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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

Prof. Gordon Mackay is an internationally respected orthopedic surgeon specializing in ligament and tendon repair. He works extensively with high-level athletes in Europe and other parts of the world, and served as the official doctor for the 2014 Ryder Cup at Gleneagles and for the 2014 Commonwealth Games in Glasgow.Prof. Mackay maintains an active practice in the United Kingdom, and is the inventor of the InternalBrace, with the support of Arthrex. Although a busy clinician, he is committed to evidence-based medical research. This includes ongoing collaboration with eighteen leading orthopedic surgeons and consultants around the world to advance the evidence-based clinical applications for the InternalBrace. Prof. Mackay was an early and active user of Arthrex’s Surgical Outcomes System, collecting clinical and long-term outcomes data on over 5,000 patients across six separate SOS modules. When Arthrex decided to sunset SOS in August of 2023, Prof. Mackay chose Circles as his new data collection and analysis platform. RegenMed efficiently migrated onto Circles over 5,000 of his SOS cases, maintaining full data validity conforming to the original SOS modules. Through Circles, Prof. Mackay’s office maintains strong patient engagement for continuing long-term outcomes capture. His office also uses Circles for new cases.

The International Science and Nutrition Society is an international organization which brings together physicians, scientists, and other experts in complementary and integrative medicine. Its mission is to advance science-based knowledge in nutrition, nutraceuticals, phytology, and ecology. Its podcasts are listened to by thousands in North America and Europe. ISNS also works closely with RootBrands in preparing and distributing nutraceuticals and other health/wellness products.RegenMed is partnering with ISNS and RootBrands to enroll its customers in Circles which will track outcomes against their individually reported baselines. The Circles design and data analyses will involve ISNS clinicians and scientists. Long-term outcomes will be tracked utilizing a number of standardized assessments, including BMI (both metric and imperial), SF-12 Mental, SF-36 Emotional, SF-12 Physical, and SF-36 Energy/Fatigue.Initial Circles surveys will be delivered in English. To accommodate the many ISNS and RootBrands customers in countries with other primary languages, Circles will also be implemented in those languages, without compromising the integrity of the aggregated datasets wherever generated.ISNS and RootBrands keep in regular touch with their customers through newsletters and other communications. Those communications will now include reports and observations based on Circles aggregated datasets.