A report by World Innovation Summit for Health (WISH) on Precision Medicine (PM) suggests an action plan to the policymakers worldwide for the implementation of PM and overcoming the challenges.
The report has identified ‘Patient and public engagement’ ‘Evidence generation’ ‘Implementation’ ‘Data ownership, privacy and sharing’ and ‘International and cross-sector collaboration’ as the key action areas in this regard.
The research report was released at the last WISH summit held in November 2016 in Doha and was prepared by Dr Victor J Dzau, president, US National Academy of Medicine and his team.
According to the report, PM uses the individual information, alongside highly specific clinical information about the composition of diseases, to tailor prevention and therapies. The ability to deliver PM is growing at a rapid pace and the influx of information and rapidly advancing technologies have paved the way for what could be one of the most revolutionary transformations in healthcare.
The report highlights that the power of PM lies in its opportunity to guide healthcare decisions toward the most effective prevention of disease or treatment for a given patient, improving care quality while reducing unnecessary diagnostic testing and therapies. When applied at the population level, PM holds immense promise for public health, particularly in disease prevention and risk assessment.
However, significant challenges and barriers remain to its broad implementation and integration in medical practice globally. For PM’s potential to be fully realised, policymakers will need to address these critical challenges.
The report suggests that public education programmes should be developed at early educational stages explaining PM and related concepts, including data sharing. “Governments should build understanding and trust for PM by increasing the availability of programmes that target underserved populations. To improve health literacy, governments and funding agencies should support research to determine participants’ preferences, values and general knowledge about PM research and clinical care, and identify barriers to effective public engagement,” it says.
As for evidence generation, a flexible framework is needed to balance the use of randomised controlled clinical trials, large volumes of data and control group observations of PM. “An evidence framework is needed that includes different thresholds for initial clinical use of PM, a final approval standard and a requirement for ongoing collection of data about PM’s effectiveness. Final regulatory and funding approval could be made contingent on the inclusion of an economic impact analysis,” continues the report.
The report further recommends that a centralised global resource should be developed for implementation of PM, including information technology for optimised decision support and other analytical tools. It points out that standards for structured data or common data elements, must be developed for recording information in electronic health records. There should also be greater investment in translational health research particularly in the ‘implementation science and diffusion’ and ‘outcomes and public health impact’ phases.
About data sharing, it is highlighted that governments should develop an ethical framework that addresses the risks and concerns of patients and the general public; provide information on what privacy protection is in place and give information on how data sharing promotes the public good. "There must be greater investment in the informed consent process, including making it globally standardised and easier for patients and researchers to implement. Financial incentives could also be effective in promoting data standardisation and sharing," adds the report.
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