Thursday, July 15, 2021 5:03:20 AM
But the endpoints they’ll be measuring, according to the SAP, are available on the UK and German clinical trial sites.
why does everyone here keep saying German sites? Its not the German site.
https://www.clinicaltrialsregister.eu/ is owned and managed by the EMA the European Medicines Agency. The EMA is situated in The Netherlands if a country must be named.
https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001977-13/DE
Every EU member state has its own Competent Authority or Ethics Committee (CAEC) with the authority to allow a medical trial to be held in its country. When that medical trial is authorized by the CAEC, the CAEC uploads it to the EMA website with its recommendation to the EMA. In the case of the DCVAX trial, it was as we know Member State Concerned Germany - PEI which carries a hell of a lot more of weight than the RA from Cyprus for example.
The EMA will then review and approve or disapprove among others the endpoints + uploaded SAP (buy-in as its called in the US). Therefore all that we see here
https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-001977-13/DE
is approved, hosted and the responsibility of and by the EMA NOT Germany...
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