Evidence generation plan
Closed for comments This consultation ended on at Request commenting lead permission
1 Purpose of this document
NICE's early value assessment Digital self-help for eating disorders recommends that Overcoming Bulimia Online (Five Areas Ltd) can be used in the NHS while more evidence is generated. The other technologies that were assessed can only be used in research and are not covered in this plan.
This plan outlines the evidence gaps and what real-world data needs to be collected for a NICE review of the technology 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 if these are able to address the research gap.
The company is responsible for ensuring that data collection and analysis takes place.
Guidance on commissioning and procurement of the technology will be provided by the NHS.
NICE will withdraw the guidance if the company does not meet the conditions in section 4 on monitoring.
After the end of the evidence generation period (2 years), the company should submit the evidence to NICE in a form that can be used for decision making. NICE will review all the evidence and assess whether the technology can be routinely adopted in the NHS.
How are you taking part in this consultation?
You will not be able to change how you comment later.
You must be signed in to answer questions