Impact of COVID-19 on HV trials [Study Per­for­mance]

posted by Ohlbe – France, 2020-04-20 10:11 (366 d 06:10 ago) – Posting: # 21337
Views: 890

Dear Silvia,

» Could the Clinical step of a BE study (screening, recruiting, administration of formulations and blood samples extractions) be carried out maintaining the HV at their own homes (always with a nurse at all times and a medical doctor visiting all the volunteers, etc etc)?

Besides what you already mention (certification of clinical centres), I see several hurdles and I don't think what you propose would be feasible/acceptable for ethics committees and authorities:
Sorry but I think all we can do is be patient...

Regards
Ohlbe

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