Expanded Access Programs Require Top-Notch Teamwork

UBC's clinical research teams excel at speed, flexibility and collaboration

Expanded Access Programs Require Top-Notch Teamwork

For patients with a serious condition or immediately life-threatening disease who cannot participate in a controlled clinical trial, expanded access programs (EAPs) make investigational new drugs (INDs) available, under certain circumstances.  

Although the primary intent of an EAP is to provide treatment, not to obtain information, these programs also offer manufacturers an opportunity to gain insights on the future effectiveness of their drug outside of a clinical trial setting.

UBC has managed EAPs, also known as compassionate use programs, to treat many conditions, including cancer, HIV, Alzheimer’s disease, psychosis and cystic fibrosis. We’ve gained critical insights into what processes work best for enrolling patients and capturing data quickly and efficiently.  We’ve learned that teams supporting these programs should excel at three core competencies: speed, flexibility and collaboration. Let’s take a look at what makes these competencies essential to successful EAPs.

Speed:  Patient Need and Potential for Priority Review Reduce Timelines

Drugs are designated to EAPs to accelerate access to patients with severe medical conditions when no other therapies are available or if other therapies have not provided optimal outcomes.  Time is of the essence. Teams managing EAPs should understand this and have a commitment to working quickly and reducing any burdens on patients or sites that may delay enrollment.

EAPs have a much higher probability of timeline and protocol changes than other clinical research programs. Teams supporting EAPs should expect increased site volatility as well as changes to drug review timelines, which can be reduced by months if a product or device is showing promising outcomes.

Flexibility: Expect the Unexpected in Site Activation and IRB Approval

Before an eligible patient can be enrolled in an EAP, the patient’s provider must be trained, according to a manufacturer’s requirements, and have an executed contract.  In addition, each site must receive approval by its governing  Institutional Review Board (IRB) to participate in a specific clinical investigation.

Teams supporting EAPs should be proactive in collecting information needed from sites, ensuring applications are completed as quickly as possible, and following up with any unique requirements a site may have.  Teams who can quickly recognize an appropriate course of action to meet these unique requirements will be the most successful in achieving the end result needed — that is, enrolling the patient.

Collaboration: Strong Working Relationships Can Affect Health Outcomes

Teams supporting EAPs should never lose sight of the fact that every second counts when it comes to patient access to cutting-edge therapies.  Teams must build strong working relationships with healthcare providers and have solid experience working through the regulatory processes that must be followed until the product becomes commercially available. At UBC, our staff travels throughout the U.S., European Union, and other countries to ensure proper procedures are followed, data are collected and that patients continue to have access to therapy once a product is approved and moves to the commercial setting.

 It’s especially important for all teams, including data management, clinical operations, and biometrics to work together to make sure the appropriate protocol is implemented and regulatory processes are followed. These programs require frequent communication with staff to ensure healthcare providers have the information they need to treat eligible patients.

Knowing the work we do helps patients receive access to life-changing therapies, our team receives great satisfaction every time a patient is enrolled. A recent example of our strong collaboration occurred  when a physician in New York identified a patient with multiple myeloma who was a potential candidate for an investigational treatment. One of our clinical research associates was in Chicago getting ready to catch a flight home when he received a call requesting that he fly to New York ASAP for a site initiation visit. The physician’s site was in the process of enrolling in the EAP. However, it had not yet received an initiation visit, a pre-requisite for patient enrollment.

While my colleague traveled, my team and I worked to ensure the site contract, regulatory documents and consent materials were prepared, approved and signed. The initiation visit was conducted the next day and the patient, a 72-year-old man who had not responded to previous treatments of an approved product, was able to receive therapy.

Do you have an EAP-designated product that could benefit from a team with speed, flexibility, and collaboration?  Contact us to learn more about how we can help get your product to patients who need it most.