It feels like this is a good way to deal with the various problems that Woodcock and others found in the drug testing pipeline.In fact, Woodcock’s FDA released a huge set of new Guidelines Used to create more of these master protocol trials.
But none of these can solve an equally pressing problem: time. In any of these studies, it is difficult to find Covid patients to recruit. “The essence of the pandemic is that it will have peaks and valleys at different times and places in the world. Now, our largest recruiter is in India, and you won’t be surprised,” said Gordon of Remap-Cap. “Right now, they are not as prepared for research as the UK and the US, so their number of recruits is far less than the number we recruited in the UK, even though their caseload is higher.”
The vaccine will never completely eliminate Covid-19. In countries/regions where they can be used, some people refuse to take them; some countries cannot afford them. So good Covid drugs are still very important. But even so, these trials feel a bit late. “The concept is great. The concept a year ago will be better,” said David Boulware, an infectious disease doctor and researcher at the University of Minnesota School of Medicine who participated in Activ-6 and some other Covid trials. He said, don’t blame the delay on science, but on politics.
Woodcock worked at the FDA last year and worked on treatment as part of the Trump administration’s “Operation Distorted Speed.” The plan helped produce a vaccine that can now defeat the pandemic, but the urgency of treatment is less…urgent. “It is clear that the previous administration was not really interested in the research, because all of this will disappear before Easter last year,” Boulware said, adjusting then-President Trump’s Unfounded optimism At the beginning of the epidemic. “So all this happened after January 20, 2021.”
Where there are political obstacles, there are financial obstacles. (As Carl Zimmer wrote in New York TimesAs of January last year, the U.S. government has spent approximately US$18 billion on vaccine research and development and approximately US$8 billion on treatment. ) However, as always, pharmaceutical funding has played a big role in clearing the way for drugs.One of the early successes in finding Covid drugs was Remdesivir, A shiny antiviral drug produced by Gilead Pharmaceuticals; United States Learn In April 2020, conducted with the assistance and materials of the company, it was found that it reduced the length of time that people had symptoms; Learn include Unity Found no impact on survival.
But generic drugs won’t make pharmaceutical companies the same money, so they won’t get the same company’s push. Research on cheap, reused drugs usually requires government funding. “Many of them are generic drugs. So why are these not being promoted? Because there are no patents, pharmaceutical companies have no profit motive. No pharmaceutical company says,’We will give you $10 million to research this,'” Boulware said. “So the government has to do this, the government has to want to do it. The good news is that these drugs are available in low- and middle-income countries, or on Walgreens Street. This is not’we invented some new drugs that we don’t actually have. , But in six months we will have enough medicine to treat 10,000 people, and each dose will cost US$10,000.’”
This led to another, more ambitious insight that Woodcock hopes to prevent chaos in small trials Next Pandemic-a more economical and effective master protocol for testing more than one drug at the same time. “The interesting thing about this pandemic is that if you look at all the results of the treatment, especially the results of immunomodulators, you will find that there is still a lot of debate about which regimen should be used, and our trial results are conflicting. “Woodcock said. “This usually means that the therapeutic effect is small, and the efficacy of the trial is not enough to give a clear answer.” Large-scale, multi-arm, master agreement studies are designed to bridge the large-scale implementation of large-scale expensive drugs by large pharmaceutical companies. The gap between expensive trials and small specialty drugs that cannot generate enough new knowledge. During the pandemic, there were not enough government-funded, ambitious, and middle ground research—a systemic flaw at the cost of life.
The PDT was updated at 11:05 AM on May 25, 21 to correct Stacey Adam’s title at the National Institutes of Health Foundation.
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