April 28, 2021
The FDA has recently confirmed definitive enforcement of its regulations regarding regenerative medicine products. Effective May 31, “discretionary” compliance by manufacturers, distributors, and their clinical customers will no longer be allowed. As a result, they can expect increased scrutiny and heightened risk of public enforcement letters and penalties. Moreover, these risks are amplified by the increased focus of state authorities, and indeed concerns expressed by patients themselves, in this area.
All this underscores the importance of independent and verifiable real-world evidence, relevant documentation, and transparent, accurate communications to HCP’s and patients. This is precisely the purpose of Circles. They create and maintain -- in a cost-efficient and minimally burdensome manner – evidence-based engagement with HCP and patient communities. Those communities in turn generate critical real-world data and transparency.
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March 28, 2023
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.
March 17, 2023
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.
January 27, 2023
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.