In the dynamic world of healthcare, real-world data (RWD) and the real-world evidence (RWE) derived from it stand as a crucial pillar for informed insights and actions. No where is this more evident than in oncology, where RWD and RWE are delivering on four key areas:
- Driving more inclusive healthcare research.
- Speeding up innovation and new therapies into the market.
- Improving patient outcomes.
- Enabling healthcare organizations (HCOs) to deliver higher-quality, cost-effective care.
The team at TriNetX Oncology brings a unique approach to the world of RWD and RWE in oncology research and patient care. Rather than amassing a large volume of patient data, TriNetX Oncology dives deep into patient-specific information, providing valuable insights into the patient flow, treatment paths, and overall healthcare landscape.
This “microscope” and “satellite” approach allows for a balance of granular details and broader population-level perspectives across various oncology indications, with additional work extending to hematology and rare diseases.
Emphasizing Detailed Patient Journeys and Holistic Data Collection to Answer Complex Research Questions
Working primarily with pharmaceutical companies that require precise answers to complex questions that can only be addressed through RWE, TriNetX Oncology sources anonymized, curated data from treating physicians to fuel their custom projects. This approach leverages a close network of healthcare organizations (HCOs) and physicians, who act as collaborators in data collection, allowing the team to offer representative patient samples from diverse treatment settings.
This level of involvement by HCOs not only ensures high-quality data but also aligns with the healthcare landscape in each region. For instance, in Germany, where most patients are treated in community practices, TriNetX Oncology focuses on collecting data representative of these institutions to ensure a true-to-life perspective of patient experiences.
TherapyMonitor™: Oncology Research Powered with Real-Time Data Insights
TherapyMonitor™, a custom-built registry that supports longitudinal data collection across a collaborative research network, provides current, representative insights into treatment trends and patient outcomes.
Once collected, the data undergoes extensive analysis tailored to the research questions of the sponsors. Analytical techniques include descriptive statistics, multivariate analysis, and predictive modeling. Additionally, TherapyMonitor™ allows for a dynamic analysis of patient journeys through Sankey diagrams, tracking treatment flows and changes over time. This ability to visualize patient pathways offers valuable insights into treatment sequencing and decision-making.
A notable example of the TherapyMonitor’s application is the multiple myeloma registry, which began in Germany in 2016 and has expanded to include Spain, with additional countries in discussion. This registry has become a powerful tool for answering various research questions, from understanding treatment pathways to supporting regulatory submissions.
Regulatory and Clinical Implications
TherapyMonitor’s data is of regulatory-grade quality, meeting the stringent requirements of entities such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and national Health Technology Assessment (HTA) bodies. In Germany, for instance, TriNetX Oncology’s data supports submissions to the Gemeinsamer Bundesausschuss (GBA) for drug pricing and reimbursement decisions.
TherapyMonitor™ data can be used for external control arms (ECAs) in single-arm clinical trials. The longitudinal nature of these registries enables TriNetX Oncology to track patient outcomes over time and provide insights into the evolving treatment landscape, even as new therapies and technologies, like CAR-T, emerge. In the case of CAR-T therapy for multiple myeloma, TherapyMonitor™ was used to facilitate comparative studies, where a comparator arm was constructed using registry data to assess the risk-benefit profile of the therapy.
TherapyMonitor’s adherence to the General Data Protection Regulation (GDPR) ensures data privacy, with anonymization conducted at the physician level. This compliance allows TriNetX Oncology to handle sensitive data while maintaining patient confidentiality. Moreover, TherapyMonitor’s capacity to perform multiple analyses with a single dataset addresses the evolving needs of pan-European HTA regulations, such as the Joint Clinical Assessment, which demands representative, high-quality data for cross-national submissions.
Deep Oncology Insights Through a Unique RWD Methodology
TriNetX Oncology offers a distinctive RWD approach that combines depth, representativeness, and longitudinal tracking to support a range of research and regulatory objectives in oncology. By partnering closely with healthcare providers and utilizing TherapyMonitor™ as a flexible, high-quality data source, TriNetX Oncology enables pharmaceutical companies and researchers to gain a comprehensive understanding of patient journeys and treatment trends across various indications.
This unique approach not only facilitates scientific discovery and publication but also plays a vital role in regulatory submissions and real-world treatment insights. With its deep oncology focus, TriNetX Oncology continues to evolve as a valuable resource for meaningful, real-world insights that shape the future of oncology research.
Learn more about TriNetX Oncology, download a TherapyMonitor™ sample, and see how our non-U.S. oncology RWD services can help your organization accelerate clinical research and advance patient care.
About Markus Rückert, PhD
Markus is a seasoned biopharmaceutical expert specializing in oncology and rare diseases. Proficient in clinical development and Medical Affairs, as well as experimental and RWE generation, Markus has successfully navigated various stages of drug development — from discovery to market launch — with a keen focus on advancing oncological and rare disease therapies for tangible patient benefits. Having achieved significant milestones in oncology and rare disease therapeutics, Markus now channels his diverse expertise towards broader pursuits in epidemiology, health service research, and the real-world impact of oncological treatments.
