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Type image caption here (optional)The FDA has released draft guidance on the “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices”. The principles underlying this guidance have important – and advantageous – implications not only for device manufacturers but also for clinicians.The FDA states that real-world evidence (RWE) “may provide an efficient means of generating the necessary clinical evidence to support regulatory decisions”. However, the guidance also emphasizes that data quality, good clinical practice, proper study design, longitudinal outcomes data and other traditional methodological considerations remain critical.The FDA enumerates many potential sources of RWE. Nevertheless, it is clear from the guidance that only specific types of real-world data (RWD) surrounding a discrete category of clinical interventions, and causally correlated to longitudinal outcomes, will generate acceptable “study-specific derived dataset(s).”This means that busy clinicians and their patients are essential to developing the RWD which can be converted into RWE. It is those already over-worked clinicians who are best positioned to design, capture and analyze study-specific RWD. It is their patients who must report long-term outcomes against standardized assessment measures. The overriding question is: where is the time or incentive to do so?The technology and processes underlying each Circle is “fit-for-purpose”in the context of any RWE objective to comply with the FDA’s guidance. (Indeed, the U.S. patent underlying Circles is titled “Method and System For Processing Large Amounts of Real-World Evidence”.) Moreover, Circles eliminate administrative burden for clinicians in generating RWE, while developing accompanying ethical professional and financial incentives.Please contact us to find out more.

RegenMed’s December 2023 Newsletter may be found here. It summarizes many of the ways our clients around the world are generating clinical, scientific, and financial value through Circles. The Newsletter also covers select company developments.Value-based care, real-world evidence and health equity will remain forceful healthcare trends in 2024. Addressing and benefiting from these trends is the essence of our client partnerships. All of us at RegenMed wish a restful and joyful holiday season to the exemplary healthcare professionals with whom we have the pleasure of working. We look forward to expanding and deepening those partnerships in the New Year.

Type image caption here (optional)Institutional constraints can limit the ability of physicians and researchers to collect long-term outcomes, design and execute studies, develop value-based care models best suited to their patient panels, or publish. Obstacles include time and RVU pressures, funding, complex IRB processes, and access to laboratory time and scientific experts. ‍Circles address these challenges. They inherently support collaboration across institutional and national borders. Their patented functionality is clinical grade, but imposes virtually no administrative burden. Cost is minimal; indeed, RegenMed often sources investigator-initiated study funding for Circle Members.Circles thus represent a powerful yet efficient solution for observing, participating in, or even designing “external” real-world evidence initiatives.Moreover, simple “internal” Circles implementations – such as long-term capture of standardized outcomes measures – can provide substantial clinical value to employed physicians. At only $5 per Case, and with easy data import capability for institutional EMRs, the cost-benefit analysis is straightforward.

TABLE OF CONTENTS‍ INTRODUCTION USE CASES AND BENEFITS Sustained Collaboration With Mentees Medical Society Influence Support For Patient Groups Value-Based Care Registries Private Studies Health Equity and SDOH Expanded Access (Compassionate Use)EXECUTION Pilot Study Expansion User Experience FundingFOOTNOTESIntroductionPhysicians and researchers at academic medical centers can advance their professional objectives through real-world evidence. [1] However, structural barriers often hinder their ability to do so. Those barriers can include:RVU and other financial pressures.Funding constraints. Complex, lengthy IRB processes. Limited access to laboratory time, scientists, statisticians, andother experts.Inability to develop statistically significant population samples.Cumbersome or poorly suited internal IT platforms.Circles address these challenges. On the one hand, their features comply with the objectives – transparency, consents, investigator credentials, HIPAA, etc. – underlying institutional policies. On the other hand, they offer the flexibility and user experience necessary to support collaboration across institutional and national borders.Circles thus represent a powerful, efficient, and low-cost solution for designing and executing “external” yet impactful studies.‍Use Cases And BenefitsCircles use cases relevant to employed clinicians and researchers include the following.Sustained Collaboration With MenteesDepartment chairs and other mentors can continuemeaningful relationships with fellows, residents and other mentees who havemoved to other practice environments. They can build upon past work, as well asinitiate new areas of inquiry. Medical Society InfluenceInstitutional thought-leaders often serve as medical society board members or officers. These are excellent positions from which to develop research, registry,and other initiatives. Properly structured and executed, such initiatives will lead to evidence-based clinical translation of medical advances. They will also drive value for and retention of society members, and increase the society’s impact.Support For Patient GroupsAlliances, advocacy groups, athletic conferences, veterans’ organizations, and other groups coalesce strongly around specific medical conditions. Diabetes, traumatic brain injury, cognitive impairment, IVF, and PTSD are but a few examples. Institutional leaders can help such groups develop science-based recommendations for their constituencies. Value-Based Care RegistriesValue-based care is perhaps the dominant trend in 21st century healthcare delivery. Today, value means much more than lower readmission rates. Providers are expected to demonstrate long-term safety and efficacy for each category of clinical intervention. However, even the largest hospital groups rarely capture long term outcomes consistently. The clinical grade inCytes™ and Benchmarc™ platforms capture two years or more of outcomes at only $5 per Case. Those data can easily be integrated into existing EMR platforms, and thus represent a strong clinical and financial return on investment for medical centers of any size. Circles typically reflect compliance rates of 70% or higher for patient outcomes reporting. Private StudiesYounger physicians, as well as their more experienced colleagues, are often deterred from developing datasets which could support their clinical decision-making. A study need not be expensive, burdensome, or time-consuming to be impactful. Institutions often permit observational and quality control studies without undue complications. Moreover, an institution-employed physician is always free to observe – and often participate in – an existing Circle which may be relevant to them.Health Equity and SDOH”Health equity” and “Social Determinants of Health” are increasingly important components of value-based payments. [2] Circle Members can include rural providers, practical nurses, social workers or even caregivers collaborating closely with those in academic medical centers.Circle Observational Protocols can include social or other assessments and datasets in linked to more traditional clinical data.Expanded Access (Compassionate Use)Many newer treatment protocols and products are first administered to patients in the context of expanded access programs. [3] These are typically related to clinical trials. Institutional policies can make it difficult for physicians or their patients to participate in such trials. Circles enable them to do so in a transparent manner.‍ExecutionPilot StudyCircles are highly flexible. A Circles-based initiative can be implemented for minimal cost and in a short amount of time. It can also be terminated quickly. [4] This allows a Circle Founder to begin conservatively and with a minimal budget, while benefitting from the full functionality and power of Circles.ExpansionCircles are fully scalable in terms of complexity, dataset size, numbers of sites and investigators and other parameters. They can be rendered in a variety of languages without losing data integrity. Circles can accommodate – and integrate data from – clinicians, patients, laboratories, consulting clinicians and other parties.User ExperienceCircles UX for clinicians, researchers and patients is excellent. Moreover, RegenMed’s processes support sustained collaboration, investigator recruitment, patient enrollment, teaching, publication, and many other support elements. Circles protect clinicians’ data ownership. FundingThe real-world evidence generated by Circles is inherently valuable. RegenMed works closely with industry and physicians to develop investigator-initiated studies and associated compensation, honoraria and other reimbursement fairly reflecting that value.To find out more, please contact us.Footnotes1 See for example FDA, Real World Evidence; McKinsey, Creating Value FromNext-Generation Real-World Evidence; AHRQ (HHS), Registries For Evaluating Patient Outcomes, A User’s Guide.2 See for example Social Determinants of Health; FDA Office Of Minority Health and Health Equity; CMS Value Based Care.3 FDA Expanded Access. Overview of FDA’s Expanded Access Program for Investigational Drugs, Jarow et al.. ClinicalTrials.gov data submissions for EAPs.‍4 Summary pricing can be found at our What Is A Circle page. More detailed information on products, servicing and pricing can be found Product/Service Charges and Payment Terms. Copyright © 2023 Regenerative Medicine LLC

Type image caption here (optional) Are you a clinician or medical researcher with valuable clinical data sitting on excel spreadsheets or paper? Do you currently use an EDC or participate in a registry, but are eager to switch to more modern, cost-effective and flexible platforms? Have you delayed any of these decisions due to worries about loss of data, exorbitant transfer costs or simply too much hassle? Our new Circle Data Migration Solution was designed to accommodate these research portability concerns, and help streamline and advance your ongoing research initiatives. In only a few days, and for a nominal fee, we could have thousands of your proprietary patient outcomes and other data uploaded into a private Circle of your choice. Here's a brief summary of how it works: Day 1: Export and/or request a raw .xls or .csv export from your current database vendor.‍IMPORTANT: State and federal law require providers to provide patients with their healthcare data upon request. Providers who are unable to comply with those requirements due to onerous data vendor requirements are put in a difficult position.‍Day 2: Our team will facilitate the bulk upload. We can even arrange a personalized notice to your patients to notify them of the switch, and continue their long-term outcomes monitoring using Benchmarc™.Day 3: You can begin immediately accessing, analyzing and/or exporting your data within your new Circle.‍