A pharmaceutical company developing a new treatment for a rare neurodegenerative disease had to set very strict eligibility criteria for its clinical trial. As a result, there were patients who wanted to access the company’s investigational drug but found they could not enroll in the study. Because there are no approved treatments for this condition, these desperate patients were contacting the company and requesting non-clinical trial use of the product.
The company partnered with WEP Clinical to set up an Expanded Access Program (EAP) which provides the investigational drug to patients outside the clinical trial setting in a safe and regulatory-compliant manner. This kind of program allowed the sponsor to set less stringent eligibility criteria than they had enforced for the clinical trial, whilst still ensuring complete control and visibility over patient enrollment. The EAP also allowed the sponsor to provide access to patients in countries where clinical trials were set up, as well as patients in countries where trial sites were not established. WEP Clinical managed all aspects of this program on behalf of the sponsor, from patient and physician validation, EAP and IRB document submission, drug distribution, safety reporting, and administration oversight in order to prevent IP theft.