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It feels like this is a good way to solve Woodcock and other problems found in the drug trial pipeline.In fact, Woodcock’s FDA released a series of new Guidelines Used to create more of these master protocol trials.
However, none of these can solve the same pressing problem: time. In any of these studies, it is difficult to find Covid patients to participate. The nature of the pandemic is that it will have peaks and valleys at different times and places in the world. Currently, our largest recruiter is in India, which will not surprise you,” said Gordon of Remap-Cap. “Now, their research capabilities are not as good as those in the United Kingdom and the United States, so even though their caseload is higher, they The number of recruits is far less than the number we recruited in the UK. “
The vaccine will never completely eliminate Covid-19. In countries/regions where it is available, some people refuse to take it; some countries cannot afford it. Therefore, good Covid drugs are still very important. But even so, these tests are still a bit late. “The concept is great. Researcher David Boulware, an infectious disease physician at the University of Minnesota School of Medicine who participated in Activ-6 and some other Covid trials, said: “The concept a year ago will be better. “He said, don’t blame science for the delay, but politics.
Woodcock served in the FDA last year and worked in treatment as part of the Trump administration’s “Operation Warp Speed”. The plan helped to produce vaccines that are now circulating, but the urgency of treatment is less urgent. “Obviously, the previous government had no real interest in research, because all of this will disappear before last Easter,” Bourwell said, adjusting to the then President Trump Unfounded optimism At the beginning of the pandemic. “So, all of this happened after January 20, 2021.”
No matter what obstacles are to politics, so is money. (As Carl Zimmer write in New York TimesAs of January last year, the U.S. government has spent about 18 billion U.S. dollars on vaccine research and development and about 8 billion U.S. dollars on treatment.One of the early successes in finding Covid drugs is Redesivir, A shiny antiviral drug produced by the pharmaceutical company Gilead; the United States Learn The survey conducted with the help of the company’s help and materials in April 2020 reduced the time for people to develop symptoms; Learn include help each other Found no impact on survival.
But generic drugs cannot make pharmaceutical companies the same revenue, so they won’t get the same corporate push. Research on cheap, reused drugs usually requires government funding. “Many of these are generic drugs. So why not push it forward? Because there are no patents, there is no profit motive for pharmaceutical companies. No pharmaceutical company says,’We will give you $10 million to solve this problem,'” Boulware said. “So the government must do this, and the government must do the same. The good news is that these are all drugs sold in low- and middle-income countries or Walgreens. This does not mean that “we invented some There are no new drugs, but six months from now, we will have enough drugs to treat 10,000 people, and each dose will cost US$10,000. “”
This gave rise to another, more ambitious insight, which Woodcock hoped would prevent the chaos of small trials in the area. Next Pandemic-a more economical and effective master plan for testing more than one drug at a time. Woodcock said: “If you look at the results of all treatments, especially immunomodulators, the interesting thing about this pandemic is that there is still a lot of backtracking about which treatment should be used. Our test results are contradictory,” Woodcock said. . “It usually means that the therapeutic effect is small, and the trials are not enough to give a clear answer.” Large, multi-arm, master agreement studies are designed to bridge the gap between large pharmaceutical companies conducting large, expensive trials on large, expensive drugs. There is no gap between small, trait tests that produce enough new knowledge. During the pandemic, there is not enough government-funded, ambitious, middle ground research-flaws in the system cause casualties.
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