Covid-19 Drug Research Is a Big Huge Mess

Another problem has been the kind of internecine push-and-pull among hospitals and individual researchers. They’re all frenemies, all chasing the goal of helping people, but also getting published in big journals in pursuit of tenure and grants. That’s not necessarily bad—if the energy gets directed. “The lowest-lift study you can do as a clinician scientist is to write up the cases that come through your center. It’s not that hard to do, and it’s a low lift. But if you want impact, you’ve got to get over that,” Turakhia says. “We have to get away from academic opportunism, just so you have a paper, and figure out how to get together and work collaboratively.”

That opportunism isn’t just ambition. It actually risks disrespecting (if not outright harming) patients. “When we do clinical research, it isn’t just a researcher saying, ‘Here’s a good idea, let’s go do it.’ Research is a high-stakes endeavor for all of us. Our patients are volunteering, in most cases, to be parts of these studies, contributing data and their bodies to help us advance knowledge. There’s a cost to doing research,” says Wang, who wrote a commentary that ran alongside the JAMA Internal Medicine article. “Wouldn’t it seem possible, especially in this age of communication and technology, to be more efficient early on?”

Gellad takes an even harder line. “Every little group was doing its own trial rather than having an organized, central effort to say, ‘These are the most important central efforts. These are the trials we’re going to do,’” he says.

Blame the system, if you want. Big therapeutic trials are expensive, so only pharmaceutical companies and governments tend to have the bank accounts to pull them off. A whole grab bag of potential funders, from the NIH to the Gates Foundation and on and on, pulls researchers in many directions. A lack of central patient data means that even when hospital systems and researchers want to collaborate, it’s hard for them to talk to each other, digitally speaking. The mechanisms for protecting patients’ rights and keeping them safe during research trials are scattered and independent; no one is suggesting eliminating the institutional review boards at individual hospitals and research centers, but a big study protocol might have to deal with dozens of them, each one with veto power. And in the end, as the reporter Susan Dominus shows in a recent article in The New York Times Magazine, hospitalists and clinicians might feel that their duty to patients means they should try anything and everything to save their lives, rather than enroll them in studies that might randomize them to the control group (even though the study might eventually save more lives overall).

These problems have always challenged drug trials and the people who mount them. As with so many system failures, the pandemic has only made the issue worse. “There is no doubt we lack any sort of organized and systematic approach to testing therapeutic ideas,” says Peter Bach, director of the Center for Health Policy and Outcomes and the Drug Pricing Lab at Memorial Sloan Kettering Cancer Center. Bach says that small trials that risk false positive results, studies that use squishy outcomes instead of mortality, and all the other weaknesses that lead to biased results and lack of generalizability are obviously bad, “but I don’t know what to say other than it is always like this, really.”

Exposing these problems might provide the incentive and ideas to fix them. Turakhia thinks a solution—maybe for the next pandemic—would be a whole network of centers ready to mount clinical trials at a moment’s notice. Just fill in the nouns on the paperwork. “We need a bunch of sites that are a priori ready to go. ‘We’ve signed off, the IRBs have a fast-track mechanism,’” he says. “You just need the right infrastructure and the buy-in and commitment to the vision. The operational aspects, the approvals, and all that—you can get all that up and running.”

It’s the kind of system that could actually make the world better, if someone builds it. “All of us agree there is an imperative to do this, and time is of the essence,” Wang says. “Now we just need to make the machine that makes this run a little faster. And I’m certain this machine will persist after the pandemic.” The shift from spinning wheels to gears turning in sync won’t be an easy lift, but it’s clearly a necessary one.

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