Site disengagement can be a major barrier to successful and timely trial execution. A significant contributor to disengagement is overloading sites with redundant processes and technologies that are not cross-compatible. Accordingly, careful consideration of systems and tools can enhance site adoption and subsequent engagement.
Sponsors should seek out vendors that prioritize interoperability, ensuring that platforms integrate smoothly with technologies sites are already using, such as electronic health records (EHRs) and electronic patient-reported outcomes (ePRO) platforms. Systems that operate in silos can increase duplication, risk, and resistance to adoption. In this blog, we cover different strategies for enhancing interoperability and smooth integration of systems.
One of the most impactful ways sponsors can reduce site burden is by enabling seamless integration with EHRs. EHRs are digital systems used by healthcare providers to store and manage patient information, including demographics, clinical notes, lab results, and treatment histories. Over the past few years, they have been used extensively in research and to generate large databases across therapeutic areas and diseases. There has been a parallel move in the clinical setting to use EHRs as a standardized study platform. A systematic review revealed that EHR data has successfully been leveraged across multiple trial functions, including participant identification, recruitment, data collection, and outcome analysis. By tapping into existing EHR infrastructure, sponsors can enable real-time access to clinical data, reduce reliance on manual data entry, and significantly improve data accuracy and completeness.
A compelling example of EHR integration in action came during the COVID-19 pandemic, when a large-scale clinical research project was embedded directly into a commercial EHR system at a major healthcare institution. By aligning the study with existing clinical workflows for testing and vaccination, and using the EHR for participant enrollment and data capture, the research team was able to recruit rapidly and at low cost. This approach minimized disruption to clinical staff and demonstrated how leveraging existing digital infrastructure can support efficient, scalable trials without overburdening sites.
ePRO platforms allow patients to report on their symptoms, quality of life, or treatment experiences directly, typically through digital surveys. These tools provide valuable insights into the patient experience and are increasingly used in trials to support real-world, longitudinal data collection. ePRO platforms can therefore play a critical role in reducing site and patient burden while capturing rich data. When integrated with existing systems like EHRs, ePRO tools can further automate data flow, eliminating the need for redundant entry and improving both accuracy and efficiency.
A recent randomized clinical trial in Japan demonstrated the impact of a site- and patient-friendly ePRO system. Patients completed disease-specific questionnaires on tablets before their appointments, and the data was reviewed by physicians in real time. The results showed significant improvements in patient satisfaction, communication, and understanding of treatment plans. For sponsors, choosing interoperable ePRO platforms that align with site infrastructure is key to encouraging adoption and improving trial outcomes.
Integration across systems minimizes redundancy, thereby reducing site resistance and fostering stronger engagement. When sponsors choose vendors and platforms that enhance interoperability and efficiency, they position their studies to benefit from higher adoption rates, improved data quality, and smoother execution.
For more practical strategies on supporting research sites and improving trial execution, download our full guide on empowering site engagement.