Interested? who to contact:
Paul Denny-Gouldson (Unlicensed)
The problem
To achieve broad adoption and positively impact health, digital medicine products require evidence to demonstrate that they are trustworthy. The quality and quantity of evidence required to deem a product fit-for-purpose are not agreed upon by industry, patient, or government stakeholders. Currently, there is no consensus on what constitutes “evidence' or what metrics should be used to distinguish high-quality evidence from low-quality evidence. Resources including the CTTI feasibility study database and the Fitabase research library have compiled evidence for digital products in an easily searchable manner. However, there are inconsistencies in study type designations in these catalogs. In order to make useful comparisons across different digital products, the field needs a standard ontology and quality metrics for categorizing evidence used to designate a tool as trustworthy and fit for purpose. Different types of studies require different approaches in their design and information in their reporting. Different quality metrics will apply to a feasibility study for a sensor prototype needs compared to a validation study for an out of the box product in a specific patient population. A framework for achieving consistency in reporting both methods and outcomes is required for the end-users of technology -- whether a pharma company, payer, or individual patient -- to make fully informed decisions on the quality of a product.
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