Table 3.

Arguments for and against compassionate drug use

	Arguments in favor of compassionate drug use	Arguments against compassionate drug use
Principle of autonomy	Patients with serious illness, being autonomous, capable to give voluntary informed consent, also have a right to self-preservation of life and health	Therapeutic misconception and therapeutic optimism may often compromise clear understanding of risks involved related to unapproved interventions and may compromise the informed consent process
Principle of beneficence and nonmaleficence	Patients with terminal illness are usually expected to health benefits and may have limited relative risk (since the patient is already at risk of death)	Can lead to unexpected serious adverse events which can harm patient either physically as well as financially
Principle of justice	Impractical to include all eligible in CT (e.g., long travel distance or strict inclusion criteria). Compassionate drug use can be option for such patients and suitable pathway to get access to investigational products	There may be selective preference to request for compassionate drug use, issues related to fairness, very few to get access to compassionate drugs leading to bias

CT=Computed tomography