Decentralized Clinical Trials: Revolutionizing Healthcare Research through Remote and Digital Solutions

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Page: 04-06

Maithili Janye¹, Mohamed Natheem², Khushi³, Sayali Kurhade⁴, Shiwani Kumari⁵, and Kuldeep Kumar⁶ (Clinical Research- Fortis Hospitals Limited, Mumbai¹, Trainee Research Scholar- Fortis CSR Foundation & Fortis Hospitals Limited, Bannerghatta Road, Bangalore¹, Fortis Memorial Research Institute, Gurugram, Haryana³, Fortis Hospitals Limited, Mumbai⁴, Fortis Hospitals Limited, Cunningham Road, Bangalore⁵ (Clinical Research Division) Fortis Healthcare Limited⁶)

“What if participating in a clinical trial no longer requires leaving your home?” The answer is Decentralized Clinical Trials (DCTs) differ significantly from traditional clinical trials by emphasizing remote participation through digital tools such as telemedicine, wearable devices, and mobile apps. Unlike traditional trials, which require participants to visit centralized sites, DCTs allow activities like data collection, safety monitoring, and drug delivery to occur at home or in local communities. This approach enhances accessibility, especially for individuals in rural or underserved areas, and improves retention by reducing logistical burdens. While DCTs are more adaptable during disruptions like pandemics, they require robust data security frameworks and equitable access to technology, contrasting with the established infrastructure of traditional trials. The transition to DCTs signifies a shift towards a “patient-centric” model that leverages technology to maintain continuity in trial operations. By utilizing remote visits and monitoring, DCTs promote an environment where participants can engage with research without the constraints of geographical barriers. This approach aligns with regulatory bodies’ efforts to adapt guidelines that support the continuation of clinical research during public health emergencies, ensuring that patient safety and data integrity remain paramount. While DCTs present numerous benefits-including increased diversity among participants and reduced operational costs-they also introduce challenges related to data security, technology engagement, and regulatory compliance. As the clinical research landscape continues to evolve post-pandemic, understanding these dynamics will be crucial for optimizing trial design and execution.