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TABLE OF CONTENTS‍ELEMENTS COMMON TO MOST STUDIESRE-THINKING STUDY FORMATSGOING FORWARDElements Common To Most StudiesRegenMed has had the honor of working with providers and industry around the world for many years on studies and trials. Several broad themes emerge:Clinical Burden: Most providers wish to conduct studies. Virtually all product manufacturers must regularly conduct studies.However, time requirements, cost and design/execution complexity make traditional studies prohibitively expensive for all but the best capitalized entities.Restrictive inclusionary and exclusionary criteria in study populations render most study results of questionable value for the majority of patients.Ownership of, and access to, study data are often delayed and/or restricted.Most studies are terminated prematurely or, if “completed”, do not in fact result in statistically significant, auditable datasets.Most studies which fail to reach positive are not published.What most providers, patients, regulators, and payers are looking for in studies is everyday clinical decision support. Remarkably few studies provide this support.Re-Thinking Study FormatsNational authorities recognize the negative impact on broad healthcare metrics of over-reliance on traditional forms of medical studies. The European Medicines Agency and the U.S. FDA have stressed the importance of real-world data and evidence.Similarly, the AHRQ publication Registries For Evaluating Patient Outcomes provides an independent and thorough review of efficient study formats. The 21st Century Cures Act, Right To Try Act and similar legislative initiatives are designed to expedite the availability of safe and efficacious treatment protocols and products. This means, necessarily, improving the efficiency and lowering the costs of trials and other studies.The U.S. government’s recently announced RECOVER initiative represents a major validation of the importance of more pragmatic study formats. RECOVER builds upon and expands a $1 billion “long-COVID” research initiative already underway at the U.S. National Institutes of Health. It encompasses several key elements of modern approaches to studies: Scale: Intends to sign up 48,000 individuals with and without long-COVID symptoms.Regular Reports: First one scheduled for later in 2023.Purpose: Development of evidence-based best practices and guidance for providers and patients. Development of Centers of Excellence to develop templates for care.Reimbursement: Provide datasets needed to support reimbursement by government and private payers.Patient Focus: The primary goal of RECOVER, its studies and its research are improving health of long-COVID patients (estimated in the millions in the U.S. alone).Patient Cohorts: Distinguish among specific patient groups (age-based, race-based, etc.) in terms of symptoms, etiologies, treatment protocols.Research: Answer long-unanswered questions on systemic causes underlying the wide variety of symptoms.Going ForwardThere will always be legitimate needs for randomized, controlled, double-blinded clinical trials. However, their cost and narrow scope – virtually all are now industry sponsored – implies little genuine support in everyday clinical decision-making. As the foregoing governmental initiatives imply, there are often other equally valuable study approaches with greater benefits to broader patient populations.There can be little question that contemporary technology, better clinician and patient user experiences, and thoughtful study designs can support clinical decision-making leading to better outcomes across much larger population groups. Circles are designed precisely to enable such studies of any scale or complexity – in a turnkey, clinical-grade, and low-cost manner. Please contact us to find out more.Copyright © 2023 Regenerative Medicine LLC

As reviewed in a recent JAMA article, the United States has the highest level of rural versus urban healthcare disparity among developed countries.Historically, there have been many reasons for this. Teaching hospitals tend to be located in larger cities. Their doctors and patients benefit from substantial case volumes, affiliated medical schools, research budgets, and fellowship programs. These factors help support more data-driven standards of care, in turn leading to better outcomes. However, as pointed out in the JAMA article, patients in rural settings enjoy advantages over their urban counterparts. For example, they often have healthier lifestyles, and are more likely to have regular primary care physicians.Thus, clinicians in different geographic settings have much to learn from each other. They and their patients will benefit from meaningful and continued collaboration. Circles are designed to foster this collaboration in a number of ways. For example:Musculoskeletal practitioners can easily work together across institutional and regional boundaries to develop and share clinical best practices in the use of orthobiologics for specific indications and patient cohorts.Physical therapists can develop and publish standards of rehabilitative care on the basis of large “n” datasets for specific injuries and post-surgical support.Dermatologists and plastic surgeons can jointly develop real-world evidence to support clinical decision-making in their regenerative aesthetics practice.Podiatrists can share with their patients regular post-intervention reports presenting individualized evidence-based progress against pre-clinical benchmarks, as well as against comparable patient populations across the country.Clinicians who completed residencies or fellowships in large academic centers, but are now in small practices, can continue to share learnings with former mentors in the context of jointly executed pragmatic studies.Circles are product-agnostic, built by clinicians for clinicians, minimally burdensome, and low cost. However clinicians collaborate, it is clear that doing so in a sustained and thoughtful manner is greatly to the benefit of their professional learning, and will drive better outcomes for patients in all regions of the country.Contact us to find out more.

Fellowship training is a pivotal part of many practitioners’ careers. Moreover, senior physicians consider mentorship to be among their most fulfilling professional activities. Also, hospitals invest heavily in personnel, recruitment efforts and strategic planning to implement a successful fellowship program. They, like the fellows themselves, look for a return on their investments.The benefits of fellowship are well-reported and manifold. They include clinical expertise, academic productivity, higher quality care, more time doing research, greater career satisfaction, higher success rates with grant proposals, publication, and career advancement.Unfortunately, a fellowship program lasts only one to three years. Once it is over, the realities of medical practice greatly reduce the opportunities for collaboration with peers, mentors, and researchers. It becomes much more difficult to keep up with advances in medical science and clinical best practices. For the fellows, their mentors, and the sponsoring hospitals themselves it is regrettable that the best attributes of fellowship training largely disappear once the formal program has concluded.This need not be the case. Modern platforms and processes enable efficient approaches to training, education, and collaboration across institutional and indeed national boundaries. Circles are designed and used to facilitate not only the continuation of fellowship benefits, but to build upon them for all concerned. Download our OneSheet on the topic, or contact us to learn more.

Used by providers and industry around the world.Medical thought leaders highly value mentoring young residents, fellows, and medical students. However, as those mentees move on it can be difficult to preserve the energy and productivity of the initial relationships. And collaboration during those subsequent years can be the most valuable for both sides. Circles are the ideal platform to maintain, and indeed expand, that value.Easily collaborate across institutional and national boundaries on study designs for any clinical/scientific topic, any degree of complexityEliminate challenges created by incompatible EMR systems, languages, IRB/MEC policies and individual practice variationsCapture clinical, scientific, and financial value from the real-world evidence generated daily in your and your colleagues' practicesEfficiently develop data-driven conference, educational, website, journal, and social media materialsSecure social media functionality enables active, sustained collaboration, teaching, and learningMore Benefits:Clinical grade, turnkey, integrated, flexible, minimal burdenRCT’s, pragmatic studies, IRB submissions, registries, PROMsOwn and control your datasets. Accessible from any device 24/7Excellent user experience for clinicians and patientsSupport for industry fundingLow cost. High return on investment. Up and running in days. Cancel on 30 days' noticeLarge, growing library of validated observational protocols and outcomes assessment scores. or develop your own Powerful report functionality to generate expected and "serendipitous" correlations Contact us for a demo, or to discuss your requirements.

RegenMed has the pleasure of working with independent medical practices around the world. Many of these clients face challenges regarding finance, marketing, IT, personnel management, and other fundamental business elements. This is not surprising since business is rarely taught in medical school, even at an introductory level. Moreover, business courses by themselves do not constitute business experience and judgment. While medical students, residents and fellows benefit from clinical collaboration and mentorship of senior physicians, no analog exists for clinicians dealing with harsh business realities.These business deficits make it difficult for a private practice to reach its full potential – or even survive. The resulting diminishment of independent medical practices is highly regrettable. But its root cause – a lack of preparation for business realities -- has other serious consequences. These include non-physician leadership of medical institutions, inflated healthcare costs, less choice for patients, physician “burn-out” and reduced interest in a medical career among the “best and brightest”.RegenMed Circles are product-agnostic, but certainly not business agnostic. They generate financial as well as clinical value from the enormous amount of real-world data flowing daily through their medical practices each day. Examples of such value include honoraria, product discounts, investigator fees, superior patient engagement, new service lines, and professional advancement.One important approach to any business decision is return on investment. What will I receive and when, in exchange for what I put into a particular initiative? Staff hires, IT licenses, marketing spend, device purchases, rental agreements, ASC partnerships – each should be looked at through an ROI lens. Real-world data remain a major untapped asset of each independent medical practice. The cost and burden of capturing those data are negligible. The returns are manifold and substantial.Contact us to learn more.