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In June, the FDA issued new draft guidance stating that drug makers no longer needed to run two trials to demonstrate the efficacy of a new drug before it could be approved; rather, “one adequate and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…
Saloni Dattani
26 blurbs
The Two McNamaras
I enjoyed reading Oliver Kim’s article on the two lives of Robert McNamara: one as US secretary of defense and chief escalator of the Vietnam War, the other as World Bank president and crusader against global poverty. He…
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 …
Designing a cancer vaccine
The great blogger known as owlposting has an awesome new podcast episode with Alex Rubinsteyn and Ben Vincent, two scientists who work on cancer immunotherapy, on ‘How to design a cancer vaccine’. The general idea behind…
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…
Oops, I ordered the wrong antibody again
Meme from the Internet The science sleuth Sholto David recently uncovered a mix up that’s affected hundreds of papers in biology. Scientists who were intending to work with the p16-INK4a antibody, to flag a tumor suppres…
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…
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…
Biotech's financial engineering tricks
Drug development fails 95% of the time, making biotech a brutal investment environment. So how does the industry keep the money flowing? Abhishaike Mahajan, also known as Owl Posting, has a great post on the financial en…
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…
Catching up on biotech news you missed
Separately, Niko McCarty and I wrote a round-up of news you might have missed in biotech and medicine . For example, did you know that organ donations have become vastly more efficient because of improvements in preservi…
What cash transfers taught us about foreign aid
My friend Lauren Gilbert has launched a new magazine called In Development , aiming to be the New Yorker (or Works in Progress?) for global development. I enjoyed reading the inaugural piece by Paul Niehaus, co-founder o…
A bounty for cheaper biology experiments
Niko McCarty, founder of Asimov Press and now a fellow at Astera Institute, recently ran a bounty to surface new ideas to reduce the cost of lab experiments in biology. I found his reflections really interesting. He rece…
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%…
Farewell to the best biology magazine
The very best biology magazine in the world, Asimov Press , announced they’re winding down (for now). I’ve been an advisor to them since before they started, and I’m very sad to hear the news, even though I’m looking for…
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…
BioNTech's founders plan their third startup
I’ve also been following the BioNTech announcement that co-founders Ugur Sahin and Özlem Türeci will leave the company by year-end to start a new biotech focused on next-generation mRNA therapeutics (their third startup)…
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…
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 …
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…