A clinical trial of REDSIE TWO-BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER IN 1063 PATIENTS, LED BY THE NATIONAL INSTITUTES OF HEALTH (NIH), WAS PUBLISHED MAY 22 ON THE WEBSITE OF THE NEW ENGLAND JOURNAL OF MEDICINE (NEJM). Although the results showed that patients in the Redcywe treatment group recovered more quickly, there was no significant effect in reducing the mortality rate.
Cao Bin: The conclusion of clinical trials in China and the United States is consistent
Preliminary findings by John Beigel, a researcher at the National Institutes of Health, and others, show that Redciewe is better than placebo in reducing recovery time (median 11 days vs15 days), which supports the use of Redciewe in hospitalized patients who require oxygen-absorbing therapy, but other treatments are needed for patients with more severe conditions.
“Considering that despite the use of Ridsywe, the mortality rate is still high, which clearly indicates that antiviral medication alone is not enough. The authors believe that future strategies should assess the combination of antiviral drugs and other treatments or multiple antiviral drugs.
In response to the National Institutes of Health clinical trial data, The Vice President of the China-Japan Friendship Hospital, Professor Cao Bin, head of the Redwest China Clinical Research Program, told the first financial reporter on the evening of May 23: “The findings of the National Institutes of Health are basically consistent with our findings, that is to say, Ridsyway has some effect, but the effect is not very significant.” “
Cao Bin also told First Financial That in a recent paper published in the New England Journal of Medicine by the National Institutes of Health, the entire paragraph cited the results of a clinical study in Redciway, China, as evidence. “The results of our trial should be compared with the results of a randomized trial in 237 patients (158 in the Redsywe group and 79 in the placebo group),” Berger and other researchers wrote. “
Professor Cao Bin and his team published a paper in The Lancet on April 29 showing that a clinical trial in the Redsiewe randomized double-blind control group and multicenter in China showed no significant efficacy in patients with severe diseases. But the clinical trial failed to complete the group of all subjects due to the end of the outbreak, with a small sample size, which did not statistically prove that Redciewe had any significant clinical benefit to patients.
But the National Institutes of Health’s clinical trials, which have modified major clinical endpoints midway through the course of the trial, have also raised objections in the industry. Cao Bin also told the first financial reporter: “The National Institutes of Health’s definition of ‘recovery’ is broader, China’s clinical trial design is more stringent.” If the same strict criteria are adopted, it is estimated that the results are negative. “
In the aforementioned new Year’s Journal of Medicine paper, the authors explain why the main outcome of the clinical trial was revised in February, but the results were then gradually realized that the course of the new coronary pneumonia was much longer than originally expected, and the statisticians involved in the trial suggested on March 22 that the clinical differences between the 15th-day Redsyway and placebo patients might not be able to accurately assess the differences between the two groups, and therefore recommended that the evaluation endpoint be changed.” “
The authors stress that statisticians are independent of the proposed changes, that they “do not know the treatment group and do not know the outcome data”; that there is a precedent for changing the way outcomes are assessed or outcome indicators for diseases that are not well known, and that the original end, now minor endpoint, has finally proved statistically significant.
Explore Redciway-anti-inflammatory combination therapy
“This study shows the effectiveness of Redciewe in patients with severe coronary pneumonia, especially in patients with severe oxygen-absorbing support, not severe patients with respiratory hyperthermia,” Gilead said in a statement after the results of the National Institutes of Health’s clinical trial were released. We hope that Gilead’s own clinical trial results for patients who need oxygen-absorbing support will be published as soon as possible. The clinical trial will compare the efficacy of the drug for 5 or 10 days. “
The FDA has approved Redsey’s emergency use authorization for the treatment of adults and children with severe neo-coronary pneumonia. Japan has also approved Ridsiewe’s mandate, and in the future Redsiewe is expected to get more european approval.
But because clinical trial data are hard to convince the community of Redciwe’s effects, the National Institutes of Health earlier this month launched a new randomized, double-blind, control group clinical trial ACCT-2, which is being conducted in more than 100 centers around the world and plans to recruit more than 1,000 patients. Baritini is an anti-inflammatory drug developed by Lilly to treat arthritis.
“The ACCT-2l clinical trial will test whether adding an anti-inflammatory drug based on The Rhedcive treatment would provide additional benefits to patients, including reducing fatality,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. “
There is no specific drug for the new coronavirus that has emerged worldwide. The flu drug faviravir and the antimalarial drug hydroxychloroquine have been shown to be ineffective in clinical trials and have side effects. Against this backdrop, Gilead Sciences is working with the U.S. government to promote the large-scale clinical use of Ridsywe, but the question of how ridsieweis drugs should be priced is a major challenge for Gilead.
Experts warn that even in the face of a pandemic, drug development should follow the rules of “evidence-based medicine” and should not be disrespected by the strict standards of clinical research because of the business interests of businesses.
“Clinical trials should remain independent and not be treated with any bias when drugs are approved for market approval, funded by drugmakers,” Michel Schmitt, director of imaging medicine at L’Hoptial Albert Schweitzer in Colmar, in the north-eastern French region, told First Business. Because it involves scientific ethics, especially when the economy is hard hit, it is more important to abide by ethical principles, so that scientific research remains independent, and maintain the credibility of research. “