EAP VERSUS OLEX STUDY

Both an Open Label Extension (OLEX) study and an Expanded Access Program (EAP) can be used to provide continued treatment access after phase 3 clinical trials have ended. In some cases, an OLEX study would be the appropriate choice. However, in others, an EAP can be used as a time- and cost-effective alternative.

To help companies understand both programs and consider which would be the best option for their post-phase 3 efforts, WEP Clinical has created the table below which outlines the main differences between an OLEX study and an EAP.

OLEX

EAP

Meet FDA requirements for the collection of long-term safety and efficacy data after a pivotal trial Provide continued treatment access for patients after a pivotal trial has ended
Only open to patients who were previously enrolled in the clinical trial Open to patients who were enrolled in the clinical trial as well as new patients who were unable to enroll in the trial
A protocol is required and must have regulatory body (e.g. FDA) input and approval A protocol is only required if doing a cohort EAP or if collecting data
Site payments are required as they would be in a typical clinical trial Payments are not required. If data is to be collected, sponsors may choose to cover cost of site admin time
Serious Adverse Events (SAE) and Adverse Event (AE) reporting is required SAE reporting is required. AE reporting is not usually required
Efficacy data may be required as advised by regulatory bodies Companies can collect data if they choose but this is not a requirement
Any data collected must be included in the CSR for NDA approval Data collected is not required to be reported, but sponsors can choose to, to support their clinical trial data
Approximately 4-6 months Approximately 2-3 months
Medium/High – similar to the cost of running a clinical trial Low – significantly less than an OLEX

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EAP VERSUS OLEX STUDY

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