In this podcast, we explore a groundbreaking shift where clinical research is emerging as a viable care option, known as Clinical Research as a Care Option (CRACO). While the concept seems promising, particularly for patients with conditions like rare diseases or cancer, it introduces a host of concerns. The alignment of Institutional Review Board (IRB) goals with the essence of a clinical study becomes pivotal. If the trial's outcome is already known, it may be labeled a seeding trial, raising ethical and FDA-related red flags. Conversely, administering a drug with uncertain effectiveness to a hopeful patient brings its own set of ethical and legal challenges. 
This evolving landscape demands careful consideration and resolution of ethical and legal issues associated with integrating clinical research and care. 

Stay tuned as discussions on this innovative approach continue to unfold.

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