Harvard Medical School and Harvard Pilgrim Health Care Institute Researcher Has Published New Study Findings on Clinical Trials and Studies (Pragmatic guidance for embedding pragmatic clinical trials in health plans: Large simple trials aren’t …): Clinical Research – Clinical Trials and Studies

2023 JUL 04 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- Data detailed on clinical trials and studies have been presented. According to news reporting out of Boston, Massachusetts, by NewsRx editors, research stated, “There are unique opportunities related to the design and conduct of pragmatic trials embedded in health insurance plans, which have longitudinal data on member/patient demographics, dates of coverage, and reimbursed medical care, including prescription drug dispensings, vaccine administrations, behavioral healthcare encounters, and some laboratory results.”

Funders for this research include Office of Strategic Coordination; National Institutes of Health.

Our news journalists obtained a quote from the research from Harvard Medical School and Harvard Pilgrim Health Care Institute: “Such trials can be large and efficient, using these data to identify trial-eligible patients and to ascertain outcomes. We use our experience primarily with the National Institutes of Health Pragmatic Trials Collaboratory Distributed Research Network, which comprises health plans that participate in the US Food & Drug Administration’s Sentinel System, to describe lessons learned from the conduct and planning of embedded pragmatic trials. Information is available for research on more than 75 million people with commercial or Medicare Advantage health plans. We describe three studies that have used or plan to use the Network, as well as a single health plan study, from which we glean our lessons learned.”

According to the news reporters, the research concluded: “Studies that are conducted in health plans provide much-needed evidence to drive clinically meaningful changes in care. However, there are many unique aspects of these trials that must be considered in the planning, implementation, and analytic phases. The type of trial best suited for studies embedded in health plans will be those that require large sample sizes, simple interventions that could be disseminated through health plans, and where data available to the health plan can be leveraged. These trials hold potential for substantial long-term impact on our ability to generate evidence to improve care and population health.”

For more information on this research see: Pragmatic guidance for embedding pragmatic clinical trials in health plans: Large simple trials aren’t so simple. Clinical Trials, 2023. The publisher for Clinical Trials is SAGE Publications.

A free version of this journal article is available at https://doi.org/10.1177/17407745231160459.

Our news editors report that additional information may be obtained by contacting Noelle M Cocoros, Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, United States. Additional authors for this research include Jerry H Gurwitz, Mark J Cziraky, Christopher B Granger, Thomas Harkins, Kevin Haynes, Xiaojuan Li, Lauren Parlett, John D Seeger, Sonal Singh, Cheryl N McMahill-Walraven, Richard Platt.

ORCID is an identifier for authors and includes bibliographic information. The following is ORCID information for the author of this research: Noelle M Cocoros (http://orcid.org/0000-0001-7090-2761).

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