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.
Also Known As
There are several terms used to describe expanded access. While terminology may vary by country, company, or regulatory framework, these phrases are often used interchangeably to describe access to medicines outside of a traditional clinical trial setting.
May also be called:
- Compassionate Use Program (CUP)
- Early Access Program (EAP)
- Managed Access Program (MAP)
- Post-Trial Access Program (PTA Program)
- Named Patient Program (NPP)
There are several terms used to describe expanded access. While terminology may vary by country, company, or regulatory framework, these phrases are often used interchangeably to describe access to medicines outside of a traditional clinical trial setting.
May also be called:
- Compassionate Use Program (CUP)
- Early Access Program
- Managed Access Program (MAP)
- Post-Trial Access Program
- Named Patient Program (NPP)
EAP Case Studies
Expanded Access Program Services
Our Expanded Access Program services are designed to help Sponsors plan, launch, and manage access programs with the structure, oversight, and regulatory support required across global markets.
From program setup and physician request management to pharmacovigilance, data collection, and product distribution, our team supports each stage of the access pathway with a patient-focused, compliant approach.
- 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
- Full-Service Pharmacovigilance
- Medical Monitoring
- Patient Advocacy Engagement
- Market Access Strategy and Support
- Transition of EAP Patients to PA-NPP
Expanded Access Program Articles
Sponsor FAQs
Can a Sponsor deny a patient enrollment into its EAP?
Yes. Although less stringent than a clinical trial, an EAP will still have inclusion and exclusion criteria, set by the sponsor company.
The sponsor will reserve the right to deny access to patients who do not meet this criteria.
Can a Sponsor limit the number of patients they include in their EAP?
Yes. Sponsors sometimes chose to restrict the number of patients enrolled into an EAP, due to limited resources or product availability. However, companies need to be forthcoming with this information, by including it in their EAP Policy.
Can Sponsors collect additional information in EAP’s?
One of the benefits of providing an EAP is that companies can collect Real World Data (RWD) from patients enrolled in the program. When compiled and analyzed, this data becomes Real World Evidence (RWE) which can be used to supplement clinical trial data when seeking marketing approval for an investigational drug.
To find out more, check out WEP Clinical’s RWE offering.
Is a Sponsor required to post an EAP policy on their website?
Although companies are not required to provide EAPs, those companies with drugs in phase 2 or 3 clinical trials in the US are required to have an EAP policy posted on their website. Sponsors are permitted to include in their policy that they do not have an ongoing EAP or they are still working internally to devise a program and do not offer one at this time.
If a company does allow expanded access use, the policy must outline the process physicians should follow to request access and provide up to date contact details for physicians to use to make a request.
WEP has designed EAP Policy templates for companies to use when developing their policy. These can be accessed here.
Learn From Our EAP Experts
Insights from our experts on Expanded Access Programs
WEP Complete Perspectives
2:43
2:26
2:30
Get in Touch
If you are a Sponsor with a product in development and you require the deployment of an EAP, or if you would like to discuss distribution of your drugs to manage requests from patients/physicians, please complete the form to the right or contact us at:
We typically respond in under 24 hours.
Get in Touch
If you are a Sponsor with a product in development and you require the deployment of an EAP, or if you would like to discuss distribution of your drugs to manage requests from patients/physicians, please complete the form to the right or contact us at:
We typically respond in under 24 hours.
Helping a sponsor collect data in an Expanded Access Program to support clinical trial data
Oncology Phase 2