Expanded access can be an option for patients with serious or life-threatening diseases, who have exhausted all FDA-approved treatments, to access investigational products. If you are a patient, caregiver, or physician looking for investigational therapy options, you can begin to research and identify them on ClinicalTrials.gov.
Clinical trials give patients an opportunity to receive an investigational therapy for the purpose of research to determine if the therapy is safe and effective. Whether you know just the condition that requires treatment or you know both the condition and the investigational therapy you would like to access, you can use ClinicalTrials.gov to learn more about what products are in development, whether clinical trials are open and available for enrollment, and the eligibility criteria. You may also find whether expanded access is available for the therapy and contact information where you can obtain additional information.
This user guide will take you through the process of using ClinicalTrials.gov website for the following:
- Researching products in development based on a patient’s condition
- Finding open clinical trials
- Finding expanded access programs (EAPs)
- Finding single-patient expanded access