An Expanded Access Program (EAP) allows physicians and patients access to pre-approval, investigational drugs outside of the clinical trial setting. An EAP can also be called a Managed Access Program (MAP), Early Access Program, or Compassionate Use Program (CUP).

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
  • If there are approved treatments available, the patient has tried them, and they have been ineffective
  • It is not possible to enroll in an active clinical trial

Fundamentally, there must be an unmet clinical need. The provision of a drug through expanded access can only be granted by the drug manufacturer (sponsor) – no regulatory body or third-party provider can facilitate access without sponsor approval. Please refer to either our Patient and Physicians or Sponsors section below for further information related to your EAP needs.

An Expanded Access Program (EAP) allows physicians and patients access to pre-approval, investigational drugs outside of the clinical trial setting. An EAP can also be called a Managed Access Program (MAP), Early Access Program, or Compassionate Use Program (CUP).

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
  • If there are approved treatments available, the patient has tried them, and they have been ineffective
  • It is not possible to enroll in an active clinical trial

Fundamentally, there must be an unmet clinical need. The provision of a drug through expanded access can only be granted by the drug manufacturer (sponsor) – no regulatory body or third-party provider can facilitate access without sponsor approval. Please refer to either our Patient and Physicians or Sponsors section below for further information related to your EAP needs.

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. 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 cannot receive drug through expanded access without drug manufacturer approval. For more information on the companies currently providing expanded access use of their products, check out following websites:

Patients and physicians can also visit a company website and look for their expanded access policy. All companies with products in phase 2 or phase 3 clinical trial in the US are required to have an expanded access policy on their website.

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:

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. 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 cannot receive drug through expanded access without drug manufacturer approval. For more information on the companies currently providing expanded access use of their products, check out following websites:

Patients and physicians can also visit a company website and look for their expanded access policy. All companies with products in phase 2 or phase 3 clinical trial in the US are required to have an expanded access policy on their website.

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:

SPONSORS

EAPs are regulatory approved programs that allow sponsors to make their pre-approval products available to patients outside the clinical trial. EAPs offer a variety of benefits to companies, including the opportunity to:

  • Further assess a drug prior to the full launch

  • Generate additional safety and real-world data that helps in understanding how the drug will be used in clinical practice

  • Manage risk in the pre-launch setting through appropriate adverse event capture and patient screening to ensure the correct cohorts are selected to take the medicine

  • Provide physicians with experience using the new medicine, creating advocates for the drug prior to its launch

  • Build relationships with both doctors and patients which facilitates brand loyalty

Under the 21st Century Cures Act, all companies with investigational drugs in phase 2 or phase 3 clinical trial must now have an expanded access policy 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.

Our end to end EAP Delivery includes the following services:

  • Dedicated Project Management
  • Protocol Writing

  • Physician and Patient Request Management
  • Physician Training and Support
  • Medical Oversight

  • SAE Reporting

  • Regulatory Approval Management

  • Ethics and IRB Approval Management

  • Patient Advocacy Engagement

  • Real World Data Collection

  • EAP Site Monitoring

  • Product Warehousing & Distribution

  • Transition Plan to Approved Drug under an NPP

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 contact us at:

SPONSORS

EAPs are regulatory approved programs that allow sponsors to make their pre-approval products available to patients outside the clinical trial. EAPs offer a variety of benefits to companies, including the opportunity to:

  • Further assess a drug prior to the full launch

  • Generate additional safety and real-world data that helps in understanding how the drug will be used in clinical practice

  • Manage risk in the pre-launch setting through appropriate adverse event capture and patient screening to ensure the correct cohorts are selected to take the medicine

  • Provide physicians with experience using the new medicine, creating advocates for the drug prior to its launch

  • Build relationships with both doctors and patients which facilitates brand loyalty

Under the 21st Century Cures Act, all companies with investigational drugs in phase 2 or phase 3 clinical trial must now have an expanded access policy 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.

Our end to end EAP Delivery includes the following services:

  • Dedicated Project Management
  • Protocol Writing

  • Physician and Patient Request Management
  • Physician Training and Support
  • Medical Oversight

  • SAE Reporting

  • Regulatory Approval Management

  • Ethics and IRB Approval Management

  • Patient Advocacy Engagement

  • Real World Data Collection

  • EAP Site Monitoring

  • Product Warehousing & Distribution

  • Transition Plan to Approved Drug under an NPP

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 contact us at:

FAQs

Please check out our Expanded Access Program FAQs page for answers to our most frequently asked sponsor and patient questions.

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