnt about the topic during the Covid-19 pandemic. It was surprising how efficient some pandemic clinical trials were and, despi…
A podcast wishlist for clinical trial reform
On a new episode of the Works in Progress podcast, Ruxandra Teslo, Ben Southwood and I chatted about everything you wanted to know about clinical trial reform — from why ethics reviews are so inefficient to how Australia…
Can AI reverse Eroom's Law?
Eroom’s Law (the reverse of “Moore’s Law”), for those of us who don’t spend all our days thinking about pharmaceutical innovation, is a term describing the historical trend that the R&D cost of developing a new drug seem…
A Lyme disease vaccine, maybe, finally
We might finally get a vaccine against Lyme disease ! Maybe. Hopefully? Unfortunately, the confidence intervals in the phase three trial were really wide: after four doses, its efficacy was estimated at 73.2%, with a 95%…
What faster drug approvals are worth
I’ve been revisiting some older papers that might shed light on the benefits of faster clinical trials. Let’s start with a short 2007 paper by Frank Lichtenberg, which looked at the correlations between deaths from vario…
Fixing trials means fixing the boring stuff
Adam Kroetsch has a new post arguing that if we want to make trials more efficient, we need to pay attention to the boring stuff , in other words, the unglamorous work of clinical operations like setting up trials, recru…
A whiplash week for clinical trials
It’s been a big week for clinical trials. The FDA refused to review Moderna’s flu vaccine trial despite previously indicating their trial design was acceptable. Then, they reversed course . It’s unclear what prompted the…
NIH stops calling EEG studies clinical trials
It’s admin burden week in the AGF Innovation Policy vertical. Let’s start with the good: last week the NIH announced that they will no longer consider “Basic Experimental Studies Involving Humans (BESH)” to be clinical t…
Fixing IRBs without shortchanging research subjects
Institutional Review Boards (IRBs) are meant to protect research participants, but today their fragmented standards often create needless delays. In a new piece for the Institute for Progress, Ruxandra Teslo argues that …
A public option for off-patent drug trials
When drugs lose patent protection, the incentive for large-scale clinical trials of new indications dries up. A recent working paper estimates that hundreds of new uses for existing drugs have gone undeveloped as a resul…
Bayesian trials, with frequentist training wheels
The Food and Drug Administration has released a draft “Guidance for Industry” on using Bayesian methodology in clinical trials for drugs and biologics, which has been in the works for several years. It lays out practical…
FDA's slow drift from two trials to one
The FDA recently announced it would shift from requiring two clinical trials to one. Why the change? In his Substack , Adam Kroetsh points out things have been moving in this direction a long time (the FDA has had the au…
In search of better surrogate endpoints
One reason clinical trials can take a long time is because it can take a long time to see how a patient’s condition turns out - some diseases have a slow progression. A good “surrogate endpoint” is a biomarker that relia…
How the FDA earned our trust, and why it's fraying
More Adam Kroetsh! Writing for Asterisk , he puts the FDA’s current trust woes in a longer context: how did the FDA achieve its trusted status in the first place? Kroetsch also reminds us of many of the achievements of t…
A tour of 2025's medical breakthroughs
As an aside, if we needed a reminder about why scientific progress and clinical trial speed matters, Abundance and Growth Fund team member Saloni Dattani gives us a tour of medical breakthroughs of 2025 on her substack.