Expanded Access Programs
More Information
Overview
Expanded Access vs Clinical Trial
While both Expanded Access and clinical trials involve investigational therapies, they serve different purposes.
Clinical Trials
- Designed to evaluate the safety and effectiveness of a treatment
- Follow a specific research protocol
- Collect data to advance medical knowledge
- Have defined eligibility criteria
- Often include multiple participants
Expanded Access
- Intended to provide treatment access for individual patients or groups of patients
- Available when a suitable clinical trial is not an option
- Focuses primarily on patient care rather than research
- Requires approval from the therapy sponsor and regulatory oversight bodies
- May not be available for all investigational therapies
Whenever possible, participation in a clinical trial remains the preferred pathway because it helps advance scientific knowledge while providing access to new treatments.
Frequently Asked Questions
Can anyone request Expanded Access?
No. Expanded Access is typically reserved for patients with serious or life-threatening conditions who do not have satisfactory treatment alternatives and cannot participate in an appropriate clinical trial.
Is Expanded Access the same as joining a clinical trial?
No. Clinical trials are research studies designed to answer scientific questions. Expanded Access is intended to provide treatment access outside of a research study.
Will I automatically qualify if I am not eligible for a clinical trial?
No. Additional eligibility requirements apply, and the therapy sponsor must agree to provide access.
Are all investigational treatments available through Expanded Access?
No. Availability depends on the sponsor, regulatory requirements, safety considerations, and supply of the investigational product.
Expanded Access Programs
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ELI-002-102
Subjects With KRAS/NRAS Mutated Pancreatic Ductal Adenocarcinoma. Enrollment Status: Not Accepting