Back on topic
Meanwhile the Moscow-based Association of Clinical Trials Organizations (Acto), which represents the world's top drug companies in Russia, urged the health ministry to postpone approval until after phase-three trials.
Acto executive director Svetlana Zavidova told the Russian MedPortal site that a decision on mass vaccination had been carried out after combined first- and second-phase tests on 76 people, and that it was impossible to confirm the efficacy of a drug on this basis.
76?! Any experts here know what is a usual sample test size? EDIT Okay, seems that's normal for Phase 2 testing...although it could also involve hundreds in some trials. Phase 3 should involve thousands.
And from an interview with said person:
Do Russian companies adhere to the same level of standards that multinationals follow?
I am afraid that this is not always the case, unfortunately. It is not a problem of clinical trials, but rather a problem of drug registration. Currently, we have a double standard for Russian and foreign players, in terms of registration. If we compare what is necessary for a registration dossier, the requirements for Russian companies are far more lax. International companies must present the results of international trials, a plethora of statistics, and so on. Local manufacturers need only present the results of a limited number of Russian clinical trials, on a limited population set.
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What is your final message to the international readers of Pharmaceutical Executive?
In spite of any challenges, we believe in Russia!
So if she's not that happy, maybe it's best to take notice?