Which of the following is NOT a qualification for participation in an expanded access program?

In the context of expanded access programs, the primary purpose is to allow patients with serious or life-threatening illnesses to access investigational treatments when no satisfactory alternatives are available. Eligibility for these programs typically focuses on the severity of the illness and the circumstances surrounding the patient’s need for the investigational drug.

The qualification that the patient has a common illness is not a criterion for participation in an expanded access program because these programs are generally intended for patients with serious or rare conditions where the investigational drug may provide a significant benefit. Common illnesses, by contrast, usually have established treatment options available, making expanded access unnecessary or inappropriate.

The other criteria are crucial for participation: the investigational drug should be under active clinical development to ensure that it has not yet been fully evaluated for safety and efficacy; patients who are ineligible for clinical trials might turn to expanded access as their only option; and the determination that the potential benefits of the treatment outweigh the risks is essential to protect patient safety and to justify the use of an investigational drug outside of clinical trial parameters.