Published by Nicolas Tierney
June 27, 2019
Government regulators, providers, payers and patients increasingly recognize the potential benefits of human cell and tissue products (“HCT/P”). At the same time, they are differentiating between “good actors” and “bad actors” in the clinical delivery of those HCT/P’s. The recent U.S. federal court injunction against US Stem Cell Centers confirms the FDA’s commitment to enforcing its HCT/P regulations against clinicians it places in the latter category. That case makes clear, for example, that enzymatic digestion of adipose – commonly used to produce stromal vascular fraction – is considered more than minimal manipulation and thus subject to regulation as a drug.
The FDA HCT/P regulations in this broad field involve three foundational concepts: autologous source, minimal manipulation and homologous use. To help clinicians understand and document compliance with them, inCytes™ now includes a short survey/report addressing key elements surrounding harvest, processing and delivery of a large number of applicable cell/tissue types. The survey and report – easily modifiable for specific practice considerations – will inform regulatorily-compliant clinical protocols, support patient engagement, establish correlations with outcomes, and document protocol and regulatory compliance.
Surveys and reports, all easily customized, are available on inCytes™ for many indications, procedures and patient cohorts. New ones are created regularly, often for the specific needs of Users. Sign up for a free, custom trial today of the platform designed by clinicians for clinicians to capture and exploit true clinical evidence.
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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.