Bioequivalence and Bioavailability Forum

Dear Laura,

❝ Hi, was wondering how P1 CROs are dealing with the COVID19 crisis, and if there is any chance to keep studies moving (in small cohorts, no overnight stays, etc).

It certainly depends on national and local recommendations, but I would say that the probability to run a study till its end in good conditions is getting increasingly close to nil, unless maybe each subject is only expected to come once. Restrictions increase almost daily. You would have a high risk that your subjects start the study but are unable to return to the site for the next period or even the next day.

More than that: in the EU and in an increasing number of countries, I'm not sure anybody can be considered healthy. A healthy volunteer is a guy who does not know yet that he's sick. Unless you quarantine all subjects and all staff members for a fortnight, and keep your fingers crossed that none of them develops any symptoms.

❝ Should HV studies considered an essential activity per the new FDA/EMA guidances, is voluteering in a Phase 1 study considered a valid reason to be outside?

Being a healthy volunteer is not a profession, so I would not tick the "professional reason" box. I think the only exception authorities would be ready to grant is for a study on an new COVID-19 drug or vaccine.

We all have to be reasonable. The more disciplined we are staying at home, the more efficient the measure will be and the shorter it will be. Stay safe. Stay at home. Even if you loose a few months of your drug development. We should take this opportunity to revise our SOPs and do all these things we never have the time to do (or don't want to do because it's a pain). But from home.