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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

It has been our pleasure to know and work with Jimmy Sung, MD, JD, FACS, for over five years. In 2018, the concept of Tribeca Aesthetics was a mere dream. Within three years, however, Dr. Sung had acquired premium property in strategically located lower Manhattan, converted it into fully certified first-class medical space (including a surgical suite), and built a thriving evidence-based plastic surgery and aesthetic practice. The photograph below shows one of RegenMed’s C/SAB members, John Kennedy, MD, FRCS, and Lisa Fortier, DVM, Ph.D. with Dr. Sung looking over his plans for the new center.Tribeca Aesthetics also houses a dedicated teaching area, as well as the Futrell laboratory, named in honor of one of Dr. Sung’s mentors at the University of Pittsburgh Medical Center, J. William Futrell, M.D., FACS.In addition to his independent practice, Dr. Sung serves as a faculty member of Plastic and Reconstructive Surgery at Weill Cornell Medical College. He also actively supports the population surrounding Tribeca Aesthetics, by serving as a member of the New York City Manhattan Community Board 1.RegenMed continues to support Dr. Sung through Circles in developing Tribeca Aesthetics as a national center of excellence in the field of evidence-based plastic surgery and aesthetics. We have no doubt that Dr. Sung’s work will be increasingly impactful for his patients and colleagues.

Dr. José Miguel Catalán was in excellent company when he presented his intraosseous PRP protocols and 1yr+ Circle data at the recent Sociedad Española de Traumatología del Deporte (SETRADE) 15th biennial congress.Our friendship and partnership with Dr. Catalán dates back to 2015. He was a young doctor offering innovative regenerative medicine treatments to locals of Palma Mallorca, Spain, and we were a young company with a vision to expand and simplify real-world data collection and use. As our very first Circle member, he invested time, feedback and everyday clinical cases to help us adapt and improve. In turn, we supported his efforts in conducting real-world research, obtaining Industry support and preparing for a growing number of conference presentations.From the day we first met, Dr. Catalán has dreamed of sharing his protocols on a global stage. Today, those dreams have become realities, as he travels the world to present his techniques and real-world results with esteemed colleagues. (Catch him next at the 14th annual TOBI: The Orthobiologic Institute conference in Las Vegas, June 8th - 10th.)We applaud Dr. Catalán's vision, work ethic, and persistence, and are proud to be a partner in his journey.

TABLE OF CONTENTS‍ILLUSTRATIVE MULTICENTER STUDY USE CASES Improved Standards Of Care Clinical Decision Making Reimbursement Testing A Clinical/Scientific Hypothesis Registries Sustained Involvement Of Teaching Hospital Residents And Fellows Extend Best Practices Of Sports Medicine KOL’sFUNDINGCIRCLES AS A COMPREHENSIVE SOLUTION General Identifying Peers And Experts IRB And Other Approvals Data Collection, Aggregation, Correlations Patient Compliance And User Experience Ongoing Collaboration Publication And InfluenceCONCLUSIONCONTACT USFOOTNOTES Abstract“Impactful and professionally rewarding multicenter studies arewell within reach for all clinicians.”Illustrative Multicenter Study Use CasesThe efficiency with which multicenter studies can be designed and executed opens up a range of use cases. As but a few examples:Improved Standards of CareAn orthopedic surgeon wishes to substantiate that his specific approach to minimally invasive shoulder reconstruction is superior in safety and efficacy to the standard approach currently utilized in his hospital.Clinical Decision MakingA pain medicine doctor wishes to improve her ability to develop different treatment plans for a diverse patient population presenting with lower back pain. She wants to be able to segment her lower back pain patient panel in an evidence-based manner.Reimbursement An ambulatory surgery center wishes to support reimbursement for a particular procedure for which patients currently pay out-of-pocket. Reimbursement may come from traditional payers, or in the context of a narrow network established by the ASC with select partners.Testing A Clinical/Scientific HypothesisA clinician, intrigued by peer-reviewed literature suggesting the value of certain biologics for a specific segment of her patient panel, wishes to validate their safety and efficacy for that segment.RegistriesA regional medical society wishes to establish a registry which adds value to its members, attracts new members, attracts new industry funding in a product-agnostic manner, and simultaneously advances the mission of the society.Sustained Involvement of Teaching Hospital Residents and FellowsThe maxillofacial department of a major hospital wishes to establish a research/clinical program which not only attracts promising fellows and residents, but maintains a relationship with them throughout their careers.Extend Best Practices of Sports Medicine KOL’sA sports medicine thought leader establishes and encourages best practices among college level soccer trainers in the context of concussion protocols, by involving those trainers in his study.‍FundingTraditional studies are long, expensive and involve limited patient populations. Such studies will of course always have their place. However, as indicated above in footnote 1, there are equally legitimate, far less costly and often more impactful alternatives. Their modest budgets and clinical efficiency make funding much more accessible.In larger hospitals and clinical groups, study funding is often available from research, education, training and even marketing budgets. Another approach is Investigator-Initiated Trials. These studies are financially supported by industry, but explicitly leave to the clinician/investigator all control over study design and execution. [1] Circles As A Comprehensive SolutionGeneralCircles represent an integrated approach to multi-center studies. A successful Circle comprises two closely integrated components:inCytes™ , the technical foundation for value-added registries, studies, trials and other forms of clinical data collection.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 thus represent a turnkey solution with excellent user experiences – and motivation – for clinicians, patients,and other users. The burden on providers is minimal.Identifying Peers and Experts RegenMed plays an active role in identifying – and supporting collaboration among – practitioners sharing a common clinical/scientific interest. Those “Circle Members” can be found in the same hospital department, in study-relevant medical societies, as authors of articles and conference presentations, and among RegenMed’s network.Circle Members often include scientific and clinical domain experts who can assist with study design,education and training. They also help identify and analyze useful correlations generated through aggregated datasets. A statistician can also be a valuable member of a Circle.IRB and Other ApprovalsAs mentioned, many forms of clinically- and statistically significant studies do not require the involvement of an IRB. Examples are “observational” and “quality improvement” studies. [2]Data Collection, Aggregation, CorrelationsThe statistic power and clinical value of most multicenter studies derive from their large population sizes. This also is the foundation for uncovering “serendipitous” correlations, as well as those envisioned in the original study design. The time needed to achieve that “n” is also significantly accelerated when multicenter studies are efficiently executed.Circles enable the economical and efficient collection of real-world data within the clinical setting of each Circle Member. At the same time, Circle functionality aggregates those data in real time from all Circle Members, wherever located.That aggregated data is then available - also in real-time and at any time - to all Circle Members.Importantly, aggregated is available through a powerful Report Builder allowing any Circle Member to:filter Circle data according to any study question, and compare it to patient report outcomes or other assessment scores established as part of the Study;compare his data against those of all Circle Members;compare a particular patient’s data against those of her broader patient panel;compare outcomes of two or more patient cohorts against the same outcomes score;export raw data; andmore.Circles accommodate variations in protocols and legal/regulatory environments across various practices, while preserving the “canonicity” of all data relevant to verifiable and useful correlations in the multi-center study’s dataset. They also provide full multilingual functionality, allowing participation among like-minded members in any country. [3]Patient Compliance And User ExperiencePatient enrollment, and timely capture of their longitudinal outcomes against a standardized scoring algorithm, are essential to a successful study. The Benchmarc™ patient user experience drives consistently high compliance rates. In addition, RegenMed offers a cost-effective Service Provider Agreement, pursuant to which it handles enrollment and outcomes reporting follow-up on behalf of clinicians.Ongoing CollaborationFor many clinicians, the opportunity to collaborate with peers in other institutions and countries is an attractive aspect of multicenter studies. Ideally that collaboration is meaningful and sustained throughout the full course of the study - from the initial design through the joint generation of correlations. Circle Academies provide the secure, always-on environment allowing them to do so.Publication and InfluenceClinicians and other healthcare constituencies around the world will be interested in one or more elements of multicenter studies – hypotheses, indications involved, study protocol, tentative correlations, methods of efficient execution. These elements are compelling data-driven content for conference presentations, articles, blog posts, training/education programs and patient materials. [4]RegenMed works closely with Circle Members to develop the appropriate content, formats and distribution channels reflecting their work. [5] ConclusionMost clinicians are capable of designing and/or participating in a multicenter study. Doing so need not be expensiveor burdensome. Properly executed, such studies are professionally rewarding, and result in genuine clinical and professional value.‍Contact UsIf you have any questions about how multicenter Circles may benefit you or your institution, please contact us.Footnotes1 See our Article of Investigator-Initiated Trials here.2 A good example is the extensive AAOS Registries. See here.3 While English is common to most clinicians around the world, most are more comfortable in their native language. More importantly, patient-reported outcomes reporting and other patient-engagement elements are essential to a successful study. That engagement should be in the patient’s native language.4 Indeed, a common criticism of traditional trials is the secrecy with which they are conducted. It is often many years, if ever, before their methodologies and conclusions are published.5 See here for more information.Copyright © 2023 Regenerative Medicine LLC