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Covid-19 drug research is a big mess



Another problem has been the type of internal push for hospitals and individual researchers. They are all frenzy, all pursuing the goal of helping people, but also being published in major magazines in pursuit of mandate and grants. This is not necessarily a bad thing – if the energy is directed. “The study of the lowest elevation you can do as a clinical scientist is to design the cases that come to your center. It is not that difficult to do, and it is a low elevation. But if you want impact, you have to overcome it, “We need to move away from academic opportunism, just so you have a letter, and understand how to come together and work collaboratively,”

; says Turakhia.

This opportunism is not just ambition. It actually risks disrespecting (if not completely harming) patients. “When we do clinical research, it ‘s not just a researcher who says,’ Here ‘s a good idea, let’ s do it. “Research is a high effort for all of us. Our patients volunteer, in most cases, to be part of these studies, contributing data and their bodies to help us advance knowledge. ‘It’s a cost to do research, “says Wang, who wrote a comment that went alongside 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 small group was making its own trial rather than making an organized, central effort to say, ‘These are the most important central efforts.’ “These are the judgments we will make,” he said.

Blame the system, if you will. Large therapeutic exams are expensive, so only pharmaceutical companies and governments tend to have bank accounts to withdraw them. A whole bag of potential funds, from the NIH to the Gates Foundation and beyond, attracts researchers in many directions. The lack of data on central patients means that even when hospital systems and researchers want to collaborate, it is difficult for them to talk to each other, speaking digitally. Mechanisms for protecting patients’ rights and safeguarding them during investigative trials are distributed and independent; No one is suggesting the elimination of institutional review boards in individual hospitals and research centers, but a large study protocol may have to deal with dozens of them, each with veto power. And finally, as reporter Susan Dominus points out in a recent article in New York Times Magazine, hospitalists and clinicians may think that their duty to patients means that they should try everything and everything to save their lives, rather than enroll them in studies that may randomize them to control group (although the study may eventually save more lives overall).

These problems have always challenged drug trials and the people who assemble them. As with so many system failures, the pandemic has only made matters worse. “There is no doubt that we lack any kind of organized and systematic approach to testing therapeutic ideas,” says Peter Bach, director of the Center for Health Policy and Outcomes and the Drug Imaging Laboratory at the Sloan Kettering Center of the Cancer Center. Bach says small judgments that jeopardize false-positive results, studies that use clear-cut results instead of mortality, and all the other weaknesses that lead to biased results and lack of generalizability are obviously bad, “but I do not know what to say other than is always so, “

Exposing these problems can provide incentives and ideas to solve them. Turakhia thinks a solution – perhaps for the next pandemic – would be a whole network of centers ready to set up clinical trials at some point in the announcement. Just fill in the names on the paperwork. “We need a bunch of sites that are a priori ready to go.” We signed, the IRBs have a fast mechanism, “he says. “You just need the right infrastructure and the acquisition and commitment to the vision. “Operational aspects, approvals and everything you can get everything that works.”

It’s the kind of system that can actually make the world a better place if one builds it. “We all agree that there is an imperative to do this, and time is of the essence,” Wang says. Now we need to make the car that makes this work a little faster. And I’m sure this car will continue after the pandemic. “Switching from rotating wheels to synchronous gears will not be an easy lift, but it is clearly a must.


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