E-SECRET for Industry
The E-SECRET registry captures data about medical devices used in the treatment of acute ischemic stroke, intracranial arterial aneurysms and cerebral AVM. These data can be used to assess the safety and efficacy of such devices, and can provide manufacturers with real-world data to inform health economics, research and development, internal sales and marketing, and regulatory needs. Further, data collected by the E-SECRET offer device manufacturers an opportunity to understand their device performance in specific patient populations, in order to make recommendations on best patient selection, to potentially expand labeling indications to reflect safe and effective use, or to design new devices better suited to certain subgroups.
To improve patient care, the Middle East North Africa stroke and interventional Neurotherapies Organization (MENA-SINO) have prepared to lead and to create one unified registry. E-SECRET Quality Initiative (E-SECRET-QI) . This collaboration, E-SECRET, will provide greater opportunities for collecting and analyzing data for the MENA region.
Both the U.S. Food and Drug Administration (FDA) and the European Union (EU) have emphasized the importance of real-world evidence for total product life cycle device evaluation. Data already collected as part of the E-SECRET registries provides an efficient and cost-effective route to meet regulatory requirements, including:
- Post-approval surveillance studies required by the national authorities after initial approval of new devices.
2. Label expansion for existing devices based on analysis of “off-label” device use in practice.
3. Contemporary control cases from standard care for propensity matching with new devices.
4. EU Medical Device Regulation (MDR) reports of real-world practice, including long-term follow-up.
Redcap, the technology and service provider for the E-SECRET, has extensive experience managing all such projects for industry. Custom data elements and follow-up requirements can be added to the existing E-SECRET registry if required for specific projects. Site recruitment and contracting, data monitoring, site reimbursement, data analysis and report generation are done by an experienced team at Redcap/MENASINO joint taskforce . Analyses have shown substantial cost saving for industry using the existing network of centers already collecting most of the needed data in a registry.
The E-SECRET is uniquely positioned to help device manufacturers obtain rapid, efficient, flexible, and cost-effective results.