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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