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The landscape of clinical trials has gone through significant transformation in recent years. Adopting decentralized clinical trial (DCT) models has allowed trials to continue amidst challenging circumstances.

It's pertinent to continuously evaluate the enduring benefits and persistent challenges of decentralization in clinical research.

Benefits and Challenges on the Horizon

DCTs have allowed for solutions directly to patients and foster inclusivity among diverse populations. Regulatory agencies globally recognized the merits of decentralization, facilitating easier patient recruitment and participation through innovative approaches, such as direct-to-patient shipments and remote visits.

Regulatory agencies played the pivotal role of embracing decentralization, evident in the issuance of draft guidances and industry surveys, heralding a new era of clinical research methodologies. However, the industry should exercise caution regarding the inherent operational complexities in implementing decentralized models. While executive enthusiasm for decentralization is palpable, operationalizing these models requires meticulous planning and risk-based quality management.

There are concerns regarding the evolving roles and responsibilities at investigative sites, emphasizing the need for clarity amidst regulatory ambiguities. Organizations such as the Decentralized Trial and Research Alliance are pivotal in addressing barriers and promoting best practices in decentralized trials.

Tailoring Solutions to Individual Trials

When considering decentralized solutions, it is important that approaches are tailored to individual trials and sponsors. Factors such as patient preferences, therapeutic indications, and logistical considerations play a crucial role in determining the most suitable decentralized components for a trial. It is also imperative to integrate patient-centric options into trial protocols early in the development phase, ensuring flexibility and inclusivity.

Transformation in Trial Management

The introduction of decentralized components has necessitated a paradigm shift in trial management. There is increased reliance on technology and data analytics for comprehensive feasibility assessments and informed decision-making, which highlights the need for clarity amidst the evolving roles and responsibilities across diverse stakeholders. Enhanced training and support for investigative sites should be provided to make sure everyone is clearly aligned.

Predictions for the Future

There is optimism regarding the continued uptake of DCTs into the future. The patient-centric focus and growing awareness of clinical research among diverse populations signal a promising trajectory for decentralized approaches. However, there is still a need for continued innovation, clarity in regulatory frameworks, and streamlining operational processes to ensure the success and integrity of future trials.

The journey toward DCTs is marked by both opportunities and challenges. As the industry navigates this transformative landscape, collaboration, innovation, and patient-centricity will remain central tenets driving the evolution of clinical research methodologies.

About the Authors
Caroline Redeker, Chief Strategy Officer, Advanced Clinical
Cheryle Evans, Global Clinical & Biometric Operations, Advanced Clinical

About Advanced Clinical
Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research – approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions. Visit our website to learn more: www.advancedclinical.com.