New post!
It may seem ambitious to ask for individual patient data from clinical trials to be shared, anonymized, for use by other researchers.
But the history of medicine shows us that clinical trials have already undergone a series of transformations that once seemed equally bold:
I think this leaves a gap for most people, that many feel cannot be filled in the secular world.
And to be fair, I think this doesn't just apply to very unsuccessful people. There's no good answer for how we should regard ourselves when we're weak.
I don't think equality as a human right is lame.
But the insistence on a certain type of equality and oppression in various movements is clearly born out of the fact that equality can't really be realized in practice when it comes to outcomes.
My new essay on why the modern world is so preoccupied with equality and oppression.
In a secular age, they often function as a form of consolation. When transcendence recedes, the "non-winners" lose the dignity once grounded in a divine, cosmic order.
www.writingruxandrabio.com/p/equality-a...
Amazingly thought provoking from @ruxandrabio.bsky.social : substack.com/home/post/p-...
Abundance, but for research? New drugs are taking a long time to reach the market, in part because of how long clinical trials take. @ruxandrabio.bsky.social explains Australia's model, which makes early clinical trials easier and how it's leading everyone to move their trials there.
More broadly, the key regulatory question has shifted: instead of βhow do we filter out the junk scienceβ β a goal well-supported by frequentist methods β FDA and drug companies are trying to use scarce clinical data as efficiently as possible to make informed determinations about each drug that crosses its desk. Thatβs where Bayesian statistics shines. The choice FDA now faces is not whether or not to rely on prior evidence; itβs whether to do so awkwardly, in its current frequentist framework β in which that borrowing is implicit and unstructured; or using the more structured approach offered by Bayesian statistics. The publication of this guidance suggests that FDA is starting to embrace the more structured approach.
The FDA recently published guidance on Bayesian statistics in clinical trials.
If there's one thing you read about it, let it be this great post by Adam Kroetsch:
www.clinicaltrialsabundance.blog/p/will-bayes...
Welcome to the Clinical Trials Abundance blog! This is a joint blog where weβll post ideas, thoughts and commentary about clinical trials and how to make them more efficient. Clinical trials are how new drugs are tested before becoming widely available. In most countries, like the US and UK, where we live, trials are expensive and slow. Effective drugs can be stuck in clinical trials for years, sometimes a decade or more, before the results are clear and those drugs are available to patients who need them. Clinical trials are also generally treated as a high-stakes, one-shot test to produce a final binary decision on whether a drug works, rather than as part of an ongoing evidence loop that could help accelerate innovation.
NEW BLOG!
Ruxandra Teslo @ruxandrabio.bsky.social, Adam Kroetsch, Manjari Narayan @neurostats.org, Witold WiΔcek and I have started a joint blog on clinical trial reform.
We'll aim to publish weekly on how to make clinical trials more efficient.
Subscribe: clinicaltrialsabundance.blog
This is a really good post. Itβs worth reading even if youβre not a health research geek. I find it incredibly useful when someone gives me a sense of how stuff works in a field I am not familiar with, at least not on a suitably granular level, and this post does that.
Adding to the confusion, entrepreneur Dr. Jing Liang noted on X that publicly available trial data appear to show Moderna conducted analyses involving higher-dose comparators in older adults. If accurate, it would raise further questions about the basis for issuing a refusal-to-file letter in the first place. No matter which account ultimately proves correct, this episode leaves us with two uncomfortable possibilities. If the FDA changed its regulatory position after years of clinical development, that reinforces a persistent concern about regulatory inconsistency. If, alternatively, Moderna met the agencyβs highest level of stated expectations, actually did use a high-dose comparator and still received a refusal-to-file letter, the implications are even more serious, raising questions about transparency and internal coherence at the agency.
Great post @ruxandrabio.bsky.social on FDAβs refusal to review Modernaβs flu vaccine, changing its position on what trial design was acceptable.
Regulatory uncertainty doesnβt just mean missing out on this vaccine, but also reduces future R&D investment:
clinicaltrialsabundance.blog/p/the-modern...
In 2023, papers denying motherhoodβs role in the gender wage gap went viral. I called out their flawed assumptions then, and newer results have proven me right.
www.writingruxandrabio.com/p/of-course-...
Plus remote or hybrid work.
Itβs a game changer for us mums who also work outside the home.
Sure there are many jobs that are needlessly exploitative or employers who demand long hrs for little salary etc etc. but, leaving that aside, being a good scientist will always involve a ton of work in ur early years of training
Or take my job as a scientist: I need to spend long hrs to train myself and read papers and so on. I don't see how that can change. It's intrinsic to the job.
I don't see how you can change the fact that for example in order to run a business it takes very long hours and is very demanding. Or that certain surgeries take 12 hrs to complete and in that time you need to be on call.
The next frontier is conquering the motherhood penalty, which has the dual effect of holding women back in their professional lives and stopping them from having the families they'd like to have, through technological advances like in vitro gametogenesis or improved egg freezing
Menopause is pretty unique to us.
What accounts for our relative lack of knowledge when it comes to female reproductive aging?
One reason is the uniqueness of the human female reproductive system, which it makes it harder to study in animal models. Menstruation occurs only in humans and a few primates!
And it's perfectly fine for women to opt into such jobs and not aim to be CEOs or whatever. But some do want to, and the reality is is that it conflicts with also spending loads of time caring for little kids
In fact Claudia goldin talks about the pharmacist career which isn't a greedy career, pays well, and is quite flexible and the gender gap is quite small. That's because of the nature of the job. You don't need to be on call at odd hrs etc
Employment conditions are not shitty. There are plenty of jobs where you can work part time or which are family friendly. But if you wanna be a CEO you'll obvsly have to work more than 40 hrs per week
Women who experience menopause earlier in life or due to surgical removal of their ovaries face even higher risks for these chronic conditions, suggesting that functioning ovaries have a health-protective effect, and later menopause correlates with increased longevity.
Delaying egg aging might postpone the onset of menopause. As a womanβs eggs are depleted, the ovaries send out fewer chemical signals, and she goes through menopause. Menopause is associated w/ age-related diseases such as dementia, cardiovascular disease, and osteoporosis.
Also, making egg freezing less painful and easier or making eggs from stem cells isn't exactly changing women' bodies
Another solution is simply to delay the aging of the oocytes!
Unfortunately, this solution lies at the intersection of two fields that have traditionally not shown great success. We do not have any approved aging drug and women's health's approvals are the smallest %!
But the higher risks of IVG also come with higher rewards. If companies like Conception are successful, we will be able to completely side-step the egg collection and freezing process!
In-vitro gametogenesis (IVG) is riskier than IVM. With maturation, stem cells form ovarian support cells that help eggs mature but are discarded afterward, so mistakes arenβt passed on. In IVG, however, eggs are made from stem cells, meaning any errors can affect the baby.
Women can opt to not work or reduce hours at the moment. I'm not taking away that option from them
Researchers are pushing boundaries by using proteins (transcription factors) to steer egg development in culture. In 2024, a Harvard team achieved the first induction of human meiosis in vitro, marking a significant leap.
Below progression of stages of meiosis over time
Why?
