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Covid-19 drug research is a big mess



Another problem was the nature of internecine push-and-pull in hospitals and individual researchers. They are all frenemies, all aiming to help people but are also published in major magazines for tenure and scholarships. That’s not necessarily a bad thing – when the energy is conducted. “The lowest stroke study you can do as a clinical scientist is to write down the cases that come through your center. It’s not that hard to do, and it’s a low elevator. But if you want to make an impact, you have to get over it, ”says Turakhia. “We need to break away from academic opportunism just so you can have a paper and figure out how to come together and work together.”

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This opportunism is not just ambition. Indeed, there is a risk that patients will be disregarded (if not directly harmed). “When we’re doing clinical research, it’s not just a researcher who says, ‘This is a good idea, let’s do it.’ Research is important to all of us. Our patients, for the most part, volunteer as part of these studies and add data and their bodies to further knowledge. Research comes at a cost, “said Wang, who made a comment wrote who ran alongside JAMA internal medicine Items. “Wouldn’t it be possible to be more efficient early on, especially in times of communication and technology?”

Gellad takes an even tougher line. “Each small group had its own process instead of making an organized, centralized effort to say, ‘These are the most important centralized efforts. These are the experiments we are going to make, ”he says.

Blame the system if you will. Large therapeutic trials are expensive, so only drug companies and governments have the bank accounts to withdraw them. Quite a number of potential funders, from the NIH to the Gates Foundation and so on, are drawing researchers in many directions. The lack of central patient data means that even when hospital systems and researchers want to work together, it is difficult for them to talk to one another digitally. The mechanisms for protecting patient rights and their safety during research studies are dispersed and independent. Nobody is proposing to remove the institutional review bodies in individual hospitals and research centers, but a large study protocol may have to deal with dozens of them, each with veto power. And in the end, as reporter Susan Dominus shows in a recent article in The New York Times MagazineHospital doctors and clinicians may feel that their duty to patients means that they should try everything to save their lives, rather than enrolling them in studies that might happen to place them in the control group (although the study ultimately saved more lives overall could).

These problems have always called drug trials and the people who conduct them into question. As with so many system outages, the pandemic has only made the problem worse. “There is no doubt that we lack an organized and systematic approach to testing therapeutic ideas,” said Peter Bach, director of the Center for Health Policies and Results and the Drug Pricing Lab at Memorial Sloan Kettering Cancer Center. Bach says that small studies that risk false positives, studies that use squishy results instead of mortality, and all the other weaknesses that lead to biased results and a lack of generalizability are obviously bad, “but I don’t know what I am should say differently than it really always is. “

Exposing these issues could provide the incentive and ideas to fix them. Turakhia believes that one solution – perhaps for the next pandemic – would be a whole network of centers ready to conduct clinical trials shortly. Just fill in the nouns on the paper. “We need a number of websites that are ready to go a priori. “We 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 permits, and all of that – you can make it all work. “

It’s the kind of system that could actually make the world better if someone built it. “We all agree that this is imperative and time is of the essence,” said Wang. “Now all we have to do is manufacture the machine that will run a little faster. And I am sure that this machine will persist after the pandemic. “Switching from spinning wheels to synchronously shifting gears is no easy lifting, but it is clearly necessary.


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