Ethical Issues Related to Compassionate Use. RDLA, February 26, 2014. Michael J. Werner. Overarching Principles. The situation usually arises because someone is very sick and wants access to an unapproved product outside of a clinical trial
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RDLA, February 26, 2014
Michael J. Werner
The situation usually arises because someone is very sick and wants access to an unapproved product outside of a clinical trial
FDA has policies designed to provide access to such patients
Companies are confronted with an ethical dilemma
Life threatening condition?
Other treatment options (including clinical trials)?
Are they confident product has sufficiently demonstrated safety?
Is there any efficacy data for the product?
Opinion of patient’s treating physician?