Medidata Study Published in JAMA Network Open Explores Growing Use of Linked Routine Data to Enhance Clinical Trial Insights

Medidata, a Dassault Systèmes brand and leading provider of clinical trial solutions to the life sciences industry, has published a first-of-its-kind study in JAMA Network Open. The research, covering the period from January 2016 to December 2023, sought to determine if clinical trials could be successfully linked with routinely collected healthcare data from sources including medical records and claims databases. The purpose was to identify existing trial linkage examples to demonstrate feasibility and provide deeper insights into treatment benefits, risks, and costs, empowering sponsors to make more informed decisions that ultimately enhance patient care and improve outcomes.

To conduct the study, researchers reviewed 990 abstracts from the National Institutes of Health PubMed database and MEDLINE, selecting 71 trials that used linkage to real-world data (RWD) to assess post-trial follow-up, capture trial outcomes, validate routinely collected data, and measure healthcare resource utilization and costs among other use cases. 

Linking clinical trial data with RWD sources opens new pathways to assess treatment impact beyond the trial, including healthcare resource utilization and long-term effectiveness and safety. This approach allows researchers to identify patient subgroups that benefit most from therapies and to understand lasting impact, leading to faster and smarter advances in medicine and delivering better health outcomes for patients worldwide.  

"While clinical trials offer robust data, they provide a limited view of the patient trajectories and outcomes," said Mehdi NajafZadeh, PhD, senior director, Evidence Generation Platform, Medidata. "Linking trial data with routinely collected  healthcare data offers a powerful solution to gain deeper, real-world insights and accelerate therapeutic advancements, as highlighted by our JAMA Network Open article."

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