For large registry trials or longitudinal studies lasting years or even decades, this limitation is particularly glaring. EDC systems don’t deliver automated eSource integration from external sources, such as electronic medical records (EMRs), connected health devices, or pharmacy benefits managers (PBMs), let alone with the various hospital systems used by the trial investigators who are actually conducting the research.
Many initiatives, including TransCelerate’s eSource Initiative and the Vulcan HL7 FHIR AcceleratorTM aim to accelerate the uptake of eSource integration throughout the industry. Ultimately, the solution is a unified data management system, a cloud-connected hub that ties in with every relevant system and stakeholder, and provides safe, secure data storage with access to anonymized data within and across projects and organizations – connecting, for example, the team advancing the science with providers seeking new views into their patients’ health. This type of database infrastructure fosters collaboration and provides a comprehensive view of patients’ treatment journeys to yield actionable data and valuable insights to improve outcomes.
Take for example a research project centered on pre-exposure prophylaxis (PrEP) treatment for HIV. The REDCap Cloud platform excels not only in carrying out the traditional functions of an EDC system – such as remote screening, consenting, enrolling, and conducting follow-up surveys – but it also seamlessly integrates crucial EMR data. This encompasses vital information such as appointment history, medication adherence, lab results, and patients’ CD4 cell counts (a critical measure of immunological health and HIV infection). Global hosting capabilities allow access to target populations in the most impacted regions, while multi-language features enable users to actively engage in the research process in real-time.
A unified data hub opens new avenues for personalized care and plays a crucial role in patient engagement before, during and after a clinical trial. The system can track clinical encounters, prescriptions refills, and gives care providers access to review and add to charts while connecting with community clinic therapists and other important stakeholders. From the patient’s perspective, their personal portal provides transparency, and virtual visits boost accessibility and engagement.
The REDCap Cloud unified data science platform goes beyond streamlined clinical workflows through process automation; it demonstrates remarkable scalability and the ability to seamlessly take control of complex data collection and management ecosystems. The platform provides an actionable database built for collaboration that is designed to connect people and systems within and across projects and organizations.
Here are key considerations for researchers when evaluating clinical trial data systems:
Prioritize collaboration beyond just patient to research team interactions and basic EDC. Opt for a solution that facilitates seamless sharing of data collection instruments with both internal colleagues and external collaborators. Ensure the database can manage diverse roles, multiple site-based workflows, and dynamic events.
Choose a platform that streamlines your organization’s research by replacing disparate systems with a secure, scalable, and widely adopted cloud-based infrastructure. This promotes collaboration, standardization, and efficient process tracking. Ensure seamless integration with essential systems like EMRs, lab systems, connected health devices, PBMs, and more to gain a comprehensive view of patients’ treatment journeys.
Dynamic events, automated reports, and real-time alerts should be integral components of any data system under consideration.
Choose a versatile system that serves both non-profit and academic settings, while also accommodating Investigator Initiated Research (IIR). It’s equally essential that the system is well-established in the commercial research industry. By embracing a unified system across these diverse sectors, you will be better positioned to contribute to the larger mission of bridging the gap between academic, translational, life science, and commercial research industries. This harmonization fosters collaboration throughout the entire research lifecycle, from initial discovery to real-world application, amplifying efficiency and nurturing a holistic approach to research endeavors.