I hosted Meri Beckwith, CEO of Lindus Health, on my podcast Development & Research. Meri founded Lindus after being a clinical trial patient—because he was astounded at how badly clinical drug trials were being run by the world's leading companies.

We talk about why clinical trials companies are twenty years behind in adopting new technologies, how a flooded supply closet can cause a billion-dollar clinical trial to fail, and his speculation about the incentives that—so far—have stopped the world from getting better.

Links: { Twitter, YouTube, full transcript, Spotify, EA Forum }

Here's a section I particularly enjoyed:

Meri Beckwith: Yep. We do active patient recruitment for most of the trials we run—and recruitment is a really important, often overlooked, aspect of trials.

If you talk to any executive in pharma and ask, "What's your biggest pain point for clinical trials?" they'll probably say, "Patient recruitment." And then, if you ask them, "What can I give you to solve this pain point?" they'll probably say, "More clinical trial sites."

Look, your average clinical trial might have 500 patients; you typically see 300 clinical sites. These are 300 physical locations, each of which often has a cupboard of physical documents that need to be created and signed—that might get flooded, per my example earlier—

Ross: —for two patients per site?

Meri Beckwith: For their two patients, yeah. It's violently inefficient, but that is how most trials are set up.

Ross: And that means that the site administrators are doing it for the first time—for all 500 patients?

Meri Beckwith: Right. That’s key, and one of the most absurd parts of this setup is, not only is it violently inefficient cost-wise, it makes the data manifestly worse. Firstly, it’s just hard to keep track of all that data, but secondly—you have a team of nurses and investigators at each site who interpret the protocol slightly differently, adding massive variance to what should be a clean experiment.

Ross: It’s wild to think that this can even be considered a 'controlled' trial. Like, I have these treatment patients and these placebo patients, and every one of them was at a different hospital. I feel like the treatment and placebo should have been at the same hospital and gotten the same—

Meri Beckwith: —yeah, and that is a really absurd state of affairs... (continues)

Meri Beckwith: For another example, you can look at the FDA's guidance on things like risk-based monitoring [Ross: discussed elsewhere 1, 2], central monitoring, and decentralized trials. These are all techniques that leverage technology and allow you to run trials at significantly lower cost—

Ross: —by changing how you collect data?

Meri Beckwith: Yes, a "decentralized" trial would have some or all of the trial happen remotely, so a patient never visits a physical site. Fully-remote trials are only possible for a subset of trials, but we think a lot of trials could benefit [from some remote elements].

Like—in my vaccine Phase III, we had to come into the hospital once a week or once a month just to fill out some paper forms. And this was during COVID.

Ross: Just for the papers?

Meri Beckwith: No physical exam—just filling out paper forms with a pen. And I was like, “Why?”

I actually thought, at one point, maybe this is a stealth human challenge trial [Ross: meaning, a trial where vaccinated patients are exposed to an infectious source under very controlled conditions.]—I'm in this windowless room, there's no ventilation, and there's 10 of us filling out these paper forms...

I asked these investigators, “Hey, you don't want me here—why aren’t we just getting this to you online?” and they said, “Oh—I don't know. I mean, we were just told to give you these paper forms.”

Ross: —and these are the site leads?

Meri Beckwith: These are the doctors at the site, so they aren't the CRO or the sponsor. They just do what they're told. "Only following orders"... But a decentralized trial would have us doing that remotely, on an app or a web form.

I think the key thing here is that it's not all-or-nothing, and we think often the most efficient study design is you have your dosing, your medical exams in person, but you have follow-up visits remotely. Patients massively prefer it, because who wants to take a day out to go to a hospital for filling out forms? It's obviously a lot cheaper because you're not paying the hospital costs—

Ross: Yeah, I think that's the thing that boggles my mind when I start to think about it.

It's not only were you there and you had to be a patient who was sufficiently committed to the cause to go there weekly to fill out the forms—you've then got the investigator and the research nurse and the hospital staff and the room in the hospital where you all had to be. Delivery of healthcare in the US and the UK is not cheap, and those things, I can't imagine, were cheap to the bottom line of the trial.

Meri Beckwith: Yeah, exactly. So decentralizing is one technique you can use to remove these bottlenecks. The FDA is very supportive of it.

Pharma are very skeptical of it—for basically no good reason, just inertia...

The FDA guidance document says, “We are very disappointed that the industry does not adopt these approaches,” which is crazy that you have the regulator admonishing the industry for not adopting technology and not doing things that are better economically. And I think that gets to the heart of something very strange going on with pharma incentives... (continues)