Due to a “strong disagreement” on the communication of preliminary results concerning tocilizumab and presented as positive, the surveillance committee for trials carried out in Paris hospitals (AP-HP) against Covid-19 has resigned, has indicated on Wednesday the AP-HP. This collective resignation had been revealed Tuesday evening by the Duck chained.
"For these experts, not only was it too early to draw conclusions and announce positive results, but the" conduct of this study "is marred by" many dysfunctions "such as changes in criteria along the way," writes l 'weekly, quoting an email sent on April 27 by these independent experts to the director general of the AP-HP, Martin Hirsch.
In a press release, the AP-HP confirmed this resignation, which it said was linked to the April 27 communication of preliminary results deemed positive on tocilizumab. "At a meeting held on April 30, the trial supervisory committee expressed its strong disagreement with this communication and resigned," said AP-HP. A Data Safety Monitoring Board (DSMB) is made up of experts external to a trial, responsible for regularly studying its data and advising the scientists who conduct it.
On April 27, the AP-HP communicated widely to announce that tocilizumab had shown efficacy in patients of Covid-19 in serious condition. However, the authors of the study, which is part of a larger program called CORIMUNO, had not published figures to support their claims. In addition, these first results had been communicated before their publication in a scientific journal and therefore their evaluation by other experts.
A new designated supervisory committee
The AP-HP had then argued that this early communication had been decided "for reasons of public health", due to the context of the pandemic crisis. "The investigators and the promoter AP-HP felt obliged, from an ethical point of view, to communicate this information", is justified Wednesday the AP-HP.
According to her, a "new supervisory committee" was appointed, "made up of French and international experts". He will be responsible for "monitoring the tests of the entire CORIMUNO program". In addition, "taking into account the debate on the communication of the results of the trial" on tocilizumab, this committee will have to make "specific recommendations on the time and nature of the communication of the results of each of the platform trials".
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"The APHP and the investigators have made a written commitment to strictly follow the recommendations of the new committee which will meet in the next few days," said the AP-HP. She says she is “proud” of her CORIMUNO program and “confident that the future, and the evaluation by peer-reviewed journals, will show that her results […] are important”.