March 2023
TABLE OF CONTENTS
Introduction
Illustrative 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’s
Funding
Circles 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 Influence
Contact Us
Introduction
In principle, multicenter studies offer the opportunity for busy clinicians to collaborate across institutional and national boundaries in the development of statistically and clinically significant evidence. Many challenges, however, exist:
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Funding |
IRB’s |
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Identifying fellow clinicians willing and able to collaborate |
Clinical grade yet efficient IT platforms |
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Study design support |
Publication support |
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Scientific support |
Laboratory access, cost |
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Data rights |
Patient enrollment, compliance |
These challenges can be met economically, and with minimum burden. The design and execution of, and participation in, multicenter studies of any scale are well within reach of any clinician. This is due to several important trends in modern medicine:
- Consensus among regulators, payers, providers, industry and patients on the importance of real-world evidence.
- A variety of clinically efficient study formats supplemental or, in some cases, superior to, expensive RCT’s. For example – pragmatic, n of 1, quality improvement, observational, registries and others.
- Several of these study formats do not require IRB approval, yet can generate important correlations because of their large population sizes.
- For studies requiring such approval, most academic medical institutions have an approved list of commercial IRB’s.
- Modern software platforms combine the clinical-grade security and power of expensive EMR systems, with low cost, minimal burden and excellent user experience.
- The prevalence of Business Associate or similar agreements pursuant to which clinicians in institutional settings can work with approved third-party platform vendors.
Illustrative Multicenter Study Use Cases
The 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 Care
An 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 Making
A 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 Hypothesis
A 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.
Registries
A 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 Fellows
The 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’s
A 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.
Funding
Traditional 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.
Circles As A Comprehensive Solution
General
Circles 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 Approvals
As mentioned, many forms of clinically- and statistically significant studies do not require the involvement of an IRB. Examples are “observational” and “quality improvement” studies.
Data Collection, Aggregation, Correlations
The 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; and
- more.
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.
Patient Compliance And User Experience
Patient 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 Collaboration
For 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 Influence
Clinicians 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.
RegenMed works closely with Circle Members to develop the appropriate content, formats and distribution channels reflecting their work.
Conclusion
Most clinicians are capable of designing and/or participating in a multicenter study. Doing so need not be expensive or burdensome. Properly executed, such studies are professionally rewarding, and result in genuine clinical and professional value.
Contact Us
If you have any questions about how multicenter Circles may benefit you or your institution, please contact us.
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