Making a profit from running a clinical trial

[shimonv]

Hi everyone,

A bit of an unorthodox question...

Do any of you know if it's possible to charge a hospital per procedure during a clinical trials (IRB or IDE), i.e. can a legal manufacture run a trail and make a profit?


Thanks in advance,

Shimon

 

[Randy]

A bit of an unorthodox question...

Why unorthodox? If money wasn't involved nobody would care an iota about anything.

Not sure where this lays except that anything related to your question would be between the manufacturer and the hospital.........BUT, it could possibly raise some ethics and COI issues in the future.......Shalom

 

[Ed Panek]

You want to generate revenue as the device is being investigated?

 

[shimonv]

Yap, that is the question... I am not aware of a definitive regulatory statement on this matter, buy for sure there is a potential for a conflict of interest.

I do believe it's a relevant question for small start-ups in this challenging economy. The process for 510(k) is very long and making some revenue along with a clinical trial would be very nice.