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CTTI Collaborates with Multiple U.S. Organizations on First Successful Embedded Trial Using National Health Plans’ Data

Today, at the ESC Congress 2020 – The Digital Experience, a group of U.S. investigators from several organizations including CTTI announced their collaborative findings from the Implementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AFib) trial.


CTTI worked with Aetna, Duke Clinical Research Institute, the Harvard Pilgrim Health Care Institute's Department of Population Medicine, Harvard Pilgrim Health Care, HealthCore Anthem, Humana, Optum, and the FDA, as well as a patient representative, to plan and conduct this ground-breaking, 80,000-patient, randomized clinical study. This trial was the first ever to leverage the FDA-Catalyst System network of electronic health data, which consolidates data from a diverse group of national health plan data partners.


The study involved identifying patients with atrial fibrillation (AF) who were at high risk of stroke and not currently taking any type of oral anticoagulant (OAC). The goal of the study was to learn if mailing educational information to patients and their providers could incentivize patients to initiate important OAC prescribing discussions with their doctors.


“It is imperative to identify all patients with AF who are at risk of stroke, especially because strokes can be prevented with OAC,” said Sean Pokorney, co-principal investigator at Duke Clinical Research Institute, who presented the findings at the event. “The underuse of OAC is a significant public health priority, and also a priority of health plans like those participating in this study, which is why we were so eager to collaborate on IMPACT-AFib.”


Although it had never been done before, the study relied upon administrative health plan data and pharmacy dispensing data from multiple national health plans to identify eligible patients and randomize them to an early or delayed intervention, and to assess clinical outcomes.


The study results showed that it would take more than one educational mailing to achieve the desired outcome. Moreover, the study sets a foundation for future clinical trials in AF and other diseases as an example of how the FDA-Catalyst System can help to conduct trials using new and resourceful methods. The goal is for solutions like this to help clinical trial stakeholders conduct future trials much faster than before.


“CTTI played a key role in the pre-work for this trial, proving the viability of running a large-scale trial using the FDA-Catalyst platform,” added Pamela Tenaerts, executive director at CTTI. “The study is a successful proof of concept of embedding a randomized clinical trial into a claims system, while confirming in a large scale experiment that the use of educational interventional approaches in medicine might be limited. We believe that all future clinical trials should maximally leverage available clinical and nonclinical data to minimize collection of necessary trial specific data, and the IMPACT-AFib trial is a fantastic example of that; it serves as a strong model for future research.”


Read the full press release.