TherapyMonitor Reports Offer Regulatory-Grade Insights Built Upon European Longitudinal and Representative Patient-Level Real-World Data
Cambridge, MA, April 12, 2023 — TriNetX, through its wholly owned subsidiary TriNetX Oncology GmbH, announces the availability of the European Multiple Myeloma (MM) Real-World Evidence (RWE) TherapyMonitor Report. The report focuses on longitudinal individualized treatment algorithms including chimeric antigen receptor (CAR) T-cell and B-cell maturation antigen (BCMA), and best achieved outcomes by line in patients with MM disease from the initial diagnosis up to tenth line therapies and beyond.
This is the latest in a series of TherapyMonitor Reports developed by TriNetX Oncology. The company was previously known as OncologyInformationService e.K. (OIS), the European regulatory-grade real-world evidence (RWE) leader acquired by TriNetX, LLC in October 2022.
“The insights revealed by TherapyMonitor are beneficial for pharmaceutical leaders seeking to better understand and fulfill unmet patient needs in drug development, especially from the European perspective,” said Sébastien Wischlen, Vice President Oncology, TriNetX Oncology GmbH, and Managing Director, CancerDataNet, GmbH. “For example, we observed a significant decrease in newly diagnosed multiple myeloma (NDMM) incidence at the beginning of the COVID-19 pandemic, as well as a rapid decrease at the second COVID-19 wave in Germany. This has ultimately led to changes in the characteristics and prognoses for many of these patients.”
Each TherapyMonitor Report provides critical insights to support all stages of the pharmaceutical value chain, from developing the most effective protocol in the clinical development phase, especially if an external real-world control arm is requested, demonstrating need in the pre-launch phase, establishing differentiation in the post-launch phase, to uncovering longitudinal sequential treatment patterns, utilization rates, and safety in the lifecycle management phase across the EU.
“The TherapyMonitor methodology entails the collection of thousands of variables per patient along their treatment journey, tracing back to the initial diagnosis,” said Lenka Kellerman, Senior Vice President Oncology, TriNetX Oncology GmbH. “TriNetX Oncology GmbH collaborates with renowned medical experts and pharmaceutical leaders to generate fit-for-purpose databases sourced from a representative sample of patients and institutions with stringent quality management processes suitable for use with regulators such as the Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) and Gemeinsamer Bundesausschuss (G-BA).”
TherapyMonitor Reports contain anonymous data derived from regulatory-grade, longitudinal, indication-specific, and highly curated patient-level data, including:
- Comprehensive individual patient demographics and disease characteristics
- Highly granular diagnostics and cytogenetics data, therapy and drug-specific data including timestamps for all therapy events including modifications
- Detailed information on outcomes for each treatment line, assessment method and progression or relapse definition according to clinical guidelines and caregiver definition
- Institutional characteristics and patient clinical pathway
Additional TherapyMonitor Reports in hematological malignancies are also available in Europe including Chronic Lymphocytic Leukemia (CLL), Diffuse Large B Cell Lymphoma (DLBCL), and Myelofibrosis.
To obtain a sample MM report or to learn more about TherapyMonitor Reports for other indications, please visit trinetx.com/tnxogmbh or email email@example.com.
About TriNetX, LLC
TriNetX is a global network of healthcare organizations and life sciences companies driving real-world research to accelerate the development of new therapies. Through its self-service, HIPAA, GDPR, and LGPD-compliant platform of federated EHR, datasets, and consulting partnerships, TriNetX puts the power of real-world data into the hands of its worldwide community to improve protocol design, streamline trial operations, refine safety signals, and enrich real-world evidence generation. For more information, visit TriNetX at www.trinetx.com or follow @TriNetX on Twitter.