What is the difference between a clinical trial and an expanded access program?

dylan 11 Jan 2024

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The main difference between a clinical trial and an expanded access program is that the intention of a clinical trial is to conduct research to test safety and efficacy of a new drug, while the intention of an expanded access program is for a physician to provide treatment to their patient with an unmet medical need. Both clinical trials and expanded access programs have eligibility criteria to determine who can participate.   

However, the criteria of expanded access programs usually allow for a broader group of patients. This means that a patient who is not eligible for a clinical trial might be able to access a new drug via an expanded access program. Patients who enroll in expanded access programs are often the sickest patients who have exhausted other treatment options. 

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dylan 11 Jan 2024

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