We’re working with outside people and groups to create appropriate trialing models and protocols, including a focus on challenge trials. We’re looking to hire at least 2 consultants for the process (medical writing, trial design experts) and at least 2 onsite medical staff with fluency in the regulatory & logistics context of wherever a trial is to be run. (Depending upon location, we may also need an IRB’s services to review and approve any trial design; definitely necessary for anything done within the US). One of the groups we are working with, 1DaySooner, has already created and published trial designs, and our trial design will be different but informed by the excellent foundation they’ve provided. We estimate that this preparatory phase will cost $500k-$1M.
An order-of-magnitude estimate for the full cost of a completed trial would depend on scale and location, but the cost for a relatively small but sufficiently powered trial in our current focus location of the Bahamas is in the $10M range.
We’re working with outside people and groups to create appropriate trialing models and protocols, including a focus on challenge trials. We’re looking to hire at least 2 consultants for the process (medical writing, trial design experts) and at least 2 onsite medical staff with fluency in the regulatory & logistics context of wherever a trial is to be run. (Depending upon location, we may also need an IRB’s services to review and approve any trial design; definitely necessary for anything done within the US). One of the groups we are working with, 1DaySooner, has already created and published trial designs, and our trial design will be different but informed by the excellent foundation they’ve provided. We estimate that this preparatory phase will cost $500k-$1M.
An order-of-magnitude estimate for the full cost of a completed trial would depend on scale and location, but the cost for a relatively small but sufficiently powered trial in our current focus location of the Bahamas is in the $10M range.