Covid-19 drug research is a huge mess
Another problem has been the type of internal back and forth between hospitals and individual researchers. They are all enemies, all with the goal of helping people, but also published in major journals seeking warrants and grants. It doesn’t have to be bad, if the energy is directed. “The weakest study you can do as a clinician scientist is to write up the cases that go through your center. It’s not that hard to do, and it’s a low lift. But if you want an impact, you have to overcome it, ”says Turakhia. “We need to move away from academic opportunism, just so you have an article and figure out how to come together and work together.”
This opportunism is not just an ambition. In fact, it risks disrespecting (or even harming) patients. “When we do clinical research, it’s not just a researcher who says, ‘Here’s a good idea, let’s go. Research is a business with high stakes for all of us. Our patients volunteer, in most cases, to be a part of these studies, providing data and their bodies to help us advance knowledge. Research comes at a cost, ”says Wang, who wrote a commentary alongside JAMA Internal Medicine article. “Doesn’t it seem possible, especially in the age of communication and technology, to be more efficient from the start?”
Gellad takes an even harder line. “Each small group did its own try rather than having an organized, central effort to say, ‘These are the most important central efforts. These are the tests that we are going to do, ”he said.
Blame the system, if you want to. Large drug trials are expensive, so only drug companies and governments tend to have the bank accounts to withdraw them. A host of potential funders, from the NIH to the Gates Foundation and so on, are attracting researchers in many directions. The lack of central patient data means that even when hospital systems and researchers want to collaborate, it is difficult for them to speak to each other, digitally. The mechanisms for protecting patients’ rights and their safety during research trials are dispersed and independent; no one is suggesting eliminating institutional review boards from individual hospitals and research centers, but a large study protocol might have to deal with dozens of them, each with veto power. And in the end, like journalist Susan Dominus shows in a recent article in The New York Times Magazine, hospitalists and clinicians may think that their duty to patients means that they should try anything and everything to save their lives, rather than enrolling them in studies that might randomize them to the control group (although the study could potentially save more lives overall).
These issues have always challenged drug trials and the people who set them up. As with many system failures, the pandemic has only made the problem worse. “There is no doubt that we lack an 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 spongy results 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 except it’s always like that, really.
Exposing these problems could provide an incentive and ideas for solving them. Turakhia believes that a solution – perhaps for the next pandemic – would be a whole network of centers ready to mount clinical trials at any time. Just fill in the names on the paperwork. “We need a bunch of sites that are basically ready to go. “We signed, the IRBs have a fast track mechanism,” he said. “You just need the right infrastructure, buy-in and commitment to the vision. The operational aspects, approvals and all that – you can do it all. “
It’s the kind of system that could really make the world a better place, if you build it. “We all agree that it is imperative to do this, and time is running out,” Wang said. “Now we just have to make the machine that makes it a little faster. And I’m sure this machine will persist after the pandemic. Changing from spinning wheels to synchronously spinning gears won’t be an easy task, but it is clearly a necessity.
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