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For most clinicians, medicine is a business as well as a calling. This is true for employed, as well as those with independent practices. Costs may include rent, staff, marketing, IT systems, capital equipment, consumables and/or continuing education. Income may include fees-for-service, RVU’s, salaries, grants, honoraria, investigator fees, and/or “value-based” payments.Unfortunately, neither medical school nor clinical practice prepares doctors for the business of medicine. Although U.S. healthcare expenditures are $4.3 trillion – over 18% of the country’s GDP – practicing physicians receive an ever-shrinking portion.Circles not only provide powerful clinical utility; they represent a substantial and transparent return on investment. That investment is only $500 for the first Circle, $35 per month and $5 per Case. Moreover, the Circles license can be terminated any time upon thirty days’ written notice.The return on that investment, with minimal clinical burden, includes:At least 12 months of physician-defined outcomes capture for each $5 Case: Make better clinical decisions. Identify potential adverse events early.At least 12 months of sustained and meaningful patient engagement for each $5 Case: Improve patient retention. Acquire new patients. Earn better reviews.Valuable aggregated datasets: Establish evidence-based approaches for new indications, protocols. Support reimbursement. Comply with legal/regulatory requirements. Support grant proposals.Better relationships with product manufacturers: Earn honoraria, investigator fees, study-based product discounts, conference support.Professional education: Collaborate with peers and experts within or across institutional and national boundaries. Test personal clinical hypotheses.Publication and Influence. Generate fresh and evidence-based content for articles, conference presentations, practice website, posts, journals, social media.Circles can convert the real-world data inherent in your everyday Cases into a sustainable profit center. Join A Circle today, or contact us to find out more.

All the power of modern social media channels, but with the security, focus and collegiality of medical conference break-out sessions. Present, discuss, teach and learn. Easily find clinical, scientific and professional topics of interest. Moderated "Spaces" open only to credentialed clinicians. Product-agnostic. Free.Private chats, livestream events, multimedia content. Content based on real-world evidence generated by your peers from their everyday practices.‍Each Space dedicated to a specific indication and/or clinical protocol. Create your own Space, or join others. Set access permissions for each Space.Access Industry Spaces for product information, training, investigator fees, honoraria, product discounts, other opportunities.‍RegenMed support: Multimedia content. Multi-channel distribution. Practice website pages. Engagement with industry. Technical. For more information, contact us at circleacademies@rgnmed.com.To join the Real-World Evidence Circle Academy,click here.

Collaborative clinical solutions for generating real-world data, evidence and value.The Clinical Value of Real-World EvidenceYour daily clinical interactions are a trove of real-world data which current systems fail to capture and exploit. Meanwhile, real-world evidence, derived from real-world data, is increasingly sought by regulators, manufacturers, payers, patients and your peers. Therefore, capturing and converting relevant real-world data into your real-world evidence represents an integral path towards achieving your personal, professional and academic goals, including:Patient Marketing and Engagement Presentations and PublicationsSponsored Studies and Trials Legal and Regulatory CompliancePractice Growth Clinical Decision-MakingReal-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions.July 2021 FDA.gov‍The Solution in CirclesCircles, built by and for practitioners, combine clinical-grade electronic data capture technology with secure international and inter-institutional collaboration. They are simple, burden-free and engaging solutions for the generation and dissemination of clinically relevant real-world evidence. Practitioners from around the world entrust their studies, trials, registries, collaboratives, and more to Circles. Contact us to learn more about Circles.

Practitioners are increasingly being asked, instructed and/or incentivized to join data registries. These collaborative solutions allow practitioners to capture, aggregate and correlate unique real-world data not native to their EMR/EHR systems, including patient-reported outcomes. There is no shortage of solutions, many with dizzying levels of features, integrations, pricing models and clinical specializations.The following article summarizes our decade’s worth of experience in developing, (failing) and ultimately succeeding in building hundreds of growing registries around the world. In those ten years, we also have had a chance to learn a lot about the market, competitors, shifting regulations, and the nuances of evolving patient privacy policies, including the new Global Data Privacy Regulations.We have distilled those experiences into 5 simple questions, whose diverse answers will surprise you, and ultimately help you make the best registry choice for you and your patients.1. Who owns the Data?The data is valuable, especially so when aggregated by many investigators against a shared protocol. If you’re putting in the work, do you at least own the data? The answer can be complex.First, not all data are equal. Information which clearly identifies the patient (Personal Information in Europe and Protected Health Information in the U.S.) is often considered exclusively “owned” by the patients themselves. If a vendor claims that you own all data in a registry, it can be inaccurate and/or a direct breach of local privacy laws. Therefore, your primary goal should ownership of anonymous or de-identified data sets.Second, there are numerous stakeholders within a registry: investigators, patients, external funders and the registry vendor themselves. You may be an owner of your data, or even more likely, a co-owner among many other stakeholders. The GDPR recommends entering in an “aggregated data ownership agreement” to clearly lay out commercial and other rights among multiple stakeholders. We recommend the same.Lastly, ownership, monetary rights and distribution rights are three independent elements, each of which should be spelled out in an appropriate agreement. What good is ownership if you can’t use it and/or don’t have a share in any monetary value? In summary, don’t just ask “Who owns the data”, make sure you sure you understand the nuances around which data, co-ownership models, and rights with respect to ownership, monetization AND distribution.2. What does it cost?If you are participating in a registry, you will be dedicating time, energy and valuable staff resources to begin enrolling patients and entering data. Some registry vendors will additionally ask that you pay a license or other fee to use their solution. You’ll have to therefore weigh the net costs: pricing, your time + staff time, against the perceived value of the registry itself. You will want to also consider the revenue model of each vendor. All companies live and breath by profit, and their revenue model is a good indicator of where they will focus their time and energy. For example, if they have high upfront installation fees, and low recurring subscriptions, you might expect excellent service initially, with low, cost-saving service and support longer-term. Look for revenue models which are aligned with the ways you obtain value. The more aligned, the more incentivized the vendor is to help you extract the most out of your registry use and data.Finally, some registries are made free to use by practitioners, with fees covered by grants and other third-party sources. We think this is great, but make sure you re-read question 1 above. Third-party funders almost always have exclusive rights to data ownership, monetization and/or distribution.3. What can I get out of it?Boilerplate answers will include data, engagement, collaboration, or even, “your colleagues are doing it.”. If those sound fuzzy, unappealing and a far cry from immediate clinical, financial and professional value, you’re right. Proper use of registries can provide substantial benefits, but if your vendor can’t articulate those, then either you aren’t the beneficiary, or its up to you to put together all the pieces. Here are three tangible benefits any registry should be able to offer:Value and Reimbursement: Registry participation offers clear commercial benefits to its practitioners. Through federally funded programs such as Merit-based Incentive Payment System “MIPS”, or grants through Industry or other third-parties, there are plenty of opportunities to earn compensation for your registry participation and time. Choose a vendors who knows these opportunities, and can offer a clear pathway for how they can help you achieve those benefits. Professional Advancement: You should see a clear path for how the registry gathers data, data converts into evidence, evidence converts into insights, and how those insights directly improve your clinical, scientific and patient marketing objectives. If you are only there to provide and access data, you are two-to-three steps away from actionable insights.Expanded Academic Influence: Registries aren’t only an opportunity to collect data, but to also to collaborate and expand your academic influence amongst peers around the world. If you are the 1,000th member of a large registry, you are helping the registry founders expand their own Academic influence. Consider instead starting your own registry, with your own select group of collaborators, and earn your own expanded influence.4. Is your solution flexible?Registry flexibility is key for sustained or expanded adoption. Conversely, inflexibility can add time or burden, decrease the value and relevance of your participation, and in many cases, be prohibitive to further use.Every vendor will claim flexibility, but with so many potential areas to customize, are unlikely to cover all, including: Assessments eCRFs and Questions Follow Up TimepointsBranding Patient Communications/Experience Multiple Languages Data Sharing Settings Report Generation and ExportsUser Roles and Permissions eConsent Language PHI/PI storage User Authentication And much, much more Make sure you know in advance the level of flexibility you need, how it applies to your goals (see question 3) and request the following three critical follow ups: can you do it, how long will it take, and will it cost extra? 5. Ask for a reference.This is standard for hiring a new employee, but is conspicuously uncommon for choosing a registry solution. If you wish to truly peer under the hood of any prospective technology, ask first to speak with a few of their clinical users, or even better, with those clinician’s staff members responsible for its use. They will be refreshingly honest about the burdens, experiences and/or benefits they and/or their patients experience on a regular basis. While on the phone, feel free to ask some of the questions above for fresh perspective.

TABLE OF CONTENTS‍ SUMMARY MARKET CHALLENGES ILLUSTRATIVE USE CASES Regulatory New Drug Applications Consumer Studies Post-Market Surveillance Research Improve Distributor Relations and Effectiveness Engage With and Attract Clinical Influencers Branding, Marketing New Indications Sustained Consumer Engagement ReimbursementCIRCLES-BASED REGISTRIES General Circles For RegistriesSummaryTwo major trends in healthcare have important regulatory and marketing significance for the OTC drug and nutraceutical markets. These are registries and real-world evidence.Real world evidence is not only an adjunct to traditional clinical trials; it is often of primary importance in supporting safety and efficacy. Registries, properly constructed, provide large databases of real-world data from which statistically and clinically significant correlations can be derived.RegenMed’s Circles provide a turnkey registries solution allowing industry participants to drive sustained return on investment in the context of their research operations, regulatory affairs and provider/consumer engagement.Market ChallengesThe OTC drug and nutraceutical markets share several characteristics, including:High growth rate; dynamically evolving markets.Strong competition, placing a premium on branding and marketing.Increased regulatory oversight and scrutiny of marketing claims.High research costs, and lengthy time to market.Criticality of distribution systems.Increasingly discerning consumers.Illustrative Use CasesThe establishment of registries by companies in the OTC drug and nutraceutical spaces can support the following:RegulatoryNew Drug ApplicationsRandomized, controlled clinical trials will always have their place in NDAs. However, regulators, payers and providers also recognize the value of verifiable real-world evidence. Such RWE derives from, for example, pragmatic trials, observational studies, case series and quality improvement studies.Registries can apply a common study design to a large number such studies. This in turn generates statistically and clinically significant correlations faster, and at a lower cost, than traditional approaches. In some instances, such registries may be sufficient to meet regulatory needs; in others, they are important adjuncts.This approach is effective for traditional as well as Abbreviated NDA’s. Consumer StudiesOTC drug companies may be required to conduct label comprehension, self-selection, actual use and/or human factor studies. These provide assurance to the regulatory body that the consumer is able properly to assess and use the product in the absence of healthcare provider guidance. Registries are an economical way to do so. Post-Market SurveillanceThe U.S. post-market surveillance programs may apply to OTC drugs. Properly structured registries are an efficient approach to conducting such surveillance.‍ResearchAn important characteristic of real-world data is its large n-value. In principle, this allows for not only the conformation of pre-supposed clinical/scientific hypotheses, but also the identification of “serendipitous” correlations. Moreover, real-world evidence registries can substantially reduce the cost of patient and investigator enrollment and follow-up. Improve Distributor Relations and EffectivenessDistributors are typically the critical connectors between manufacturers and providers and/or consumers. In the competitive environment of OTC drugs and nutraceuticals, distributors seek manufacturers with the most compelling products, marketing strengths and brand stories. The registry use cases described in this article give distributors substantive, fresh and evidence-based talking points for their interactions with providers, pharmacies, and consumers.Engage With and Attract Clinical InfluencersHealthcare professionals increasingly recommend OTC drugs and nutraceuticals alongside ethical drug prescriptions and other treatment protocols. Demonstrating safety and efficacy is therefore not merely important in obtaining market authorization. It is critical in developing positive relationships with key clinical opinion leaders. Registries are ideal platforms through which physician or scientific influencers can be involved as study investigators, medical experts, conference speakers and other capacities.Branding, MarketingCorrelations from registries – and indeed the fact of the registries themselves – provide ongoing data-driven substance for marketing materials. Such materials can be used not only at medical conferences and articles, but in social media channels directed to providers and clinicians alike.Consumer motivation usually derives from perceived efficacy in achieving general well-being, improved aesthetics, prevention or management of chronic disease, longevity, fitness, and/or sport performance. There is indeed already a trend towards evidence-based marketing. Well designed and executed registries can capitalize on this trend.New IndicationsRegistries represent a substantial number of trial sites collaborating on a common study design in the context of the investigators’ specific clinical environments. The better the registry platform capitalizes on that collaboration, the more likely clinicians are likely to discover and develop new evidence-based indications.Sustained Consumer EngagementLeading manufacturers develop communities among their users which foster mutual support, stories, and discussion. These communities can contain their own two-way registries comprising consumer-reported outcomes, improvement against personal and group goals, physician thought-leader commentary, educational programs, etc.ReimbursementRegistries can provide payers – including employer groups and other sponsors of narrow networks – with the data they need to justify reimbursement of OTC drugs and nutraceuticals. Circles-Based RegistriesGeneralCircles represent a turnkey, integrated approach to outcome capture, studies, registries, publication, and other solutions. A successful Circle comprises two closely integrated components:inCytes™ , the Company’s proprietary technical platform.Circle Academies, which enable the collaboration, education, discussion, publication, and the “network effect” needed to realize the full potential of correlations developed through inCytes™.Circles provide excellent user experiences – and motivation -- for clinicians, patients, and other users. More information can be found on its website, rgnmed.com.‍Circles For RegistriesAs mentioned, registries are increasingly common in the healthcare world. Circles-based registries are clinical-grade, turnkey and designed and executed with sustained return on investment for the Client in mind. They represent a powerful approach for OTC drug and nutraceutical manufacturers to meet a variety of clinical, regulatory and marketing challenges.Please contact us to find out more.Copyright © 2023 Regenerative Medicine LLC