Published by Michael Tierney
January 16, 2020
Recent years have seen a deeper appreciation of which healthcare data have value, and which are nothing more than “digital snake oil” (see this interview with the C.E.O. of the American Medical Association). The U.S. F.D.A. and the European Medicines Agency have stressed the importance of “real world evidence”, in sharp contrast to the majority of tightly constrained clinical trials undertaken by industry. This latter type of data aggregation — while expensive, lengthy and usually based on well-designed protocols — are typically dedicated to obtaining regulatory approval for a single product and indication. The conclusions drawn from these data thus have little value to broader healthcare objectives of clinicians, their patients or payers.
Meanwhile, value-based medicine, personalized medicine, narrow networks and other powerful trends in healthcare delivery all have a common denominator – the demand for real world evidence derived from broad patient populations and supporting superior, long-term outcomes. This real-world evidence can only be achieved by filtering — through the prism of independent medical science — longitudinal, integrated and verifiable “real world” data. “Real world” means not in the laboratory, but in the clinic or other relevant setting.
One sees daily where failure by industry or clinicians to support claims with real world evidence invites scrutiny from regulators, patients, the media, fellow clinicians and competitors. Fortunately, modern tools and processes allow for the efficient development of objective and indication/procedure-specific in-clinic observational protocols, as well as the ability to derived real world evidence from the resulting aggregated large “n” real world data. To find out more, contact us at email@example.com.
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Statistical Significance and Clinical Relevance are two important concepts in the field of medicine, and particularly in clinical research. Being a bit more specific, statistical significance refers to the likelihood that a result is not due to chance.
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Real-world evidence (RWE) is valuable not only for regulatory compliance, clinical decision-making and tracking adverse events. It can also drive patient engagement, profitability and professional advancement.
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In this newsletter, we summarize the work of leading physicians as they develop clinical decision support for common musculoskeletal pathologies. Through the quality improvement and pragmatic studies embedded in their Circles, those clinicians are generating sustained financial and professional value for themselves, and improving patient care, with minimum burden. Moreover, their Circles are often supported by industry.