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The Clinical Trials Industry’s Weekly News Update

Decentralized tech speeds enrolment, say researchers

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Decentralization offers the clinical trials industry disruption proof recruitment according to research which indicates that techniques adopted during the pandemic boost participation and engagement.

The study – available here – looked at a trial of oral anticoagulant therapy sponsored by Stanford University in which atrial fibrillation (AF) patients enrolled and participated virtually using a mobile application and remote blood pressure (BP) and six-lead electrocardiogram (ECG) sensors.

According to the analysis 100 subjects signed up to take part in the research within 28 days. It also revealed that ECG and BP measurement completion rates were both 99% with engagement rates – taking part in tele-visits and surveys – being 91% and 85%, respectively.

The results seen in the Stanford study suggest decentralized tools can have a significant impact on both patient recruitment and engagement according to the authors, who said the approach has wider application.

“The study demonstrated rapid recruitment, high engagement, and physiologic reporting via the integration of digital technologies and dedicated study coordination. These findings may inform DCT designs for future cardiovascular trials.”

They added that “Our findings point to the potentially beneficial role of virtual recruitment, as we observed a dramatic surge in enrollment upon transitioning from traditional in-person recruitment to a social media-based virtual strategy.

“At completion, the study had a waitlist population of eligible participants that was more than twice our target enrollment. The speed and geographic reach of virtual recruitment—along with the ability to refine advertisement formatting and targeting to achieve maximal views—may have helped achieve timely recruitment.”

The findings are in keeping with the mHealth Screening to Prevent Strokes (mSToPS) trial, the Apple Heart Study, the Fitbit Heart Study, and the Mobile Health [mHealth] Technology for Improved Screening, Patient Involvement and Optimizing Integrated Care in Atrial Fibrillation (MAFA II) study.

“These key studies leveraged remote procedures and achieved large-scale (thousands of patients) recruitment and conduct, including a self-applied continuous ECG monitoring patch in the mSToPS trial, and wearable devices in the Apple Heart Study, the Fitbit Heart Study, and the MAFA II study,” the authors said.

Image: Stock Photo Secrets

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