A New Framework For Comprehensive Evidence Development
In today’s health care environment, where the volume and complexity of clinical information continues to increase for a range of stakeholders, research sponsors must understand how clinical trials, prospective observational research or registries, and retrospective data are used, what the costs are, and what a combined approach will look like. They must prepare for a more comprehensive and efficient research paradigm that provides payors, providers, and policy makers with the requisite data to make coverage and treatment decisions.
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The standards needed for reimbursement of molecular diagnostics are changing – especially with respect to genomics-based tests, with their potential impact on public health with respect to screening, prevention, and measuring response to treatment, as well as cost. As the complexity of the assay development and launch process has grown, so too has the emphasis on evidence and clinical effectiveness, as well as the importance of finding better ways to align test coding and reimbursement with clinical value. But a lack of coordination across agencies and commercial players makes an assessment of the impact of any changes on evidence demands problematic.
On its face, comparative effectiveness research and its new cousin, patient-centered outcomes research, would seem to support, if not enable, personalized medicine. But as currently established in the US, there is little conceptual overlap. That’s largely because much CER and patient-centered outcomes research steer clear of anything that smacks of the development of cost data, which personalized medicine may need to truly make its value proposition.
Sean Tunis is director of the Center for Medical Technology Policy and a leading advocate for comparative effectiveness research and evidence-based medicine. Formerly Director of the Office of Clinical Standards and Quality and CMO of the Centers for Medicare & Medicaid Services, he discusses the state of comparative effectiveness advocacy and his current work developing medical device protocols aimed at providing actionable information to physicians, patients, and payors.