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Unlocking The Value Of Circles Circles create proprietary and statistically significant datasets representing value to all healthcare constituencies. Categories of value include clinical decision-making, product development, regulatory approvals, monetization, competitive differentiation, and patient and HCP engagement. Circles Co-Marketing Programs accelerate that value for both provider and industry Clients. They convert Circles into a profit center.Illustrative ProgramsClient ReportsThese regularly distributed reports cover Case numbers, cases per investigator, compliance rates, select trends against end points, clinical observations, and other quantitative and qualitive content. Client Reports also include hand-outs with verbal and graphical content for patient communications.Circle AcademiesEach Circle Academy is a secure digital venue for licensed healthcare practitioners to present, discuss and benefit from real-world evidence relating to a specific clinical theme. A Circle Academy may be thought of as a secure “always-on” medical conference, available at any time from any location and any device. Circle Member RecruitmentMost clinical Circle founders wish to attract peers to improve the statistical significance of their datasets, and discuss best practices regarding specific indications and patient populations. Most industry Circle founders wish to extend the frequency and substance of their engagement with existing and potential product users. RegenMed supports these goals through press releases, website content, social media posts, conference attendance, and other channels.PublicationThe rich and validated Circles datasets are natural centerpieces for journal articles, conferences presentations, abstracts, and professional education/training materials. RegenMed partners with Circle Founders and Members to prepare foundational materials, develop video and other derivative assets, moderate conference panel discussions, and otherwise drive maximum exposure. Continuity Of CareCircles functionality supports sustained collaboration with — and information sharing among — referring and referee clinicians, post-procedure therapists, laboratory personnel and other professionals involved in a patient’s care.The referring clinician, the specialist, and the patient all benefit from the ability to contribute to and regularly review coordinated clinical care and longitudinal outcomes measurements. The multilingual capabilities of Circles allow, for example, referring clinicians in one country to monitor their patients before and after a clinical intervention in another country.Third Party SupportRegenMed helps Circle Founders incorporate scientific experts, medical statisticians, and other third parties into their studies. Similarly, it helps coordinate work with IRBs, MECs, and other bodies required for Good Clinical Practice. Dataset MonetizationCircles datasets have substantial value due to their large n-value, long-term outcomes capture, validated data, and clinically significant causal correlations.Those datasets therefore have significant value in the context of product development, new indications, regulatory submissions, and generative AI learning models.RegenMed works closely with its Clients to help maximize the value-producing elements of their Circles, as well as identify and pursue monetization opportunities.Learn MoreClient use cases involving Circles Co-Marketing Programs can be found here, here, and here. To discuss how such programs can help advanceyour specific objectives, please contact us.

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.

The ValueReal-World Evidence (RWE) is at the heart of value-based care, impactful medical research, new product development, and health equity. To have value, an RWE dataset must be clinically and statistically significant, longitudinal, and possess internal data integrity capable of validation.The design and execution of an RWE dataset should be based on principles of good clinical practice (GCP). It must also be “fit for purpose”; that is, the protocol underlying the dataset must address a clearly articulated clinical/scientific hypothesis and one or more corresponding endpoints.Thus, the elements of a licensable RWE dataset closely resemble those of a randomized controlled trial (RCT). The major difference is that the narrow inclusionary criteria of RCTs render them irrelevant to most real-world indications and patient populations. Moreover, the expense, delay, and administrative burden of RCTs generally limit their sponsorship and value to well-capitalized manufacturers seeking one-time regulatory approval for a specific product.Real-world data – the building blocks of RWE datasets – are by definition plentiful. But the most powerful and therefore valuable RWD are to be found in everyday clinical interventions and correlated long-term outcomes.Those RWE datasets are in great demand by product manufacturers, payers, generative AI learning models and other healthcare constituencies. They therefore represent substantial and sustained licensing and other monetization opportunities to those who develop and own them.The ChallengesCreating a licensable RWE dataset requires several key components:A study design addressing a specific clinical and/or scientific issue of relevance in the current healthcare environment.A study protocol which is efficient, “fit-for-purpose”, and will generate correlations reflecting statistical and clinical significance.Experienced and motivated investigators with access to the patient populations relevant to the study design.Access to patient populations with a large n” specific to the study’s endpoints.Processes which do not interrupt the normal clinical flow of the investigators and their staff.Long-term patient compliance with outcomes reporting.Support for scientific, statistical, legal/regulatory, publication and other study-related components.Often, an Institutional Review Board or Medical Ethics Committee.Funding.The technical platform(s) supporting, investigator recruitment and collaboration, patient outcomes capture, data reporting, patient consent form tracking, regulatory compliance (HIPAA, GDPR, Part 11, etc.) and other GCP elements.These requirements can appear daunting. They can prevent smaller hospitals and provider groups from developing monetizable RWE databases.However, this need and should not be the case, especially because clinical groups often represent the richest source of real-world evidence.The SolutionCircles enable the cost efficient and minimally burdensome generation of monetizable RWE datasets. Through Circles, provider groups of any size can:Quickly set up one or more Observational Protocols underpinning a fit-for-purpose study design.Establish the elements of a study protocol which will lead to clinically and statistically significant endpoints, supported by validatable data and other GCP requirements.Identify and efficiently integrate scientific, statistical, laboratory personnel and other collaborators into the data generation process.Identify, recruit, and support sustained collaboration among clinical investigators, whether within or outside of institutional and national boundaries.Ensure no interruption of regular clinical activities for those investigators or their staff.Accommodate practice variations of each investigator without compromising data integrity.Support IRB/MEC requirements.Automatically enroll patients, obtain and record customizable patient consents, track long-term outcomes with high compliance rates, prepare and deliver ongoing patient education materials and progress reports.Attract funding.Data ownership and access at any time from any device.Generate reports, filtered against any Observational Protocol question.Meet legal and regulatory requirements.Continue and expand the RWE datasets after the attainment of original endpoints.Develop licensing and other monetization opportunities.A robust, compliant technical platform and associated processes integrating the foregoing into a single turnkey solution.The creation of monetizable RWE datasets is generally hindered by cost, delay, complexity, multiple separately managed processes, and clinical burden.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