Silvia Giarcovich
☆    

Argentina,
2020-04-16 22:38
(154 d 16:05 ago)

Posting: # 21333
Views: 2,576
 

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

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


Edit: Two successive posts merged [Ohlbe]
Ohlbe
★★★

France,
2020-04-20 10:11
(151 d 04:31 ago)

@ Silvia Giarcovich
Posting: # 21337
Views: 695
 

 Impact of COVID-19 on HV trials

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:
  • having doctors and nurses visiting the home of dozens of potential volunteers for screening has a risk of spreading the virus if one of them is contaminated. Some 30% or so (maybe more) of the population carry the virus without any symptom. It might be the case of your subjects, it might be the case of the doctors and nurses. You would need to test the latter daily (they could be negative one day and positive the next);
  • would you really have a nurse stay overnight at the home of each subject ? Considering the population usually participating in BE trials, do you think they will all have a spare room at home for the nurse ?
  • most protocols require direct supervision by a MD for a number of hours after drug administration, would you really have a MD at the home of each subject ?
  • you have a crash cart, defibrillator and this type of equipment at your clinical site, will you bring them at each subject's home ?
  • how will you proceed with sample processing: bring a centrifuge and a freezer at the home of each subject ? OK, you could have someone go from one home to the next to collect the samples and process them centrally, but it will be difficult to meet the handling times in the protocol, and there is again a risk of spreading the disease.

Sorry but I think all we can do is be patient...

Regards
Ohlbe
jag009
★★★

NJ,
2020-04-21 21:04
(149 d 17:38 ago)

@ Silvia Giarcovich
Posting: # 21341
Views: 665
 

 Impact of COVID-19 on HV trials

Hi,

No. Too many uncertainties since I dont think we have a clear understanding of the route(s) of transmission yet. Also you are risking the safety of the staff (those who go to HV's home, as an example).

J
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