Post-marketing approval studies in clinical research for cancer typically suffer from poor engagement and protracted timelines – driving up costs and delaying critical evidence generation. In oncology post-marketing trials, patients receiving care from community facilities are also often under-represented, with such sites also facing heightened challenges with recruitment.
Community oncology centers can face difficulties in terms of both resources and budgets compared with academic centers. As a result, it is often a challenge for community sites to take part in studies, especially post-marketing research. Consequently, patients can miss out on essential treatments that not only benefit their condition but also widen the understanding of therapeutic options.
Electronic health records (EHRs) into electronic data capture (EDC) platforms are starting to make a major difference and close the accessibility gap in this area of research. Alongside this, automated workflows can dramatically improve patient recruitment and retention in community studies, as well as reduce unconscious bias and increase representation across different ethnic groups and demographics.
A pilot project demonstrated how technology solutions and streamlined processes can make a dramatic difference to post-marketing oncology studies in community settings. The research paper recently published in NPJ Health Systems, titled Feasibility Assessment of an EHR-Integrated Research Platform for Prospective Data Collection in Community Oncology Practice1, revealed how an integrated digital solution can drive efficiencies and streamline workflows in such locations.
Addressing data management solutions in post-marketing oncology studies
The pilot project was sponsored by a multinational pharma company, which was recruiting for a post-marketing approval oncology study. Running at four independent community-based oncology centers in the US from April 2024 to March 2025, the pilot project also had a 15% diversity target for enrollment.
Given the lack of resources often at oncology community centers, Flatiron Health’s Clinical Pipe connector was leveraged in the pilot study to enable secure EHR-to-EDC data transfer and reduce the need for manual transcription.
“There is a persistent disparity in clinical research access, as community sites are rarely afforded the same trial opportunities as academic medical centers,” explains Amanda Rodriguez-Sullivan, Head of Clinical Operations at Paradigm Health, who was involved with the pilot study and a credited author of the Nature article. Flatiron Health’s Clinical Research division was acquired by Paradigm Health in December 2025.
To make the pilot study as pragmatic as possible, there was an emphasis on protocol optimization, with a focus on critical to quality data supporting endpoints and key operational metrics. The ultimate purpose for the Flatiron team was to prove that the technology streamlines, while enabling end-to-end data flow, and reducing the burden on community sites as much as possible.
When planning the pilot, the team mapped all critical data and its source (e.g. structured EHR data, unstructured data in notes and reports) with the aim of reducing cleaning, querying, and monitoring burden for individual site teams.
Centralizing operations allowed sites to add more studies under a simple scope of work. Full training was provided for the EHR-to-EDC connector before any data entry or enrollment of participants.
In addition to technology enablement, the study offered centralized operations to reduce the operational burden. Centralized operations included contracting and feasibility, as well as collaborations with vendors that enabled automated payments.
Streamlined data collection in oncology trials
The pilot study focused on collecting data used to analyze how patients with multiple myeloma reacted to treatment from daratumumab – a type of monoclonal antibody that binds to the CD38 protein.
Screening covered 353,602 individuals through a combination of human review and matching performed by automation. From this, 287 were identified as eligible for the trial with target enrollment of 70 participants.
In the 11-month pilot study, the Paradigm Health solution enabled recruitment 6.5 times faster than traditional post-marketing studies, with enrollment costs 20%-30% lower. In addition, the enrollment target was exceeded. Furthermore, 91% of the study data was captured directly from the EHR.
The rapid recruitment phase was attributed to the centralized technology-enabled identification of patients. Another crucial result was that Black or Hispanic patients made up 30.5% of those enrolled – more than double the target. This percentage was also far higher than in typical myeloma studies, where both groups are often underrepresented2.
The data-driven future of clinical trials
Through the pilot study, the bespoke EHR-integrated platforms were found to be a highly effective solution for community oncology teams. The study demonstrated that the platform for tech-enhanced execution of pragmatically designed trials vastly improves the efficiency of trial conduct. Community sites can gain efficiencies from this platform.
The Paradigm Health-owned platform used in the pilot study showed that high-quality data could be captured from community locations. In addition, the study confirmed that pragmatic study designs and automated data capture are essential for the future of accelerating and streamlining clinical trials.
Paradigm Health is now applying its findings to two new studies, with others potentially in the pipeline. One study underway is a biospecimen collection study that involves 1,350 patients across over 40 sites – demonstrating what is possible with Paradigm Health solutions.
With the FDA now exploring new methods for high-quality data capture in clinical research and submission in regulatory applications, advances made by Paradigm Health could deliver significant benefits.
Paradigm Health offers a comprehensive end-to-end platform for clinical trials that covers everything from initial trial planning and design to recruitment, trial execution, and post-marketing monitoring. Paradigm Health’s Clinical Trial Network includes more than 1,100 specialists across approximately 2,100 locations, and upwards of 800 research sites. The company aims to use its technology to drive smarter clinical trials that streamline data collection and management at scale, while reducing the burden on sponsors, sites, and participants, with scientific rigor maintained throughout.
To learn more about the solutions provided by Paradigm Health in making clinical trials more sustainable, download the document below.
References:
- https://www.nature.com/articles/s44401-025-00066-9
- https://ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e13709
