No mention of the primary efficacy indicator’viral negative’, and the reduction in the incidence of severe severity is also less statistical
Press release The papers in international journals are’preclinical’ papers, and experts’ publications with ethical issues.
Researchers “According to the guidelines of the Ministry of Food and Drug Safety, only data within the scope of disclosure”
Celltrion is raising anticipation as it announces that the second clinical phase of the Corona 19 antibody treatment has been successful. However, clinical experts warned that Celltrion’s clinical trial data should be reviewed again. There is a question of authenticity. Moreover, the paper that was published in an international journal was a paper on preclinical examinations.
Celltrion countered that it only disclosed data within the scope of disclosure according to the guidelines of the Ministry of Food and Drug Safety, but the Ministry of Food and Drug Safety said there was no such guideline.
On the 13th, Celltrion announced the results of global phase 2 clinical trials of the Corona 19 antibody treatment’Recyronaju’ (CT-P59) at ‘2021 High1 New Drug Development Symposium’.
Joong-shik Um, a professor of infectious medicine at Gachon University Gil Hospital, who gave the presentation, said, “As a result of administration of antibody therapy (40mg/kg), the incidence of development of mild and moderate patients to severe requiring hospitalization was 54% in all patients, and over 50 “The recovery period was also reduced by more than 3 days from 8.8 days to 5.4 days on average in all patients, and by more than 5 days in patients with moderate symptoms,” he explained.
However, the academic community raised questions about the announcement of the Phase 2 clinical trial of Celltrion. This is because Celltrion has not clearly disclosed the results of the primary efficacy evaluation index.
A clinical expert who requested anonymity said, “The most important thing in clinical trials is the trial design, and among them, the effective evaluation indicators are the ones that need to be closely looked at. As the primary efficacy evaluation index, negative conversion (viral negative conversion), which changed from positive to negative as no virus was detected anymore, was used as an index. However, nothing about this was mentioned in the presentation.
“When one media raised a question, Celltrion replied that it was in discussion with the Ministry of Food and Drug Safety. However, it is improbable that the experiment was conducted without properly setting the primary efficacy evaluation index. “In fact, it is not easy to obtain a result of success if negative conversion is taken as an index. It would have been wise to admit the clinical design failure and change the indicators in the middle. It is a kind of manipulation to be suspicious that the amount of virus has decreased as it is now. It is a question of ethics,” he added.
This is not the only problem. Some pointed out that the statistics presented by Celltrion are not reliable and will not have much meaning in the actual field.
“The sample data itself is too little. It is difficult to say that it is statistically significant because there are too few patients who go to severe disease. “It is difficult to conclude that the results are valid because there are too few samples.”
“There is too little data, and the p-value for examining the validity of statistics is too high. In general, we can say that the experiment is meaningful only if the p-value is 0.05 or less. However, the test results of Celltrion showed that the p-value was 0.05 or less only in severely ill patients over 50 years old, and also in the entire administration group. In terms of dose-specific administration groups, the p-value is also high, so it can be considered effective only in very limited circumstances. It is difficult to say that antibody treatments are very effective with this data alone.”
He said, “Celltrion was also put forward on the basis of the recovery time, but it is also questionable whether it will be effective in the field,” he said. “Antibody therapy has been shown to shorten the recovery period by 3-4 days. It has been shown to shorten. However, afterwards, the World Health Organization (WHO) recommended discontinuation of use, saying,’We cannot say that it is effective as a result of using it. He added that the data that the treatment period for patients with moderate severity was shortened by 5 days is not meaningful because the p value was not disclosed.
Celltrion’s exaggerated publicity was a fire dragon. Celltrion promoted the results of phase 2 clinical trials through a press release, stating that “the research results of antibody treatments have been published in the world’s leading scientific journal’Nature Communications’ as of January 12 (local time).”
However, the name of Professor Joong-Sik Eom, who conducted the clinical trial, cannot be found in the thesis. This is because this paper is about preclinical stage research, not phase 2 clinical trials. It is not a study applied to humans, but a treatise on animal testing.
A Celltrion official said, “This paper is a preclinical paper,” and said, “It took time and was unavoidable because of the nature of the journal.” The previous expert said, “In the press release, I should have specified that it is exactly preclinical. This is also a part that can raise questions about the ethics of the company.”
On the other hand, as controversy persisted over the reliability of the data for phase 2 clinical trials of antibody therapy, Professor Eom, who participated in the clinical trial, came to an explanation. Prof. Eom said through an interview with a media, “Only the parts that fall within the scope of disclosure were announced according to the guidelines of the Ministry of Food and Drug Safety.” “We submitted raw data (raw data) to the Ministry of Food and Drug Safety for review by the Ministry of Food and Drug Safety. In progress. In the future, details are expected to be disclosed through consultation with the Ministry of Food and Drug Safety.”
However, as a result of the report on Farm News, the position of the Ministry of Food and Drug Safety was different from Professor Eom’s explanation. An official from the Ministry of Food and Drug Safety responded to the reporter’s question, “The Ministry of Food and Drug Safety entrusted the disclosure of clinical trial data to the company,” and “I do not know what the guidelines mentioned by Prof. Um specifically mean, but the restrictions on data disclosure by There was no.”
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