Abstract
BackgroundThe translation of biomedical research discoveries into clinical practice is marked by extended timelines (averaging 17 years) and multiple sequential process steps. However, even after a drug, device, diagnostic tool or unique therapeutic procedure successfully navigates through clinical testing to approval, real barriers remain in applying and scaling the innovation in practice.MethodsMayo Clinic initiated the Transform the Practice programme to facilitate multidisciplinary team and convergence science to continuously reinvent solutions to address unmet patient needs and accelerate the application of next-generation healthcare solutions. During a 5-year period, 24 programme teams received financial resources, barrier-removing engagement from clinical and research leadership, and enhanced administrative support, including dedicated project managers.ResultsThe approach created value in facilitating consistent progress toward project objectives and resulted in multiple publications, new extramural funding sources, and implementation of new tests and services into the clinical practice. This report describes the concentrated institutional effort to accelerate the discovery–translation–application continuum in an academic medical centre and highlights successful applications and persistent obstacles.ConclusionsThe Transform the Practice approach is effective in moving high-potential research discoveries closer to implementation in the clinical practice. Its concepts, including the application of structured project management methodology, may be quickly integrated to shorten an organisation’s time to implementing its most important discoveries.
Highlights
The translation of biomedical research discoveries into clinical practice is marked by extended timelines and multiple sequential process steps
The Transform the Practice (TtP) goal team developed a process for conducting an annual request for applications (RFA)
The Management Engineering & Consulting (ME&C) analysis indicated that the main factors slowing the progress of the TtP teams were institutional barriers, absent or ambiguous resources, delays in patient recruitment, and lack of clarity about the project manager’s role
Summary
The translation of biomedical research discoveries into clinical practice is marked by extended timelines (averaging 17 years) and multiple sequential process steps. Investment in medical and health research and development in the United States reached $171.8 billion in 2016 [1], roughly 1% of the United States gross domestic product [2] This sum corresponds to more than 45% of research and development spending by. Perhaps the time to translate a biomedical research discovery is unsurprising, given the number of steps between the laboratory and bedside that are intended to protect patients from unintended harm and to ensure efficacy. Such steps are usually required by regulatory bodies; in the United States primarily by the Food and Drug Administration. For a new pharmaceutical agent, these steps include early discovery, target identification, lead optimisation, preclinical testing, investigational new drug application, multiphase clinical testing (with phases I, II, III and often IV) and, a new drug application [9]
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