Time: 2024-05-31
Recommendations have been published by the Royal Statistical Society to reshape the evaluation of in vitro diagnostic tests, aiming to prevent concerns regarding the standards applied to their assessment. The report, submitted to the UK Covid-19 Inquiry, focuses on the inadequacies revealed during the pandemic and emphasizes the importance of statistical robustness in diagnostic testing. This initiative aims to ensure that future diagnostic tests, including those for infectious diseases, undergo thorough and transparent evaluations.
The working group behind the recommendations, led by Professor Jon Deeks and Professor Deborah Ashby, outlined 22 key suggestions focusing on study-design, regulation, and transparency matters in diagnostic testing. These include the need for tailored evaluations based on the test's specific use, comparison of alternative testing strategies, and collaboration with experts in revising national licensing processes.
Professor Sheila Bird from the University of Cambridge highlighted the lasting impact of previous Royal Statistical Society reports on public health matters. The recommendations in this report align with the ongoing UK Covid-19 Inquiry and the MHRA's efforts to enhance the safety of diagnostic devices. The president of the Royal Statistical Society, Dr. Andrew Garrett, emphasized the report's significance in shaping the future of diagnostic testing.
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