INTRODUCTION The COVID-19 pandemic catalyzed a major transformation in clinical research, promoting decentralized clinical trials (DCTs) that integrate telemedicine, remote monitoring, and digital data capture. These models enhance accessibility and continuity while reducing on-site dependency.1-3 Despite their global expansion, implementation in low- and middle-income countries, including India, remains limited due to infrastructural and regulatory constraints.4-7 India’s evolving digital health ecosystem–fueled by the Ayushman Bharat Digital Mission–provides fertile ground for adopting DCTs. Yet, investigator readiness, operational feasibility, and perceived barriers in this context are underexplored. This study aimed to assess Indian investigators’ perspectives on the challenges, benefits, and strategies for implementing DCTs. METHODS A cross-sectional, descriptive online survey was conducted between June 2025 and September 2025 among clinical trial investigators in India. Eligible participants were physicians or researchers serving as principal or co-investigators in registered clinical trials. Recruitment occurred through professional networks using purposive sampling to ensure diversity. The survey, developed from prior literature2,8-10 and pilot-tested among five investigators, included 25 items covering demographics, awareness, perceived benefits, challenges, and open-ended feedback. Participation was voluntary and anonymous, with implied consent through submission. Ethical exemption was obtained from the Institutional Ethics Committee as the study posed minimal risk. Quantitative data were summarized descriptively, and open-ended responses underwent thematic content analysis by two independent reviewers. RESULTS Fifty investigators responded, representing internal medicine, oncology, pharmacology, and surgery. Most (84%) were affiliated with tertiary hospitals, and the majority had over 5 years of research experience. Perceived benefits Most investigators endorsed DCTs for improved patient retention (89.8%), enhanced accessibility (85.7%), and real-time data collection (79.6%). Respondents highlighted that decentralized models could expand participation among patients in remote regions. Digital experience Two-thirds (66%) reported no prior use of decentralized technologies. Among those with experience, electronic patient-reported outcome systems and teleconsultations were most common, while e-consent and wearables were rarely used. Key challenges Investigators identified protocol compliance (71.4%), safety reporting (59.2%), and data privacy (57.1%) as major concerns. Limited digital literacy and absence of standardized regulatory guidance were recurrent themes. Several respondents expressed apprehension about reduced clinical oversight and difficulties verifying adverse events remotely. Proposed strategies Capacity-building workshops (83.7%), multilingual technical support (77.6%), provision of reliable digital infrastructure (69.4%), and national-level regulatory guidance (57.1%) were suggested. Simplified interfaces, structured training, and participant education were emphasized to mitigate data quality and compliance issues. DISCUSSION This study provides early empirical insights into investigator perceptions of DCT implementation in India. Consistent with international reports,3,5,11-14 respondents recognized DCTs’ potential to improve patient reach and retention but identified challenges in data integrity, technological readiness, and oversight. Digital literacy emerged as a major barrier, echoing findings from global studies where the lack of training among investigators impeded DCT adoption.3,13 Embedding DCT-specific modules in Good Clinical Practice training and fostering public–private partnerships for technology enablement could bridge this gap. Regulatory ambiguity remains a significant impediment. Unlike the U.S. FDA (2023) and EMA (2022), which emphasize risk-based monitoring and participant safety in remote models.6,7 India lacks formal DCT guidance. Formulating clear frameworks through the Central Drugs Standard Control Organisation could align Indian practice with international standards and encourage sponsor confidence. Operationally, investigators expressed concern about safety reporting and reduced clinical oversight–issues central to participant protection. Robust cybersecurity systems, validated digital tools, and standardized procedures for e-consent and remote monitoring are essential to maintain data quality and ethical conduct. While this survey reflects perspectives from a modest sample of 50 investigators, it highlights critical gaps in readiness and regulation. Broader multicentric assessments incorporating patient and sponsor views could strengthen evidence for policy reform. DCTs offer transformative potential for patient-centric research in India but face significant infrastructural, operational, and regulatory challenges. Strengthening digital infrastructure, implementing national DCT guidelines, and institutionalizing investigator training can enhance feasibility and ethical rigor. Collaborative initiatives among regulators, sponsors, and academic institutions are pivotal to realizing equitable and secure DCT adoption in India. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.
Ghotankar et al. (Sat,) studied this question.