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Clinical Research Association Distance Education Programs KADUZEM
For Detailed Information
FDA has created a special emergency program for possible therapies, the Coronavirus Treatment Acceleration Program (CTAP). It uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.
JAMA published an article on Preserving Clinical Trial Integrity During the Coronavirus Pandemic.
On 18 March 2020 teleconference of global regulators convened jointly by the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) under the auspices of the International Coalition of Medicines Regulatory Authorities (ICMRA)
The guideline is directed to Industry, Investigators, and Institutional
A lot of clinical research started against COVID-19. Some of them are new, some of them are old drug and vaccines.
One study was initiated by Gilead in Spain and looks for IV Remdesevir in 2 age cohorts. The other study in USA compares Remdesevir with Placebo. The third study in Europe compares Remdesivir with an HIV drug combination (Ritonavir/Lopinavir) and HIV drug combination + IFN-Beta arms. The vaccine study is done in USA.