[Goose]

I would imagine the vendors will continue clinical trials because an EUA isn't an ideal way to receive compensation for a drug. Insurance companies want "approved" therapies. In some cases the EUA makes it hard to recruit patients because you don't have to be on a trial to get the treatment. In this case I think there are enough patients in the USA that won't be a problem. Could also be a problem if having a "placebo" group is considered unethical, but I would imagine a drug would have to truly and obviously be a "game changer" for that to happen.

The issue isn't what the Sponsor wants to do; it is what patients want to do once EUA is available.  Given a choice between a clinical trial with a 50/50 (or, at best, a 2:1 odds) of getting the active drug or knowing you are getting the active treatment under an EUA, most patients will elect to get the treatment.  The issue is if there is limited availability of the treatment through the EUA, and the choice facing the patient is a clinical trial or nothing.



BC

True about patient preferences if they can get access through the EUA. Doesn't it depend on what the EUA actually allows. If you can only use it in an "Emergency", it would seem that people who are not yet in serious/critical condition (and not predisposed to get that way) wouldn't qualify. I am assuming it works that way, at least in theory. A clinical trial could chose people who are sick but not in a life-or-death situation and still recruit OK.

[Goose]

I would imagine the vendors will continue clinical trials because an EUA isn't an ideal way to receive compensation for a drug. Insurance companies want "approved" therapies. In some cases the EUA makes it hard to recruit patients because you don't have to be on a trial to get the treatment. In this case I think there are enough patients in the USA that won't be a problem. Could also be a problem if having a "placebo" group is considered unethical, but I would imagine a drug would have to truly and obviously be a "game changer" for that to happen.

The issue isn't what the Sponsor wants to do; it is what patients want to do once EUA is available.  Given a choice between a clinical trial with a 50/50 (or, at best, a 2:1 odds) of getting the active drug or knowing you are getting the active treatment under an EUA, most patients will elect to get the treatment.  The issue is if there is limited availability of the treatment through the EUA, and the choice facing the patient is a clinical trial or nothing.



BC

True about patient preferences if they can get access through the EUA. Doesn't it depend on what the EUA actually allows. If you can only use it in an "Emergency", it would seem that people who are not yet in serious/critical condition (and not predisposed to get that way) wouldn't qualify. I am assuming it works that way, at least in theory. A clinical trial could chose people who are sick but not in a life-or-death situation and still recruit OK.