Transforming clinical trial data management through FHIR-based eSource

Authors: Kunal Dubey, Associate Director, Life Sciences & Vibhav Jain, Business Analyst, Life Sciences

Life sciences organizations have emerged from COVID-19 pandemic into a new environment for conducting Randomized Clinical Trials (RCTs). While the pandemic is not the only driver, it solidified five key industry trends accelerating the adoption of modern clinical data management methodologies and technologies.

Industry drivers: current state of clinical research data management

Sourcing clinical data is a primary operation in RCTs. These sources and how they are managed are changing fundamentally. Life sciences organizations and Contract Research Organizations (CROs) are looking to capitalize on these industry drivers and harness the technology key to streamlining clinical operations, workflows, and accelerating time-to-market.

Distributed sites of clinical data collection

Clinical research came to a grinding halt during the initial days of the pandemic until teams created virtual and distributed approaches to continuing their investigation. Those same tools have opened and increased the number of sites where research data are collected.

Greater number of clinical data sources

Data sources continue to increase beyond in-clinic, one-on-one collection via personal interactions. Today, data sources include mobile and smart devices and apps, patient-reported outcomes (PROs), direct electronic data entry, or EHR data transfer.

Need for a clear line of sight and auditability with validation

With new data sources and sites for data collection, it’s more critical than ever that researchers can trace, audit, and validate data easily and reliably.

Global offshore CRO outsourcing growth

More CROs are outside the U.S., and their use is increasing, particularly when labor costs are lower, patient populations are more readily available, and technology adoption is high.

Cost and speed pressures for greater efficiency

COVID-19 research, and vaccine development broke the mold for speed-to-market and set a new bar for life sciences organizations. These cost and speed pressures necessitate novel approaches to achieve greater efficiency, safety, efficacy, and cost controls.

Life sciences are shifting to interoperability and electronic data sources

Although most RCT data sources still rely on manual or paper capture and duplicative data entry efforts, life sciences organizations see the need to evolve with new technologies as the catalyst for the types of business, operational, and clinical value they seek.

Taking a holistic approach to data management that includes eSource, interoperability, and automation across the clinical value chain are the new tools for life science innovation and novel discoveries beyond the lab.

Integrated solutioning towards modern clinical trial data management

Optimizing eSource data

Electronic data sources (eSource) tap into digital information as part of the original documentation for a patient enrolled in a trial. eSource data is digitalized and captured at the point of research, eliminating duplicate entries, reducing errors, and saving time. Many industry leaders believe that eSource will become the primary mode of data collection.

Scenarios that include eSource data include:

  • A clinical investigator or trial team member could input patient data directly into an electronic data capture (EDC) system.
  • Trial participants may collect patient-reported outcomes (PROs) through a website, smart device, or mobile app.
  • Consulting specialists or trial reviewers can create electronic test reports directly in the electronic health record (EHR)
  • Remote monitoring or medical devices can capture patient data and transfer them directly into the EHR
  • Providers and ancillary medical staff may input data directly into the EHR
  • Laboratory reporting systems can automatically upload data into the EMR

Whether gathered from non-case report form sources, mobile devices, and apps, direct data entry, or via EHR data transfer, eSource moves data digitization closer to or at the point of collection. This is fundamental to realizing higher quality data that’s less laborious to collect and capture and less costly and accurate.

The value of FHIR® to modern clinical trial data management

Fast Healthcare Interoperability Resources (also known as FHIR) is an HL7 data standard that enables healthcare information exchange among stakeholders. Building a FHIR-based, electronically-source data management system for RCTs simplifies clinical trial implementation while expediting dataflow and preserving data integrity. Leveraging FHIR solutions facilitate communication, data sharing, and streamlined workflows, whether across the campus of a life science organization or distributed research sites globally.

Published studies highlight how FHIR and eSource data deliver greater value.

The first demonstrated how “data standards, workflows, and APIs can be used together to reduce implementation barriers while advancing the automation opportunities available for implementing FHIR-based eSource for clinical research.” The project used new extensions to the CDISC ODM and CDASH standards metadata, enabling retrieval and application of FHIR resource content that served several use cases for capturing eSource data and generating real-world evidence. [1]

A second study extracted data from medical records using FHIR, automating the process to populate electronic case report forms (eCRFs).  Clinical data were converted to the study data tabulation model (SDTM).  This research highlighted the value of the real-time availability of clinical data for analysis, providing clinical trial teams the ability to monitor data continually and identify trends in patient outcomes and safety. [2]

Benefits of using FHIR-based eSource data

Building an RCT using FHIR-based eSource data provides better quality, more traceable data sources faster, synergistically level up value throughout the RCT operations. When combined, these approaches can accelerate patient enrollment and site activation processes, reduce the overall clinical trial cycle time, and provide faster access to research data for more rapid decision-making.

Beyond data management: creating a modern clinical trial strategy

A modern clinical trial strategy includes technologies that extend a life sciences organization’s ability to conduct decentralized or virtual trials and remote patient recruitment and monitoring while extending reach globally and beyond the in-person visit. A FHIR-based eSource data management approach optimizes digitalization, interoperability, and automation to create a modern data management strategy.

As a global team that supports healthcare and life sciences organizations, CitiusTech offers sophisticated, proven technology solutions and experience of subject matter experts. Our dedicated team of industry professionals and clinical domain experts, coupled with our end-to-end data management capabilities, teams and tools, enables CROs and pharmaceutical companies to realize a modern clinical research strategy based on eSource, interoperability, and automation.


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