2023-09-28 14:46:10 +00:00
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abstract: 'Despite enormous advances in biomedical science, corresponding
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improvements in health outcomes lag significantly. This is particularly
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true in the United States, where life expectancy trails far behind that
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of other high-income countries. In addition, substantial disparities in
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life expectancy and other health outcomes exist as a function of race,
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ethnicity, wealth, education, and geographic location. A major
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reformation of our national system for generating medical evidence-the
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clinical research enterprise-is needed to facilitate the translation of
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biomedical research into useful products and interventions. Currently,
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premarket systems for generating and evaluating evidence work reasonably
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well, but the postmarket phase is disaggregated and often fails to
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answer essential questions that must be addressed to provide optimal
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clinical care and public health interventions for all Americans. Solving
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these problems will require a focus on three key domains: (1) improving
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the integration of and access to high-quality data from traditional
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clinical trials, electronic health records, and personal devices and
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wearable sensors; (2) restructuring clinical research operations to
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support and incentivize the involvement of patients and frontline
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clinicians; and (3) articulating ethical constructs that enable
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responsible data sharing to support improved implementation. Finally, we
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must also address the systemic tendency to optimize individual
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components of the clinical research enterprise without considering the
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effects on the system as a whole. Overcoming suboptimization by creating
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incentives for integration and sharing will be essential to achieve more
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timely and equitable improvement in health outcomes.'
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affiliation: 'Califf, RM (Corresponding Author), US FDA, Off Commissioner, White Oak
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Campus,10903 New Hampshire Ave, Silver Spring, MD 20993 USA.
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Califf, Robert M., US FDA, Silver Spring, MD USA.
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Califf, Robert M., US FDA, Off Commissioner, White Oak Campus,10903 New Hampshire
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Ave, Silver Spring, MD 20993 USA.'
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author: Califf, Robert M.
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author-email: commissioner@fda.hhs.gov
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author_list:
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- family: Califf
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given: Robert M.
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da: '2023-09-28'
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doi: 10.1177/17407745221147689
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earlyaccessdate: JAN 2023
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eissn: 1740-7753
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files: []
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issn: 1740-7745
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journal: CLINICAL TRIALS
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keywords: 'Randomized controlled trials; pragmatic clinical trials; clinical trial
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protocol; evidence-based medicine; precision medicine; healthcare
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delivery; healthcare systems'
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keywords-plus: HEALTH; CARE
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language: English
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month: FEB
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number: '1'
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number-of-cited-references: '34'
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pages: 3-12
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papis_id: b6d7279b3f827314b57435b7f43880ce
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ref: Califf2023nowis
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times-cited: '5'
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title: Now is the time to fix the evidence generation system
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2023-10-01 08:15:07 +00:00
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type: article
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2023-09-28 14:46:10 +00:00
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unique-id: WOS:000914687900001
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usage-count-last-180-days: '0'
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usage-count-since-2013: '4'
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volume: '20'
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web-of-science-categories: Medicine, Research \& Experimental
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year: '2023'
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