wow-inequalities/02-data/intermediate/wos_sample/68896afc8c0effe12f76f613dfe57d09-califf-robert-m./info.yaml

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