Exploring the Perception of Clinical Researchers on the use and Importance of Decentralized Clinical Trial Elements in India

This study aims to explore the perceptions of clinical researchers in India regarding the use and importance of decentralized clinical trial (DCT) elements and to identify associated organizational and therapeutic area-specific trends.A cross-sectional questionnaire-based survey was conducted among 112 clinical research professionals across various organizational types, including sponsor companies, contract research organizations (CROs), and academic institutions.Data was analyzed to assess the extent of DCT elements importance for its adoption and implementation in the organization based on the drug development pipeline.A statistical test was used to examine the association between organizational type and DCT elements adoption levels.The findings revealed a growing inclination toward hybrid trial models, with 78.6% of respondents indicating partial decentralization within their organizations.Only 11.6% of respondents reported a fully decentralized trial, highlighting regulatory, infrastructural, and operational constraints.A significant association was found between organizational type and DCT adoption (p = 0.045), suggesting that service providers and sponsor companies differ in their strategic approaches.Adoption patterns varied across therapeutic areas, with hybrid models dominating in complex conditions such as oncology and cardiovascular diseases and fully decentralized trials more common in dermatology and infectious diseases.Key enabling technologies included electronic signatures, remote source data verification, and AI-driven analytics, while infrastructure-heavy components like direct-to-patient delivery were less prioritized.DCT element adoption in India remains moderate and is primarily characterized by hybrid models.Service providers are emerging as key enablers of digital transformation, but regulatory ambiguity, gaps in digital infrastructure, and limited organizational readiness hinder broader implementation.Tailored policies, capacity-building initiatives, and therapeutic-specific strategies are essential for accelerating DCT integration.