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Executive SummaryReal-world evidence (RWE) is arguably the most important healthcare data category of the 21st century. For academic medical institutions (AMCs), a well-structured RWE Program can be foundational to several strategic initiatives:Better clinical decision-making and evidence-based standards of care.Better-funded, more diverse, and more impactful research.Value-based care and health equity/SDOH programs.Meaningful engagement with employed physicians, as well as external medical practices.Proprietary highly correlated datasets available for licensing and other monetization opportunities.Lower-cost and more sustained IP development.Ethical industry funding.Deeper and sustained patient engagement A Real-World Evidence Program based on Circles adds value to each department of an AMC, clinical or research. It imposes minimal clinical burden, is low-cost and modular, and represents a profit not a cost center.About Real-World EvidenceWhat It IsIn principle, RWE can be developed from a variety of sources – EMRs, retrospective studies, and registries for example. In practice, the most valuable RWE by far is based on validated everyday clinical interventions, closely correlated to standardized long-term outcomes.ImportancePolicymakers, regulators, payers and private sector experts have all emphasized the importance of RWE for value-based care, clinical decision-making, efficient and impactful medical research and greater health equity. [1]Institutional Value CategoriesValue-Based CareValue-based care is heavily dependent on RWE – standardized outcomes assessments closely correlated with specific relevant clinical data. This is what the FDA calls “fit-for-purpose” data. ResearchAn RWE Program makes high quality, impactful research opportunities accessible to younger and the busiest of clinicians. It allows publishable and statistically significant research to be democratized. [2]Industry FundingAs indicated, recent FDA guidance supports the use of RWE in regulatory decision-making. Most major device and pharmaceutical companies support investigator-initiated studies. A Circles-based RWE Program enables substantial expansion of IIS and similar industry-sponsored studies. Dataset LicensingAn RWE Program continuously generates validated, longitudinal, and proprietary datasets directly relevant to a specific clinical and/or scientific healthcare issue. These datasets are both clinically and statistically significant, thus representing deep value to product manufacturers, AI training models and other licensees. [3] Collaboration With External Provider GroupsOutpatient procedures across all specialties will continue to move to ASCs. There is likely to be a resurgence in regional physician-owned hospitals. Governmental and patient pressure to “bend the healthcare cost curve” will only intensify. IP DevelopmentThe busy clinician is simultaneously a key source of RWE and intellectual property. A well-designed RWE Program will educate and incentivize each physician regarding IP potential of their everyday cases, as well as provide him/her the tools to capture the relevant data to support such IP without interrupting clinical flow.Health Equity/SDOH“Health equity” and “Social Determinants of Health” are increasingly important components of value-based payments. [4] An RWE Program develops datasets supporting standards of care for under-represented patient cohorts, “orphan” indications and other groups which often fall outside of quality, mainstream healthcare. Expanded Access/Compassionate UseMany newer treatment protocols and products are first administered to patients in the context of expanded access programs. [5] These are typically delivered in the context of clinical trials. Circles combine technical robustness with low cost and efficiency, allowing AMCs to undertake many more EAP interventions. Patient Engagement A successful RWE Program drives high patient compliance in long-term outcomes reporting. Benchmarc™ delivers excellent patient UX, including educational materials, data-driven reports and other communications.This positive patient engagement redounds to an AMC’s overall branding value.RWE Program ElementsClinical Grade Technical PlatformA Circles-based RWE Program is founded on the patented inCytes™ (clinician-facing) and Benchmarc™ platforms. [6] It supports HIPAA, GDPR and Part 11 compliance. Its open API allows HL7 and other integrations. As an encrypted cloud-based system, inCytes™ is customizable, scalable, multilingual, available in many languages, and accessible on any device 24/7. Clinical User ExperienceUninterrupted Clinical FlowCircles processes ensure efficient RWE generation while eliminating clinical and administrative burden. Physicians and researchers focus on what matters most to them – study design, generating causal correlations, and improving evidence-based patient care.CollaborationCircles break down the barriers among specialties, and between the laboratory and the clinic. They enable sustained and meaningful collaboration across institutional and national borders. Education and TrainingWhat are the clinically important data to capture for a particular indication? How best do I measure outcomes for this procedure and patient? How can I validate product claims? How do I measure my patients’ outcomes against those of my peers? How do I develop an evidence-based standard of care for a particular patient cohort?Asking and answering these and similar questions are at the heart of medicine, and of an RWE Program. Clinician SupportSupport for conference presentations, publication, statistical analysis, IRB submissions, grant proposals, and clinical/scientific mentorship is an important part of a Circles-based RWE Program.Sustained Clinician EngagementCircle Academies are an example of regular communication channels inherent in an RWE Program enabling researchers and clinicians to discuss study designs, results, observations, and best practices. Profit Center, Not A Cost CenterCost-EfficiencyA Circles-based RWE Program is low cost and modular. SaaS pricing ensures complete control over expenditures, no commitments, full transparency, and the ability to scale as KPIs are met. MonetizationAn RWE Program will materially improve the quality and number of research and other grant proposals. Also, as indicated, RWE datasets represent significant value for product manufacturers, payers, and other healthcare constituencies. Properly designed and executed, an RWE Program will represent a substantial financial, clinical, and scientific return on investment for an AMC.Partner, Not A VendorRegenMed works as a long-term partner in the structuring and execution of an RWE Program. It provides the ongoing support needed to minimize clinical burden. At the same time, it works with AMC leadership to ensure that the Program meets pre-agreed KPIs.‍To find out more, please contact us.Endnotes1 See for example FDA, Real World Evidence, FDA, Post-Market Surveillance Programs; The 21st Century Cures Act; NIH Grants Program For Real-World Studies; Expect To See More RWE-Based Regulatory Decisions, Robert Califf, FDA Commissioner; Use Of Real-World Evidence In Regulatory DecisionMaking, EuropeanMedicines Agency. Registries for Evaluating Patient Outcomes: A User'sGuide: 4th Edition, Agency for Healthcare and Qualityand Research, U.S. Department of Health and Human Services. Deloitte 2022 Study: RWE’s Evolution Into A TrueEnd-To-End Capability. McKinsey: Creating Value FromNext-Generation Real-World Evidence.2 See Rediscovering andRe-Imagining Medical Research.3 See Healthcare Data: Ownership, Publication and Monetization. Getting Ready For TheGenerative AI Training Data Licensing Boom. 4 See for example SocialDeterminants of Health, https://health.gov/healthypeople/priority-areas/social-determinants-health; FDA Office Of Minority Health and HealthEquity, https://www.fda.gov/about-fda/office-commissioner/office-minority-health-and-health-equity;CMS Value Based Care, https://www.cms.gov/priorities/innovation/key-concepts/value-based-care.5 FDA Expanded Access, https://www.fda.gov/news-events/public-health-focus/expanded-access. Overview of FDA’s Expanded Access Programfor Investigational Drugs, Jarow et al., https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5443564/pdf/nihms863256.pdf.CliicalTrials.gov data submissions for EAPs. https://prsinfo.clinicaltrials.gov/expanded_access_definitions.html. 6 U.S. Patent No. 11720567, Method and System For Processing LargeAmounts of Real-World Evidence.‍

Properly structured real-world evidence datasets are in great demand by product manufacturers, payers, generative AI learning models and other healthcare constituencies. They represent broader and more sustained regulatory and IP value than registries or even narrowly defined RCT datasets. RWE datasets therefore represent substantial and sustained monetization opportunities to those provider groups which develop and own them.Creating a licensable RWE dataset requires several key components. Traditionally, these requirements have represented expense, complexity, administrative burden, and substantial time commitments. These challenges have prevented smaller hospitals and provider groups from developing — and monetizing — RWE datasets. However, this need and should not be the case, especially because clinical groups represent the richest source of real-world evidence.Circles eliminate these challenges, allowing provider groups, regardless of specialty, to convert their everyday clinical data into substantial and sustained financial value.

Research is changing. Everyday clinical interactions generate volumes of unique and valuable real-world data. With the help of digital health technologies, those data can now be properly stored, linked and analyzed in a way typically only reserved for expensive studies. This leads to real-world evidence which is fast becoming recognized by the FDA [1], payers [2] and many other stakeholders for its substantial cost and other advantages compared to traditional trials. Regenerative Orthopedics and Sports Medicine “ROSM” has always selected and tested its diverse non-surgical protocols in an evidence-based manner. With the help of RegenMed, ROSM will now broaden that effort by applying focused, real-world evidence strategies against every protocol, patient and physician within its multiple locations in the greater Washington D.C. area. Dr. Imran Siddiqui, Director of Clinical Operations at ROSM, says this about the new initiative:“The field of regenerative medicine remains growing, both in size and in need for evidence-based standards. ROSM has long been a pioneer of non-surgical treatment options, and that leadership will now extend to the generation and dissemination of real-world evidence across a growing number of protocols, products and patient populations. RegenMed shared our strategic vision, and with its turnkey platforms and deep regenerative medicine experience, was the natural partner to help us design and expand this broad initiative.” ROSM’s real-evidence program will focus on deploying Circles, turnkey real-world data registries, against key anatomical treatment areas. Each Circle will capture and integrate relevant real-world data, including outcomes, interventional variables, and where relevant, biological assays, and help generate comparative real-world evidence against a wide range of products and protocols. Furthermore, ROSM will invite fellow regenerative practitioners and industry partners to collaborate within the Circles, helping to generate large, multi-centric databases which advance the field forward. Nicolas Tierney, Chief Operating Officer for RegenMed, adds:“The growing field of real-world evidence, much like regenerative medicine, is in need of standardization. By volume, ROSM is one of the leading private providers of regenerative medicine therapies within the U.S.. Those case volumes, coupled with the traditional research discipline of its expert physicians, are the necessary ingredients to generate real-world evidence which is clinically and statistically significant. We are proud to support ROSM in their efforts to innovate and improve both clinical care and research.” You can learn more about ROSMs’ new Circle library by clicking the below links. Please address all inquiries to info@rgnmed.com. Knees,Hips and Pelvis,Shoulders, Elbows, Hand and Wrist,Lumbar Spine,Neck and Cervical Spine, Foot and Ankle

EmCyte Corporation is a world leader in the design, manufacture, and distribution of integrated systems for platelet rich plasma, bone marrow cell concentrate, adipose concentrate, bone marrow harvesting and PRP analysis. EmCyte also supports Gulf Coast Biologics, led by Peter A. Everts, PhD, FRSM. GCB is a separate entity dedicated to the education and training of doctors from around the world in the evidence-based clinical use of biologics-based therapies.For well over a year, EmCyte and GCB have been using the Circles platform to develop clinically and statistically significant datasets supporting various biologics treatments for knee and shoulder pathologies. (These have included patients presenting with bi-lateral conditions.)The Circles program has involved 10 clinical investigators in North America, collected detailed clinical interventional data and long-term outcomes up to one year. At the recent annual meeting of the Interventional Orthobiologics Foundation, Imran Siddiqui, M.D. of ROSM delivered a presentation reflecting statistical as well as clinical significance based on the real-world data collected by GCB Knee Circle.As the EmCyte Circles program continues to expand, many more clinicians in North America and Europe will have access to, and be able to participate in, efficient yet powerful studies which will lead to clinical decision support and new standards of care for a variety of musculoskeletal pathologies.

RegenMed is partnering with Summus Medical Laser to establish a comprehensive real-world evidence program. Summus, a U.S. corporation, has distributed thousands of its Class IV laser systems to over fifty countries. Those systems have been used to deliver millions of treatments for a variety of indications. Summus lasers are used by physicians, chiropractors, veterinarians, and dental professionals.The initial Circle designed by Summus, in conjunction with its clinical thought-leaders, will collect and analyze real-world evidence on peripheral neuropathy from dozens of practitioners in the U.S. Each practitioner will be able to customize clinical surveys to match the realities of his/her practice, without compromising the overall clinical and statistical significance of the aggregated datasets. For example, both bi-lateral and unilateral presentations of peripheral neuropathy will be accommodated. A key part of the Summus Real-World Evidence Program will be regular reports to its clinical customers regarding trends, observations, best practices, and other correlations. These reports will be supplemented by livestreamed sessions among Circle members to review learnings, comments, and questions. In addition, RegenMed will regularly provide to Summus separate reports on patient compliance, clinical customer metrics, correlations suggesting new indications, potential product improvements, and other data-driven observations. In parallel with the growth of the peripheral neuropathy Circle, the Summus Real-World Evidence Program will expand to offer additional Circles across a variety of indications and international regions.