Expanded Access: Programs & Possibilities
- Current Expanded Access Programs
- Experimental Drugs in Phase 3 Clinical Trials
- New Uses for Old Drugs
Treatment Options for Cancer Patients
- Standard Treatment options
- Non-Standard Treatment
- Are New Cancer Drugs Better Than Existing Cancer Drugs?
Drug Development
Clinical Trials
- Why Consider a Clinical Trial?
- Clinical Trial Entry Criteria
- Pre-clinical Studies
- Phase I Trials
- Phase II Trials
- Phase III Trials
- Post-marketing Studies (Phase IV Trials)
Compassionate Use and Expanded Access
- Compassionate Use Overview
- Expanded Access Programs (EAP)
- Single Patient Access
- Cautionary Notes
- Drug Company and FDA Approval Required for Compassionate Use
Finding an Experimental Drug
- Web sites and telephone services
- News Reports
- Patient's Physician
- Patient Advocacy Organizations
- Medical Journal Articles
Getting an Experimental Drug
- Find the drug company
- Check for an Expanded Access Program (EAP)
- Ask about Single Patient Access
- Talk to the right person about Single Patient Access
- Meeting FDA requirements for Single Patient Access
- What happens if demand for the drug is greater than the supply? How does a company decide which patients will receive the drug?
- Summary
CU and EAP Resources
- Position papers from other organizations
- FDA and Congressional Events on Compassionate Use
- FDA Regulations
- FDA Guidances
- Essays and articles about compassionate use
- General information, easy reading
- Compassionate Use Resources