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.

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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.

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