Adopting a Data-Driven Approach to Optimize Clinical Trial Research

TriNetX is a global health research network, that brings together healthcare organizations, clinical research organizations and biopharmaceutical companies with a mission to enhance clinical trial design and accelerate study recruitment, to ultimately make new therapies available to patients faster. We spoke to David Fusari, Chief Technology Officer at TriNetX to learn more about their data-driven approach to clinical trial design and research, and the benefits of their cloud-based health research platform.

Laura Mason (LM): Could you tell me more about TriNetX and your company mission?

David Fusari (DF): TriNetX is the global health research network enabling healthcare organizations, biopharma, and contract research organizations (CROs) to collaborate, enhance trial design, accelerate recruitment, and bring new therapies to market faster. TriNetX combines electronic medical record (EMR) data such as demographics, diagnoses, procedures, medications, labs, along with genomics, deep oncology data and data derived from clinical documentation including discharge summaries, radiology reports, pathology reports, and others, to deliver the industry’s most comprehensive data set for cohort analysis and site selection.

LM: How does the TriNetX Network bring together Healthcare Organizations, Biopharma and Clinical Research Organizations?

DF: Network members utilize TriNetX’s cloud-based, health research platform to analyze patient populations and perform “what-if” analysis’ in real-time. As members, healthcare organizations receive hardware and software that are configured within the organization’s IT infrastructure and often builds on existing data resources such as Informatics for Integrating Biology and the Bedside (i2b2) and Observational Medical Outcomes Partnership (OMOP). Researchers then have access to the institution’s de-identified patient data through a user-friendly interface and a growing number of visualization and analysis capabilities. Biopharmaceutical companies and CROs are presented with aggregate views, but each data point in the TriNetX network can be traced to healthcare organizations who have the ability to identify individual patients, allowing clinical researchers to develop virtual patient cohorts that can then be re-identified for potential recruitment into a clinical trial.

LM: What are the benefits associated with successfully connecting these three industries?

DF: A huge obstacle in the time it takes to bring new therapies to patients in need, centers around amending a protocol. According to a recent Tufts study, 55% of amendments were caused by protocol design or lack of patient recruitment. Amendments can create a 3-month delay and cost upwards of $535,000. All too often, inclusion/exclusion (I/E) criteria is chosen without verifying the impact on the availability of a cohort and as a result, creates future avoidable amendments. Site selection is relationship-driven and susceptible to under enrollment, site failures, and identifying actual patients that match a protocol, which is usually manual and time-consuming. With TriNetX, researchers can design feasible protocols with self-service access to de-identified, EMR-sourced data, select sites with known patient counts that match the protocol, and the healthcare organizations can re-identify pre-qualified patients automatically and recruit them into the clinical trial.

LM: Awareness and utilization of cloud-based solutions is increasing. Could you tell us about the benefits of implementing a cloud-based health research platform?

DF: Cloud-based access means that research can be done in real-time, via a self-service model.  This improves efficiency and provides researchers with the ability to quickly perform “what-if” scenarios.

LM: I noticed that you have recently released several new announcements. Could you tell us more about these?

DF: We have recently released many exciting announcements:

• The TriNetX global health research network has grown to 68 healthcare organizations, 22 of the largest pharmaceutical companies and CROs all using the platform to improve protocol design, site selection, participant identification for clinical trial recruitment, and collaborative research across a range of therapeutic areas and development stages. We recently announced the addition of several healthcare organizations, including Boston Children’s Hospital, Weill Cornell Medicine, University of Iowa Health Care. In January, we announced that Sanofi has selected us as its digital partner.
  
  
• TriNetX now has toolkits to simplify the extraction of tumor registries and genomics data.  We now support both i2b2 and the OMOP common data model. We continue to innovate and bring new features and functionality to the platform to support our members’ research.  In February, we announced a chemotherapy lines of treatment identification algorithm that understands treatment patterns to deduce the line of chemotherapy treatment a patient is undergoing. This information, up to now nearly impossible to obtain, is critical for biopharmaceutical companies striving to develop therapies for patients involved in care regimens beyond first-line treatments.  
  
  
• We also now offer a Natural Language Processing (NLP) service, which utilizes sophisticated algorithms to extract clinical facts from physician notes and clinical reports, then links them with other EMR data, and makes the combined data available for pharmaceutical companies and CROs to instantaneously access, query and mine the data of real patients.
  
  
• The TriNetX platform has been used to analyze 5,941 protocols and 1,312 trials have been offered to healthcare organizations. Our recent announcement with University of Iowa Health Care, highlights how they were presented with 40 new clinical trial opportunities within the first 6 months of joining our network.