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NICE Tool to Help Firms With Real-World Evidence Grant Competition

Posted 16 March 2018 | By Ana Mulero 

NICE Tool to Help Firms With Real-World Evidence Grant Competition

In support of a funding competition launched in January to assess medicines, medical devices, diagnostics, and digital health technology in real-world clinical settings, the UK’s Office for Life Sciences has added an online service to aid in the application process.

UK-based small and mid-sized companies have until 21 March to complete applications and compete for a share of a government grant of £1 million (US $1.39 million) to help lay the groundwork for evaluating real-world evidence, and if eligible, for use within the National Health Service (NHS) after the competition is closed.

The aim of the funding competition – opened by the Office for Life Sciences 29 January in partnership with Innovate UK – is for companies to demonstrate how their products’ clinical performance and cost effectiveness can help achieve NHS objectives, such as reducing unnecessary use of primary and secondary care services, enabling earlier diagnoses, supporting the management of chronic health conditions and improving patient safety.

Participating companies should expect projects to have a cost between £50,000 (US $69,692) and £250,000 (US $348,460) and start by 1 June 2018 and be completed by the end of March 2019.
CE marked products that have been available in the UK market for more than five years are ineligible, and applicants are required to explain actual vs. desired product performance and cost effectiveness.

The recommended option of using this new online tool, known as the Medtech Early Technical Assessment for a gap analysis stage in the application process “provides a structured framework to help identify potential gaps in product development plans and the potential next steps to bring a product to market,” NICE said.

Other required proposal components include descriptions of feasible plans for data collections to occur within NHS, as well as evidence that these plans were developed in collaboration with the appropriate stakeholders, such as NICE and NHS England.

NICE

Categories: Regulatory News

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