Another problem has been the kind of internecine push-and-pull between hospitals and individual researchers. They are all frenemies, all pursuing the goal of helping people, but are also published in major magazines in pursuit of officials and subsidies. That’s not necessarily bad – if the energy is directed. “The study with lowest lift that you can do as a clinic scientist is to write down the cases that come through your center. It’s not that hard to do, and it’s an empty elevator. But if you want to make an impact, you have to overcome it, ”says Turakhia. “We need to move away from academic opportunism, only that you have a paper, and figure out how you can come together and work together.”
That opportunism is not just ambition. It risks actually disrespecting (if not directly 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 highlight striving for all of us. Our patients volunteer, in most cases, to be part of these studies, and data and their bodies contribute to help advance our knowledge. There’s a cost to doing research, ” said Wang, who wrote a comment next to it JAMA internal medicine article. “Would it not be possible, especially in this age of communication and technology, to be more efficient early on?”
Gellad takes an even harder line. “Every small group did its own experiment instead of an organized, central effort to say, ‘These are the most important central efforts. These are the threads we are going to do, ” he says.
Debt the system, if you will. Large therapeutic subjects are expensive, so only pharmaceutical companies and governments tend to have the bank accounts to withdraw them. A whole host of potential funders, from the NIH to the Gates Foundation and on and on, are pulling researchers in many directions. A lack of central patient data means that even if hospital systems and researchers want to collaborate, it is difficult for them to talk to each other digitally. The mechanisms for protecting patients’ rights and keeping them safe during research trials are widespread and independent; not one suggests eliminating the institutional assessment boards at individual hospitals and research centers, but a large study protocol might have to deal with dozens of them, each with veto power. And finally, as reporter Susan Dominus points out in a recent article The New York Times Magazine, hospitals and clinicians may feel that their duty to patients means that they should try everything and everything to save their lives, instead of enrolling in studies that may randomize them into the control group (even though the study may ultimately save more lives ).
These problems have always challenged drug investigations and the people who mount them. As with so many system failures, the pandemic has only exacerbated the problem. “There is no doubt that we do not lack an organized and systematic approach to testing therapeutic ideas,” said 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 any other weaknesses that lead to partial results and lack of generalizability are apparently bad, “but I do not know to say something other than that is always the case, really. “
Exposing these problems can provide the stimulus and ideas to fix them. Turakhia thinks a solution – perhaps for the next pandemic – would be a whole network of centers ready to create clinical trials at some point. Just fill in the keywords on the paperwork. ‘We need a lot of sites that are a priori ready to go. ‘We have signed up, the IRBs have a fast-track mechanism,’ ‘he says. “You just have to have the right infrastructure and the purchasing and dedication to the vision. The operational aspects, the approvals, and all that – you can get it all figured out. ‘
It’s the kind of system that could actually make the world a better place if someone built it. “We all agree that it is imperative to do this, and time is of the essence,” Wang says. “Now we just have to make the machine that runs this a little faster. And I’m sure this machine will continue to exist after the pandemic. The shift of spinners for spinning wheels after synchronization will not be an easy lift, but it is clearly a necessity.
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