SPONSOR CONSIDERATIONS FOR EAPs
Expanded Access Programs (EAPs) provide patients much-needed access to promising investigational drugs, outside the clinical trial setting. They are typically set up during phase 2 or phase 3 studies, to supply patients that are ineligible or excluded from the clinical trial, or once phase 3 trials have ended, to provide continued treatment access until commercial product becomes available.
EAPs offer a variety of benefits to sponsor companies, and regulatory bodies around the world encourage the use of expanded access, where and when appropriate.
If your company is developing a drug that fulfils an unmet clinical need, you may have already started receiving patient enquiries about expanded access. Now is the time to consider if and how a program could work for your product.
WEP Clinical has put together this downloadable resource that lists the kinds of questions companies should be asking when considering or planning an EAP. Please complete the form on the right to download the resource.
“They are experts in their field and, as a Sponsor, we are impressed with the services provided. Beyond being knowledgeable, detail-oriented, accountable, and effective communicators, WEP Clinical works to build and keep trust with the Sponsor.”
Rare Disease Company
Please provide your name and email address in the fields below and press the download button. You should then receive the template as a pdf in a new tab in your browser. You will also receive a link to the template in your email inbox, so you can access it again later.