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Statistical Significance and Clinical Relevance are two important concepts in the field of medicine, and particularly in clinical research.Being a bit more specific, statistical significance refers to the likelihood that a result is not due to chance. In other words, it is the probability that an observed effect (for example, a clinical effect resulting from a given treatment) is real and not just due to chance. A statistically significant result is considered meaningful in general terms when the p-value is less than 0.05, meaning that there is less than a 5% chance that the observed effect is due to chance.Clinical relevance refers to the practical importance of any effect (after a treatment) on a patient’s everyday life (i.e. less pain, higher survival rate or better quality of life). Any result can be considered clinically relevant when it has a meaningful impact on patient outcomes, for example using a patient reported outcome measure (PROM).These two concepts are related but not equivalent. For many reasons, a given result may be statistically significant but not clinically relevant, or vice versa. For example, a treatment may have a large clinical effect but fail to reach statistically significance due to a small population size or other factors, such as data dispersion or variability.‍In summary, statistical significance and clinical relevance are both important for clinical research, the first providing unbiased evidence of a relationship or effect, while the latter represents the practical implications of results obtained in terms of patient care and decision making.The ideal situation is having a result that is both statistically significant and clinically relevant. One of the best ways to achieve this in clinical trials, is deriving research data from a large number of a homogeneous group of enrolled patients (restricted by inclusion and exclusion criteria). However, in a real world scenario there is high variability and many factors affecting any clinical outcome (disease severity, age, sex, comorbidities, etc).There is also one more aspect that affects clinical relevance for any real patient population, and is called generalizability, the degree to which you can apply the results of any clinical study to a broader patient population. One good example is that many clinical trials might offer statistical significance and clinical relevance in a restricted study population, but not generalizability.The use of Real-World Data obtained from daily clinical practice could overcome the previous limitations by allowing clinicians to easily collaborate and aggregate de-identified data. This could lead to the generation of Real-World Evidence that can be considered statistically significant, clinically relevant and generalizable to different patient populations.RegenMed Circles have been developed with this goal in mind, facilitating data sharing among healthcare practitioners and their industry partners, and putting the patient at the center of their care to advance and progress in any field of medicine and healthcare.If you want to know more about Circles or how our solutions could help you in different ways, contact us.

Real-world evidence (RWE) is valuable not only for regulatory compliance, clinical decision-making and tracking adverse events. It can also drive patient engagement, profitability and professional advancement.The highest quality RWE reflects scientific rigor, long-term outcomes capture and statistical significance. For many, these parameters suggest expense and clinical burden. This need not be the case, especially in the context of Circles. An interesting use case for the efficient development of RWE, and subsequent value creation, is the recent work done by BioXcellerator (Biox) in Colombia.Biox treats patients from throughout North America, often coordinating with physicians in the U.S. and other countries. In 2022, Biox developed an observational study protocol comprising key pre-, peri- and post clinical datapoints. Outcomes are measured utilizing the Impairment Scale for traumatic spinal cord injury developed by the American Spinal Injury Association. Patients are also assessed using the Barthel Index For Activities of Daily Living.Biox has now collected real-world data against their protocol for more than 380 cases. Its preliminary reports and analysis are summarized in the charts below. These are already providing value to treating physicians, referring physicians, existing patients as well as those considering therapeutic alternatives for spinal indications.Moreover, such real-world observational studies are now standard for BIOX physicians and their patients. This will result in transparent evidence-based standards of care specific to a variety of indications and patient-cohorts.Although this use case involves biologics for degenerative spine disease, systematic collection and analysis of real-world evidence are valuable in the context of any indication or clinical setting. The generation by practitioners in any specialty of scientifically valid real-world evidence need not be burdensome or expensive. Moreover, it adds substantial benefits not only in clinical decision support, but practice growth, professional advancement, collaboration, product improvement and influence among peers.Contact us to find out more.

Evidence-based solutions for professional and financial advancement.You have the Cases, and RegenMed has time, tools and expertise toextract their true value. If you’ll share your objectives, we will present a turnkey, burden-free solution comprising one or more of: Study Design Patient-Reported Outcomes Patient Engagement Electronic Data Capture Peer-to-Peer Collaboration Social Media Management Ethical Industry Intermediation Compliance IRB’s and Ethics Committees Contact us to learn more.

Private, evidence-based social communities for clinical customers. Peer-to-peer communications are the most powerful form of marketing. However, recruiting opinion leaders and engaging busy practitioners are expensive and increasingly fraught with legal and policy complexities. As a result, the return on investment from medical conference sponsorship, large detailing forces, sponsored trials and studies and other direct-to-physician programs is increasingly unclear.Compare Circle Academies, where focused and exclusive social communities support sustained collaboration among healthcare professionals and researchers in the context of any clinical theme. That collaboration and resulting peer-to-peer communications are driven by: Real-world evidence deriving from Academy Members’ own busy clinical practicesThe design, validation and ongoing expansion of treatment protocols, patient education materials, new product indicationsThe continual and moderated exchange among peers of posts, questions, threaded comments, best practices, multimedia presentations, education and trainingAccess to relevant, and only relevant, product communicationsCharacteristics of Each Circle AcademyBuilt around a major clinical themeRegular content submission by thought leadersMulti-lingualCan be white-labelled, setup in a matter of daysIndustry Corner, allowing communications to, interaction with, highly engaged MembersContent comprises video, multimedia presentations, posts, threaded comments, otherMembership limited to credentialed healthcare practitionersAll the power, convenience and functionality of modern social media platformsContinual moderation to drive sustained recruitment of and interaction among MembersAutomatic integration with Circles, inCytes™ and Benchmarc™ allowing efficient collaboration among Members within and across institutions and countriesContent focuses on real-world evidence – collection, aggregation, clinically impactful correlationsBenefits for IndustryLow-cost, efficient and turnkey solution for all data-related objectives, including:Studies and trials. Formal or informal. Single or multicenter. Pragmatic.“n=1”. “Hybrid”IND, IDE, PMA, postmarket surveillance and other regulatory submissions IRB and medical ethics committee submissionsRegistriesInvestigator recruitment, patient recruitmentTraining and educationTargeted social media listening and communicationsContact us to learn more.

Benchmarc™ provides instant access to patients' own health data, allowing them to see and understand the progress they have made. With this information, patients are able to have deeper conversations with their physician, such as discussing key milestones or manage a personalized recovery plan.To learn more, please see check out our downloadable Benchmarc™ Brochure.