Medhealth Review

The imminent evolution of decentralization within the landscape of clinical trials

The landscape of clinical research is undergoing a transformation. Rather than bringing patients to sites, the approach now involves bringing the trials to patients through direct-to-patient drug shipments, home nursing, video conferencing, and electronic data collection. This shift enhances the patient experience by eliminating the need for extensive travel. Daniel Tanner, Chief Commercial Officer at Cerba Research, highlights the benefits of this patient-centric approach. He notes that traditional clinical trials often faced challenges in terms of efficiency, costs, and diversity. Limited participation rates and a lack of participant diversity have been persistent issues. Decentralized trials (DCTs) could alleviate these concerns, particularly by improving participation rates and diversity.

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Research indicates that DCTs have reduced trial timelines and yielded significant financial benefits. Despite the evident advantages, widespread adoption faces obstacles. Tanner acknowledges the pharmaceutical industry’s cautious approach due to regulatory pressures and concerns about patient safety and data integrity. However, the COVID-19 pandemic accelerated the adoption of decentralized approaches, pushing the industry to embrace change rapidly.

Moving forward, transitioning to DCTs requires overcoming various challenges, including change management, regulatory complexities across different regions, logistical hurdles in drug shipment and blood draws, and ensuring compliance and patient safety in a decentralized setting.

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Cerba Research utilizes its network of laboratories to support hybrid DCTs, enabling patients to have their blood drawn by medical professionals without travelling to trial sites. Additionally, innovations like dried blood spot testing and patient-focused recruitment strategies in routine diagnostic labs enhance patient access to trials.

Looking ahead, Tanner emphasizes the importance of incorporating the patient perspective into study designs and adopting a longitudinal approach to clinical research. He believes that the industry should strive to engage individuals in research more comprehensively and views DCTs as a stepping stone towards reimagining drug development and fostering a patient-centric ecosystem.

Cerba Research aims to actively contribute to this paradigm shift, positioning medical laboratories as pivotal in enabling more DCTs and supporting diverse clinical and real-world research. They envision creating an ecosystem centred around patients, leveraging their laboratories to drive innovation in clinical research.

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