Expanded Access Programs
An Expanded Access Program (EAP) allows physicians and patients access to pre-approval, investigational drugs outside of the clinical trial setting.
EAPs allow sponsors to provide access to pre-approval products outside of clinical trials. These programs are unique in each country and require different levels of regulatory approval.
These programs are for patients suffering from a serious or life-threatening illness who have no viable treatment options available to them. This means that:
- There are no approved treatments available in the patient’s home country
- The patient has exhausted all approved treatment options
- It is not possible to enroll in an active clinical trial, or clinical trials have ended and patients are waiting for commercial supply
How Sponsors Benefit
- Do the right thing and provide treatment to patients with unmet needs
- Expose physicians to drug prior to commercial approval
- Give regulators an early look at a drug which may assist in commercial approval
- Collect Real World Data (RWD) which can generate Real World Evidence (RWE) — This evidence may support clinical trial data
- Gain knowledge and experience from Expanded Access Program (EAP) to design more effective clinical trials
Under The 21st Century Cures Act, all companies with drugs in clinical trials that meet the criteria for expanded access must now have an Expanded Access Policy posted on their website.
If you have a product in, or reaching, late stage clinical development for cancer or rare diseases, now might be a good time for you to start thinking about expanded access and your company’s ability to handle potential patient requests.
21st Century Cures ActAn Expanded Access Program may also be called
Compassionate Use Program (CUP)
Early Access Program
Managed Access Program (MAP)
Post-Trial Access Program
Our EAP Services
- Dedicated Project Management
- Protocol Writing and Review
- Physician and Patient Request Management
- Physician Training and Support
- Global Regulatory Management and Support
- IRB and Ethics Approval Management
- Ongoing Physician Training and Support
- Product Labeling, Warehousing, and Distribution
- Data Management / Real World Data Collection
- Data Monitoring
- Full-Service Pharmacovigilance
- Medical Monitoring
- Patient Advocacy Engagement
- Market Access Strategy and Support
- Transition of EAP Patients to Commercial Product or Paid-For Named Patient Program (PA-NPP)