Ken Dec, Chief Marketing Officer, mTuitive
Clinical trials are the backbone of biopharma innovation. Yet, as McKinsey’s recent analysis highlights, the industry faces a major bottleneck: patient recruitment. Despite historic investment in R&D and a growing pipeline of novel therapies, as many as 80% of clinical trials fail to finish on time, often because sponsors can’t find and enroll the right participants quickly enough.
At mTuitive, we believe structured data is one of the most underutilized levers available to biopharma sponsors, clinical sites, and investigators to overcome these recruitment hurdles. By turning unstructured patient information into computable, standardized data, structured reporting systems can make trials more efficient, equitable, and patient-centric.
1. Pinpointing Eligible Patients Faster
Recruitment challenges are often tied to eligibility criteria that require precise clinical details: tumor stage, biomarker expression, prior treatment history, comorbidities. In many health systems, these data points exist, but are buried in narrative pathology reports, physician notes, or siloed systems.
Structured data changes that. With synoptic reporting, each critical data element is captured in a standardized field that can be queried instantly. Instead of manually sifting through thousands of records, sponsors and sites can rapidly identify patients who meet highly specific criteria, cutting recruitment timelines dramatically.
2. Expanding Beyond Major Academic Centers
Today, only about 6% of cancer patients in the U.S. enroll in clinical trials, with participation heavily concentrated at National Cancer Institute centers. Community hospitals and regional health systems, where the majority of patients actually receive care, often lack the infrastructure to match patients to trials.
Structured data lowers that barrier. When pathology and surgical data are standardized, community sites can generate trial-ready patient cohorts with the same level of precision as major centers. This not only expands access to research for underserved populations but also broadens the recruitment pool for sponsors struggling to meet enrollment targets.
3. Supporting Precision Medicine at Scale
More than half of oncology trials today target biomarker-defined subpopulations. While this is a triumph for personalized medicine, it makes recruitment harder: sites may only have a handful, or zero, eligible patients for a given protocol.
With structured data, eligibility attributes like HER2 status, KRAS mutations, or PD-L1 expression are no longer buried in scanned reports. They can be aggregated across networks, shared securely with trial-matching platforms, and used to build multi-site recruitment pipelines for narrow trial cohorts. This accelerates enrollment for precision medicine studies without overburdening any single site.
4. Reducing Burden on Sites and Investigators
Clinical trial site staff are stretched thin, facing rising demands from complex protocols and turnover among PIs and coordinators. Manual chart review for eligibility screening adds to that burden.
By embedding structured reporting into routine clinical workflows, trial-critical data are captured once, at the point of care, and then reused for eligibility screening, regulatory reporting, and trial enrollment. This reduces redundant work, minimizes errors, and improves the investigator experience, positioning sponsors as “partners of choice.”
5. Enabling Smarter Site Selection
Sponsors increasingly use AI-driven models to select trial sites. But those models are only as good as the data fed into them. Structured pathology and surgical data provide a clear, reliable picture of patient volumes, subpopulation sizes, and historical case mixes at each site.
This allows sponsors to select sites with higher precision, anticipate recruitment bottlenecks earlier, and provide targeted support where needed, improving overall trial performance.
Conclusion: Structured Data as a Recruitment Accelerator
Clinical trial recruitment is one of the greatest challenges facing the biopharma industry today. While innovative trial designs, hybrid delivery models, and better site engagement will all play important roles, structured data is the connective tissue that enables each of these strategies to succeed.
At mTuitive, we’ve seen firsthand how synoptic reporting empowers providers, sponsors, and patients by turning clinical details into computable, shareable insights. By embracing structured data, the industry can accelerate recruitment, reduce trial delays, and bring life-changing therapies to patients faster.
mTuitive is revolutionizing reporting, data, and analytical software for digital pathology and surgical oncology. Their innovative synoptic reporting software allows for the aggregation of a patient's data with thousands of different reports, giving medical professionals new insights and understanding to elevate the standard of care and benefit the patient. By capturing all required data and ensuring standards compliance, hospitals and surgery centers can improve efficiency and accuracy. With a commitment to continued innovation, mTuitive is at the forefront of shaping the future of medicine, enabling the best minds in healthcare to make better decisions and provide the best possible outcomes for patients. Learn more at www.mtuitive.com.
