China has made biotechnology a strategic national priority, systematically expanding its clinical research infrastructure with government backing, streamlined regulatory pathways, and sustained investment. In 2021, China’s global share of Phase 1 trials surpassed the United States’ share for the first time, a milestone that would have seemed unlikely just a decade earlier. And in 2024, China surpassed the United States in the total number of clinical trials registered, with over 7,100 registered, representing 39% of global trials…. For certain cutting edge modalities, including cell and gene therapy, radioligand therapy, and stem cell therapy, China uses investigator-initiated trials to provide additional flexibility, though with some tradeoffs around oversight and quality control. This means that drugs can move into human testing if a researcher has an interest and funding. In the U.S., comparable trials might wait years to start.

I am also pleased to see that they mention Australia, another advanced democracy, as a leader in clinical trial regulation:

Australia’s Clinical Trial Notification System allows trials to begin in fewer than 70 days after a final protocol is submitted, with regulatory approval granted in as little as 21 to 28 days and sites activated within 6 to 12 weeks.

Keep those comparisons in mind. Operation TrialBlazer proposes some good reforms such as CMC clarification. CMC is Chemistry, Manufacturing, and Controls–and it deals with the basics of manufacturing a drug. The FDA, however, is very risk averse and companies know that so they have often gone overboard in CMC: for example, proving stability of a formula at 6+ months when the trial is to last only a few weeks or documenting their full commercial manufacturing process before they even know if the drug works and knowing full-well that the process will be changed many times before a drug actually gets to market. In short, a lot of cost for very little benefit. The FDA is now clarifying that this kind of thing is not necessary. Good, that is low-hanging fruit. There are other good ideas as well.

But note what they are not proposing. Despite using China and Australia as exemplars they are not going down either path. Where China is fastest is in cell therapy, gene therapy, radioligand, and stem cell work and in these areas, China lets trials proceed on an investigator-initiated basis: as the TrialBlazer document puts it, a drug can move into humans “if a researcher has an interest and funding.” China then combines this open (or lax) front end (for these products) with an all-of-government industrial policy to accelerate winners.

The US is declining to go down that path. Ok, not my call, but I get it. But they are also declining to follow Australia. In Australia there is also no government prospective regulatory evaluation of most early-phase clinical trials. Under the Clinical Trial Notification (CTN) scheme, the sponsor submits their protocol package to a Human Research Ethics Committee (HRECs)–Australia’s IRBs–and once the ethics committee approves, the sponsor notifies the regulator, the Therapeutic Goods Administration (TGA), and pays a fee. The TGA does not read and clear the package before the trial starts. The roughly 21-to-28-day “approval” and sub-70-day start figures in the document are fast precisely because the regulatory step is not an evaluation. The government regulator stays out of the front end for most clinical trials, although in direct contrast with China it does step in for the highest risk biologicals. China has decided, high-risk, high-reward.

Australia does certify the certifiers, the HRECs. Europe uses a similar system for medical device approval. It’s a system proposed by former medical officer at the FDA Henry Miller and one I have long supported for the US. China is more laissez-faire.

The US architecture in contrast rests on the “gold standard” FDA reviews and the “FDA will retain full regulatory authority and decision-making.” In short, all of the TrialBlazer reforms are about making the gatekeeper faster, cheaper to prepare for, and less uncertain. None of it is about getting rid of the gatekeeper.

Addendum: Full disclosure, I did some consulting with ARPA-H on related work. See also my previous post on the a radical deregulatory approach, Montana’s SB535 and a Potential Biotech Renaissance in America

The post Two Roads to Fast Clinical Trials, and the US Takes Neither appeared first on Marginal REVOLUTION.

      

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From a very credible Labour source:

– Wes Streeting promised the Chancellorship for not running.

– Capital gains raised to match income tax. Possible exit tax.

– Economic focus: devolution, plus state ownership of cost-of-living essentials (energy, water, transport).

– Nothing on AI or tech, bar higher capital gains and an EIS/SEIS-style relief for backing British businesses. (Spoiler: startups now incorporate in Delaware and raise on SAFEs. I’ve done 60+ angel investments; only two were eligible.)

Andy and Wes don’t seem to grasp that tech has been the core engine of growth for 20 years, and AI will only accelerate that.

So why would any founder build here? How does the UK compete with the US and China on AI? Where does growth actually come from?

The world economy is changing fast, and we need to be ready to thrive in it, not just survive.

I really hope this admin appoints some figures who actually get what’s happening. Losing business support early, from a disastrous first budget, was the beginning of the end for Starmer.

So, in a nutshell, no, the UK is not improving.

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In 2014 I wrote in The New York Times that if your own team is not in the World Cup, you should root for the one whose victory would do the most good. Add up the happiness a title would create, more where more people care, more where incomes are lower, and more where a win would be a first rather than a habit, and root for the country on top. That year it was Nigeria. With 48 teams in 2026, and more of the world’s poorer and first-time sides in the field, I rebuilt the guide, with more nuance and, thanks to AI, at a fraction of the old cost. It updates itself as the games are played.

At least for now, you should root for the DRC he argues.

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Rising elderly life expectancy is a well-known source of fiscal pressure on Social Security and Medicare – but how have declining mortality and morbidity affected the two programs’ relative finances? Using nearly three decades of Medicare Current Beneficiary Survey data (1992-2019), we estimate that these demographic changes raised expected lifetime Social Security spending by over twice as much as expected lifetime Medicare spending: 14% compared to 6%. The slower growth of elderly lifetime health care spending than annuity spending reflects two features of how longevity has increased: the additional 2.4 years of remaining life expectancy were entirely healthy – free of physical or cognitive limitations – while the expected amount of time spent with severe health limitations fell by about 30%, reducing expected lifetime nursing-home and home-health use. We then write down a stylized life-cycle model of a risk-averse retiree facing stochastic mortality and health to illuminate the key forces that affect the optimal allocation of a fixed amount of public funds across Medicare and Social Security.

That is from a new NBER working paper by Liran Einav and Amy Finkelstein.  In general I wish to switch resources from Medicare to Social Security, or at least give individuals the option to do so.  You can use dollars to buy health care, but it is not always so easy to make the transformation in the opposite direction.

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The new book you can order here.

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2. “The Royal Society for Blind Children and the National Deaf Children’s Society have both come out against the Starmer social media ban.”

3. Persistently beneficial AI models.  Through general benevolence.

4. “Concerns over therapy ferrets used to kill rats at UK’s largest children’s prison.”

5. So you fly from Australia to London over the North Pole?

6. Will Burnham reverse “privatisation”?

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In 1986, Governor George Deukmejian signed Assembly Bill 3678, which required certain CPUC-regulated utilities to submit annual “plans” for buying goods and services from woman- and minority-owned companies. Two years later, CPUC created its “Supplier Diversity Program,” which would enforce the law and set contracting “goals” for large utilities.

Under a series of Democratic governors, the program has expanded to include gay-owned businesses. In September 2014, then-Governor Jerry Brown signed legislation requiring CPUC to recognize “LGBT-owned businesses” as eligible for supplier-diversity benefits. Five years later, Governor Gavin Newsom expanded the program further, “encouraging” other companies involved in the energy sector to award contracts to gay-owned firms.

…This scheme raises an obvious question: How does a business qualify as officially gay? Paperwork. Supplier Clearinghouse, a group that certifies firms for the CPUC program, features a list of qualifications linked on its website. Applicants can secure certification by providing a letter from an “LGBT organization” attesting to their sexual preferences; proof that a newspaper identified them as “LGBT”; or three letters from “personal contacts” written “on company letterhead” attesting to their homosexual orientation. Corporate officials who “falsely represent” their business as gay face up to a year in county jail.

So there you have it. Under the logic of ever increasing privileges for pretty much anyone except white males we now certify whether someone is gay or not.

This is an economics blog, however, so let’s turn from the culture war and ask, following Luke Froeb at Managerial Economics, what these set-asides cost the taxpayer:

A set-aside moves price through two separate channels, and they push the same direction.

• First, it shrinks the number of bidders, so the second-lowest cost is higher (or the second-highest value is lower).
• Second, the set-aside bidders themselves may be higher-cost or lower-value than the bidders they replace.

Both channels move price against the government….The lesson applies to California. Fewer, weaker bidders mean a worse deal for the government.

Brannman and Froeb estimate that set asides for small businesses reduce revenues in timber auctions by 15%, a substantial amount.

Addendum: It is worth noting that optimal auction theory tells us that it can sometimes be in the seller’s interest to handicap a strong bidder in order to make them increase their bids. Thus, in theory, an “affirmative action” program (not a set-aside) that deemed a bid from a minority firm as say 5% higher (so a minority bid at 100 can beat a non-minority bid at 104) could raise revenues. Note, however, that this optimal auction story only works when the minority firm loses the bid! In practice, even these sorts of schemes are money losers for the taxpayer.

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Between 2012 and 2022, the number of obese adults in Scotland rose 46 percent, to comprise about one-third of the population.

In 1950, 76 percent of Scots age 16 or older were married, now it is about 45 percent.

All those details are from the new and fun book by Alistair Moffat, To See Ourselves: A Personal History of Scotland Since 1950.  From these tidbits I conclude that “Scotland as we knew it” is not just evolving, but also disappearing.

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2. Dialogues of Confucius, translated and edited by Brian Buya and Wenwen Li.  It seems these works, once considered doubtful in provenance, are likely by Confucius after all?  So this is an epic volume of real import.  But does it raise my opinion of Confucius as a thinker?  No.

3. I liked all of Thomas F. Madden’s The Fall of Republics: A History from Ancient Carthage to the American Constitution, but most of all the section on Venice.

4. Frank Callanan, James Joyce: A Political Life.  An excellent book, and it truly induces us to revalue Joyce and understand him in a new light.  Joyce was in fact highly politically conscious, heavily influenced by Parnellism, and in part writing a critique of Irish nationalism from an internal perspective.

4. Alastair Reynolds, “Zima Blue,” one of the better short stories about AI, and also aesthetics.  Via R.

5. Justin Gest, Democratic Drain: Global Migration and the Struggle for Democracy is a political economy argument that widespread immigration can drain home countries of their democracy supporters to some extent.

Daniel Susskind, What Should My Children Do?: How to Flourish in the Age of AI is a book that needed to be written.

Melissa S. Kearney and Luke Pardue, editors.  Demographic Headwinds: The Economic Consequences of Lower Birth Rates and Longer Lives.  A short volume, to the point, worry is in order.

And there is Jeremy A. Simmons, Sea of Treasures: A Cultural History of Ancient Indian Ocean Trade.

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Here is the article, via Air Genius Gary Leff.

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2. Short TV clip of me on the Brazilian economy.

3. Patrick Collison on Paris.

4. “Thrilled to announce the inaugural cohort of the 1991 Fellowship @mercatus. Meet some of the most talented and creative minds working on challenging policy problems at the state level in India.”  Link here.

5. AI has won another literary prize.

6. Roon on worship.  Roon is one of our best thinkers.

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The Tax Cuts and Jobs Act (TCJA) of 2017 represents the most significant reform of the U.S. income tax code since the Tax Reform Act of 1986. Previous analyses of the TCJA’s economic impact often rely on estimates based on data prior to the enactment of the legislation. This paper leverages plausibly exogenous variations in state-level tax changes brought about by the TCJA and employs local projections with two-way fixed effects to examine its effects on the labor market. Measures of TCJA tax shocks are constructed with the NBER-TAXSIM model using state-level tabulations of individual income tax returns from the Statistics of Income (SOI). Our findings suggest that tax cuts amounting to 1 percent of Adjusted Gross Income (AGI) under the TCJA are associated with a 0.7–1 percentage point increase in the labor force participation rate (LFPR) and a 0.8–1.5 percent increase in payroll employment over the two years following the TCJA’s implementation. These results appear broadly robust to assumptions about heterogeneous state responses and the inclusion of interactive fixed effects.

That is from a newly published article by Anil Kumar.  Via the excellent Kevin Lewis.

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It might seem surprising, in a world of global stars, that the 6m Danes, many of whom are fluent in English, listen mainly to homegrown music. And until fairly recently they did not. In 2019 only five songs in Denmark’s top 20 were in Danish. By last year the figure was 18.

A similar trend is under way in other countries—and in other forms of entertainment. From Asia to the Americas, music charts are increasingly dominated by local sounds. Hollywood television-streaming companies are commissioning more local productions in foreign markets, causing consumption of American shows to fall. Social networks are connecting the whole world, but so far people are mainly using them to consume local content. And as video gaming expands, it too is becoming increasingly tailored to local cultures…

In 2023 Will Page and Chris Dalla Riva noted in a London School of Economics paper that a number of European countries including France, Germany, Italy and Poland had seen rising domestic shares of their top tens in the preceding decade. Since then the phenomenon seems to have spread. Mr Page, formerly chief economist at Spotify, finds that 55% of streams of songs in Sweden’s top 20 last year were in Swedish, up from 29% in 2019. Norway’s figure rose from 13% to 38% in the same period.

That is from The Economist, and of course it echoes themes from my earlier Creative Destruction: How Globalization is Changing the World’s Cultures.  And Brazil most of all?

Latin America has gone the same way (see chart 1), Brazil astonishingly so: in the first week of June 96 of the top 100 artists on YouTube Music in the country were Brazilian (foreigners included Justin Bieber and Michael Jackson). Last year Thailand had a solidly local top ten, while Indonesia and the Philippines each had eight local tracks in their respective charts; Nigeria’s top ten were all local, as were nine of South Africa’s, according to the IFPI, which represents the recorded-music industry.

The same trends are happening for television as well, albeit less radically.

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Spotify: https://open.spotify.com/episode/0HBFWS1avb6tYY1IoLefYb

Web: https://athenaeumreview.org/podcast/aesthetics-a-conversation-with-tyler-cowen/

Apple: https://podcasts.apple.com/us/podcast/aesthetics-a-conversation-with-tyler-cowen/id1509089416?i=1000773451248

Here is basic information about art scholar Benjamin Lima, it was great fun for me to do this one.

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