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
type: article
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'