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by Joe8Bit
1572 days ago
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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). |
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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.