Designing Correlatable Clinical Evidence

RE.GA.IN’s RMCE was founded upon clinical evidence. Using our inCytes platform, they capture unique clinical data sets against every patient treated, leveraging such data to standardize their approaches and outcomes. This Case Study introduces the team, process and results in setting up their initial library of unique Observational Protocols. Such protocols are custom designed to capture the right data against their varied offering of regenerative treatments, human cell/tissue products and over 15+ MSK pathologies.

We began by forming a dynamically experienced scientific committee comprised of Diego Correa, Severiano Dos Anjos, and Laura de Girolamo. The committee determined that a specific Observational Protocol, or set of clinical queries, would need to be developed against any pathology. With over 15 MSK pathologies currently being treated, it seemed like a tall order. However, it was determined that those Observational Protocols could share a number of clinical data points, simultaneously lowering the burden of data design while increasing the correlations that could be made across different pathologies and treatments.  For example, queries relating to the characterization of tissues could be applicable to all pathologies, while outcomes would need to be measured with pathology-specific PROs.  

Next, we had to organize those clinical queries into surveys. We abided by the rule that each survey should be short,  completed in one sitting, and  tailored to a specific audience, whether clinician, patient, scientist or other. This would help ensure the observations were recorded, no matter the recipient, in a compliant, verifiable manner.  These surveys would be assigned to the right audience at the right time, effectively delegating the work across a broad number of participants. RE.GA.IN was able to exploit one key advantage when it developed a tissue characterization survey, and delegated its completion to their internal laboratory and staff.  

Finally, with the over-arching Observational Protocol structure in place, the committee approached each pathology, treatment protocol, and tissue type, designing the queries, responses, and surveys best suited to capture and correlate their unique clinical evidence. As they worked, they frequently balanced the desire for more data with expected clinical realities. Their work resulted in over 19 treatment paths as of the date of this note, and several rounds of revisions based on real world experience. This process, combined with inCytes, has enabled them to apply tailored observational protocols to their diverse patient lists.

If you wish to learn more about RE.GA.IN, its Treatment Paths, or its evidence collected to date, contact us.