Patients & Physicians
When patients with severe illnesses cannot access an investigational product through a clinical trial, and have exhausted all available approved treatment options, EAPs may offer a means to obtain promising pre-approval drugs through compliant regulations.
Patients who wish to access an investigational drug through an EAP must have a physician willing to act on their behalf. Physician responsibilities include:
- Making the clinical decision and justification to use an investigational drug
- Contacting the drug manufacturer or WEP Clinical and requesting access to the drug
- Completing the necessary documentation for the relevant regulatory bodies (e.g. the FDA, MHRA, etc.) to provide approvals to import/administer the investigational drug
- Contacting the relevant local ethics committee (or institutional review boards in the US) to gain approval to use the product to treat the patient
- Ethical handling of patient information and consent
Patients and physicians wanting to find out more information around available EAPs can visit websites including clinicaltrials.gov, The Raegan-Udall Expanded Access Navigator, or the EU Clinical Trials Register.
WEP Clinical provides patient advocacy outreach to engage patient organizations and help bring needed treatment to patients around the world. To learn more about our experience working alongside patient advocacy groups please visit our patient advocacy page.
If you require further information, or would like help researching treatment options or reaching out to drug manufacturers, contact us at: