Decentralised clinical trials in India: Stakeholders' perspectives

Background and objectives Decentralised clinical trials leverage digital technologies to enhance trial accessibility, patient engagement, and improve operational efficiency in clinical research. This study assesses the adoption of these trials among 47 Indian clinical research site professionals from a global survey (n=288). Methods A sub-analysis of a global cross-sectional survey conducted between August-September 2024 assessed respondents' roles, experience, trial types, therapeutic areas, perceived benefits, challenges, patient satisfaction, and expectations from the Indian researchers involved in decentralised clinical trials. Data were analysed using descriptive statistics, weighted averages (scale: 1=significant challenge to5=significant benefit), and mean rank analysis. Results Hybrid trials (n=33;71%) were more prevalent than full trials (n=14;29%). Frequently adopted components included home health visits and remote monitoring (n=10;16% each), particularly in oncology (n=8;17%) and cardiovascular trials (n=7;15%). Key perceived benefits included improved patient convenience (mean score: 3.8) and enhanced participant diversity (3.5). The most significant challenges were limited digital literacy (2.3) and regulatory uncertainty (mean rank 6.1). Patient satisfaction averaged 4.0, with 83% of respondents anticipating continued growth in adoption of hybrid trials. Interpretation and conclusions Hybrid decentralised clinical trials offer promising avenues to enhance inclusivity and efficiency in India's clinical research landscape, especially for non-communicable diseases. Gaps in digital literacy and regulatory uncertainties hinder their scale-up. Strategic investments in workforce training, digital infrastructure, and regulatory clarity are critical to unlocking the full potential of decentralised trials.