Posted on June 9, 2016

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Sarah Carroll, NEHI

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FOR IMMEDIATE RELEASE

HARNESSING THE VALUE OF REAL WORLD EVIDENCE

NEHI Releases Recommendations on Making Use of This Information to Support Innovation

CAMBRIDGE, MA (­­­­­­­­June 9, 2016) – The Network for Excellence in Health Innovation (NEHI)  – a nonprofit, non-partisan health policy institute focused on enabling innovations that improve health, boost health care quality and lower costs – released a report today recommending key steps to seize the potential of so-called “real world evidence” (RWE) to accelerate health care innovation and transform patient care.

RWE is evidence developed from the use of drugs, devices, or other medical interventions in the “real world” – that is, when they come into use by broad groups of patients, outside the context of more narrowly structured clinical trials. This type of evidence can include everything from clinical data about how patients respond to interventions, to data from health insurance claims, or even socioeconomic data that shows how different types of patients fare.  At best, this type of evidence can help rapidly advance understanding of what interventions work best for various patients and assist in personalizing care.

RWE is an evolving field, however, and to date, there hasn’t been consensus on how best to use it alongside the “gold standard” of scientific evidence derived from prospective randomized and controlled clinical trials. So, NEHI conducted research and convened a group of multisector experts to try to find that consensus on employing RWE in the transformation of health care.

“Real world evidence, which is often gathered through observational studies, can be an extremely useful complement to the traditional ‘gold standard’ evidence -- especially at a time when we understand more than ever the complexities of patients’ individual makeups and the use of therapies in the day-to-day world,” says Susan Dentzer, President and CEO of NEHI. “If we harness the potential of real world evidence, we can shape health care decisions in ways that can help customize care to individual patients, improve health care outcomes, avoid unnecessary or even harmful care, and lead to greater value in health care spending.”

In the paper released today, NEHI describes the “change in culture” that will be needed for the health care system to take full advantage of real world evidence.  Aspects of the cultural shift will include the following:

  • Use of Consensus-backed  standards: Scientific and statistically sound standards must be developed, with broad professional endorsement, for collecting and analyzing real world data through observational studies.
  • Transparency: Analysis of real world data should be based on high standards of transparency regarding the sources and quality of data, as well as study design and analytical methods, and dissemination of findings.
  • Shared norms for application of RWE: Users of RWE, such as health plans, clinical guidelines developers, or formulary committees, also have responsibilities to be transparent and rigorous in how they apply the evidence to their decision making.

“An essential perspective of this NEHI statement conveys how RWE can expedite innovation.  Not only does RWE complement the internal validity of traditional evidence sources with the external validity of heterogeneous community-based evidence, it provides multi-stream empirical feedback to compile target user experience, identify unmet needs, and inform technology redesign.  It’s market research for innovation,” concluded Cliff Goodman, Senior Vice President and Director, Center for Comparative Effectiveness Research at The Lewin Group

Click here to read the full report. 

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About NEHI 
NEHI (Network for Excellence in Health Innovation) is a national health policy institute focused on enabling innovation to improve health care quality and lower health care costs. In partnership with members from all across the health care system, NEHI conducts evidence-based research and stimulates policy change to improve the quality and the value of health care. Together with this unparalleled network of committed health care leaders, NEHI brings an objective, collaborative and fresh voice to health policy. For more information, visit www.nehi.net. Follow us on Twitter at @NEHI_News and like us on Facebook at NEHINews.

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