The FDA's Complaint - Is This a Good Study?

The FDA later wrote, quote, you enrolled 21 indigent persons from a multi service center for the homeless into either study. After enrolling eight of these subjects, you received approval from the institutional review board IRB to enroll vulnerable subjects as described below. These individuals were unsuitable because they were economically and or educationally disadvantaged. Some subjects could not understand or follow the protocol requirements. This was the worst way to conduct a study. There's no upside. The upside is that it's cheap and it's easy if you don't care about actually performing a good study.