CLEARED (CLinical Evaluation & Assessment for REgulation of Diagnostic tests) Implementation Phase

Our network will focus on assisting the efficient and safe availability of medical diagnostic tests in the UK, by building a collaborative network of regulators, industry, people living with disease and users of tests and researchers. Efficient regulation of diagnostic tests not only assists patient and consumer safety, but also improves the nation's health, the NHS workload, industry, regulators overseeing test approvals, as well as making the UK attractive for business leadership in regulation and research. We will focus on medical diagnostic tests (often referred to as IVD In-Vitro-Diagnostics), including tests using artificial intelligence (AI) and computer apps. Planned activities Research into the regulation of diagnostic tests is important and time-critical, as the Medicines & Healthcare Products Regulatory Agency (MHRA) is planning to implement new regulations for diagnostic tests. Until now, research into evaluation of diagnostics was not prioritised. This area is challenging due to the diversity of IVD diagnostic tests (e.g. laboratory tests, self tests, AI computer apps) and the benefits claimed from tests (accuracy, costs, time, reduced patient burden). Another challenge has been innovators and manufacturers with little experience in the technical and clinical evidence required for UK regulatory approval of tests. The key activities in our network would include * Bringing a network together across regulators, industry, people living with disease and clinical end users of tests * Running network events including workshops, surveys and interviews to share * New methods, good practice, knowledge and expertise * Research methods to generate evidence for test performance to assist approval of tests by regulatory bodies, also known as regulatory science * Networking, dissemination, training * Prioritisation of challenges in diagnostic test regulation and regulatory science research needs to inform a programme of regulatory science research. We have identified three important and novel areas for new methods in regulatory science, where current research is lacking. 1\. Document templates to assist scientific sourcing of evidence on test performance for regulatory documents 2\. Development of efficient methods using statistical modelling of post-market surveillance to ensure reliability and equity of performance for ongoing use. 3\. Creating a collaborative virtual network to enhance regulatory science for enabling regulatory approval of innovative diagnostic tests in the UK Our core team brings together expertise in * Regulation of diagnostic tests (Regulatory Specifications and Requirements). * Diagnostic test evidence generation and appraisal, including AI * Ongoing engagement with MHRA and NICE