What factor must be weighed when considering expanded access for a patient?

When considering expanded access for a patient, the potential benefit versus the risk to the patient is a crucial factor to weigh. Expanded access, also known as compassionate use, allows patients with serious or life-threatening conditions to access investigational drugs outside of clinical trials when no satisfactory alternatives are available. In this context, it is imperative to evaluate the likelihood that the patient will gain significant health benefits from the investigational treatment against the potential risks associated with its use, including adverse effects or lack of efficacy.

This assessment aims to ensure that patients are not exposed to undue harm while seeking potential therapeutic options. Healthy decision-making in this context requires a thorough understanding of both the benefits the investigational drug might provide, relative to the risks of its use. Balancing these elements is key to ethical decision-making in medical practice, particularly in situations involving vulnerable populations and unproven therapies.