Bioequivalence and Bioavailability Forum

Hi, in order to be able to start a new BE study I wonder as an exceptional consideration: 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)?

I understand this is not an easy point since Clinical centers had already been certified (by our argentinian sanitary authority) and now we are proposing just forget about certifications and allow HV to stay at home while participating in a BE study. However, we are in a world wide sanitary emergency situation that will last a lot yet, at least until we could certify safety admission of healthy volunteers at Clinical centers.

Besides the issue of alternative clinical sites -like home or a descentralized site- there is another point: how could be certified that a HV enters and finishes a BE study as a HV? One possibility would be to include a PCR / COVID-19 test both at screening and before each administration period and at the end of the study. This could be done only if the PCR / COVID-19 test is not a sanitary resource but an investigational one. Perhaps BE studies in HV could be safely carried out if a detailed risk/mitigation plan (in each step where a human subject participates) plus a PCR / COVID-19 test at several points are applied.

Thanks a lot and regards, Silvia

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Edit: Two successive posts merged [Ohlbe]