Bioequivalence and Bioavailability Forum

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...