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Evidence generation plan for HTG10877 Technologies for diagnosing endometriosis in primary care

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1 Purpose of this document

NICE's assessment of EndoSure and Endotest recommends that more evidence is generated while they are being used in the NHS. The other technology that was assessed can only be used in research and is not covered in this plan.

This plan outlines the evidence gaps and what data needs to be collected for a NICE review of the technologies again in the future. It is not a study protocol but suggests an approach to generating the information needed to address the evidence gaps. Evidence generated through other study approaches will also be considered. For assessing comparative treatment effects, well-conducted randomised controlled trials are the preferred source of evidence.

The companies are responsible for ensuring that data collection and analysis takes place. Financial support for evidence generation may be available through the NIHR Invention for Innovation product development award. Academic support may be available through groups such as the NIHR HealthTech Research Centres.

NICE will withdraw the guidance if the companies do not meet the conditions in section 4 on monitoring.

After the end of the evidence generation period (3 years), the companies should submit the evidence to NICE in a format that can be used for decision making. NICE will review all the evidence and assess whether the technologies can be routinely adopted in the NHS.