I led a lot of data and analytics work for pharma companies on clinic trials and the point about complexity is hard to overestimate. A pretty good analogy for bringing a major new drug to market is comparing it to building a new space flight system, individually it might have one less zero on total cost, but that's more of a factor of humans bringing dozens of drugs to market at any one point so there are economies of scale rather than it being any less complex.
Also, the article does a good job of describing one side of clinical trial complexity, finding participants and getting them through the funnel, but there's a whole other source of complexity in clinical trials that mean you need massive global efforts: different global regulators have different criteria for 'approving' clinical trials. An indicative example, the Japanese regulator needs to see evidence that the drug was tested in Japan during a trial. They're one of _many_ national regulators that say that.
So even if you _could_ find all a trials participants in one country you likely wouldn't be able to get it approved by many national regulators.
There are 100% valid epidemiological reasons, but often these differing national rules are there for policy purposes outside of drug safety, for example, if you mandate trials need to take place in your country it provides a nice investment in biotech for your economy or by creating specific rules as a lever to control cost in your national healthcare system (e.g. NICE in the UK).
At least in the US, the article discusses a valid but frustratingly incomplete step per-nation.
There's a broken incentive system for doctors: they are in small/regional academic centers and get rewarded for recruiting, but mostly when there are few other participating doctors (and thus limiting # hospitals & included communities). You don't get the pharma relationship/funding, no academic recognition for being one middle author over many, no time for understanding all the trials, etc. For blockbuster trials like COVID, the care ROI potential is obvious, but few are like that.
Stuff like cancer is a pathologically bad case bc you often do need that wider net, even when going for an ultimately small patient group. You don't know which hospitals people with the markers being targeted will show up at, nor if they'll fill your diversity goals (... which pharma doesn't actually want as part of the negotiated trial setup, another story). But even if a national register identifies a regional patient + their care provider, chances are, that's not enough for the doctor to enroll the patient.
National registers, or at least more smoothly federated ones, are a good step to decreasing some of the patient identification cost. For cancer, with growing regional genome databases, especially so. But there are several big carrots + sticks doctors face when choosing which trials the system wants them to pursue, and the COVID stuff was able to skip much of that.
Source: daily dinner conv with someone doing the treatment/prescribing, trial enrollment, and working on one of the US's biggest national registers, including to use data to solve targeted trials, yet still struggling.
Many drugs work differently for different genetic pre-conditions. Making sure that a drug works for the majority of your population is a valid goal.
The current climate (due to the pandemic) is to throw many regulations over board. However, many of them have been paid for in blood. And finally pharma companies can't be trusted. Not at the slightest.
If researchers could test a new cancer treatment, instead of just hoping that the right patients turn up on the right day, they could instantly let everyone with that cancer know that they could join a trial.
This already kind of happens - it’s why clinical trials are done in academic centers by research-focused physicians. They know roughly how many patients they have and are happy to try and recruit them.
No doubt there are more efficiencies to be driven out of trials, but when you need to monitor patients for 12+ months, regularly screen them and run tests, that’s just not going to be cheap or quick.
I was going to ask that question... just about every person I've known with a serious cancer has had an opportunity to get an unapproved treatment (whether that was a trial, or off-label, or something else, I don't know). I know people who did one or other of the COVID vaccine trials.
It seems researchers are absolutely not sitting around hoping that the right patient turns up.
The article advocates conducting trials in a single country, to massively simplify the complexity. I understand the attraction, but doesn't that lead to drugs that work fine for that population, but not for others (less effective and/or more side effects)? If I recall correctly I have recently read articles that some drugs are already too specific to one population, and not enough information is available about best treatment options for other populations.
I imagine doing trials in a single country only increases the risk of that happening.
Companies would also quickly find the cheapest country to do trials in - and we can only wonder what would make it cheaper to run trials in one country vs. another. Less infrastructure, less government red tape, fewer regulations? Someplace far from watchful eyes?
Fiction, obviously, but there was a John Le Carre novel where a evil drug company did secret trials in an African country because it was easier to cover up the deaths of participants.
"The Constant Gardener". I haven't read the book but I've seen the 2005 movie adaptation. I didn't know (or perhaps had already forgotten) that he movie is based on a John Le Carré novel.
Apologies for what is basically off-topic hijacking, but I've been a reader of the Economist since ~2005, when I was a uni student the first time. I've got pretty diverse political views, but neither Dems nor Republicans would claim me as their own, nor indeed would anarchists, fascists, or just about anybody else. I suppose I'd be classified as an independent, but the point is just that over the past 2-3 years the Economist has basically become unreadable for me, not necessarily because I find their political views increasingly obnoxious (which I do), but because it seems like their views have become simplistic to the point of being naive - their recent pieces on Putin and Ukraine being Exhibit A in this regard. Didn't The Economist used to have deep, or at the very least DEEPER analysis than they now offer? Just wondering if anybody else feels the same way and has found anything else that works for them. The closest thing for me has been Foreign Affairs, but of course along with very deep analysis on foreign policy is the fact that oftentimes one is reading a very biased opinion from a career civil servant (notwithstanding that the articles are invariably well written and well argued). One might even argue that knowing the writer is biased makes for more interesting reading because you're constantly questioning their claims; reading the Economist, as the saying used to go, was like hearing declarative statements from God. The Financial Times and WSJ are both too 'shallow' and financially focussed for what I'm talking about - if I just want headlines and news synopses then any of the NYT, the WSJ, and WashPo will do, but I'm talking about consistently in-depth discussions and analysis of current issues.
I have been a subscriber for the past 20 years. Before I go further, I would argue my consumption model has changed even more than The Economist has changed. My consumption model has changed because the sources of deep and specialist coverage have increased. FWIW, I still find The Economist immerse-worthy, and I do enjoy it a lot. I have, however, increased my signal sources by subscribing to Financial Times, The Information, etc.
I like the long form articles produced 1843, a sister brand of The Economist.
All said and done, you and I probably are getting older, more cynical and The Economist is one in a long list of casualties :).
Agreed about 1843, but it seems rare that they've got a proper longform article these days - or maybe they do but none of them are interesting to me.
Speaking of longform, I use Longform.org almost daily and just noticed that they're shutting down, or at least they're no longer aggregating articles. Wonder what happened.
I used to read the Economist and likewise gave it up in 2021 due to the creeping politicisation and simplification of their coverage. I think this is representative of a larger illness that is pervading Western journalism, an ideological illness that has journalists viewing themselves as school marms of the hoi polloi rather than reporters and analysts of fact.
My suggestion is to peruse smart political magazines from a diversity of sources. Four I can recommend for this purpose are
https://jacobinmag.com ("democratic socialist" a la Sanders. Critical of the Democrats from the left. Frequently critiques establishment policies on numerous issues, occasionally including foreign policy.)
https://www.tabletmag.com (Jewish conservative magazine. A useful balance to my other selections in that it is Zionist.)
https://www.theamericanconservative.com (This magazine is one of the few smart conservative publications. It is critical of Republican interventionist foreign policy and free trade ideology. It is very culturally conservative.)
https://unherd.com (This British magazine doesn't have a specific orientation. It leans slightly cultural conservative, but doesn't have a big bias on other issues in my view, and even on cultural topics it publishes feminist viewpoints.)
And then, since these magazines are all fairly contra-establishment, you can wash down their flaming hot takes with a nice glass of neoliberal apologetics, by simply visiting any other newspaper of magazine, and viewing either the headlines or the opinion section--they are pretty much indistinguishable at this point anyway.
Thanks for these. Tablet and Unherd both seem interesting, though perhaps a bit more 'bloglike' and less journalistic than I'd prefer - even The American Conservative had an interesting, albeit short, article about white farmers. Obviously quite partisan though. Your tactic seems to be to collect a diverse array of opinions, whereas I'm a bit more closed minded - I'd rather find an outlet I agree with on most things, or least whose reasoning I agree with and follow, and then just stick to them.
Thing is, even their science quarterlies have badly missed the mark recently. I remember a few years ago they had some in-depth articles on biology about genes and evolution and the explanations were both unnecessarily difficult and in some cases outright wrong, both of which are the opposite of what the Economist is known for.
