INTRODUCTION
The Coronavirus Disease 2019 pandemic accelerated the adoption of decentralized clinical trials (DCTs), supported by regulatory acceptance of remote data capturing and monitoring (RDCM). Using digital tools, DCTs improve recruitment, retention, and efficiency while enabling participation from remote settings.[1] RDCM enhances data accuracy and oversight, but it faces challenges such as Internet connectivity, inadequate training, and data privacy compliance issues.[2,3] The present study evaluates the key barriers and facilitators of RDCM in DCTs.
METHODS
Study design
A cross-sectional survey was conducted at the clinical research site of a tertiary care hospital in India, using a validated structured questionnaire through Google Forms. The study was approved by the Institutional Ethics Committee (No: KLECOPBGMEC/D011-2025). All participants were provided with voluntary informed consent before participation.
Validation of the questionnaires and data collection
Predeveloped questionnaires were validated by 10 experts who had prior experience in clinical trials, which comprised questions on sociodemographic details and remote data capturing and monitoring (RDCM). Responses were collected from stakeholders of the clinical research team via a Google Form, ensuring accessibility and anonymity.
Statistical analysis
Data were analyzed using IBM SPSS (Statistical Package for Social Sciences) . Descriptive statistics were applied, and results were summarized using frequencies and percentages.
RESULTS
One hundred and thirty-two participants were screened, 120 participants consented, the majority were male (60%), and predominantly, clinical research associates (clinical research associates [CRAs], 45.8%). Most had over 2 years of experience (66.7%) and Master’s degree (66.7%), with Pharmacy (41.6%) and Master’s in Clinical Research (40.8%) as the most common specializations.
Analysis of perceived facilitators of RDCM technology: A frequency- and percentage-based approach
Improved data quality was the most recognized benefit, endorsed by 90.9% of CRAs, 86% of clinical research coordinator (CRCs), and 80% of PIs. Increased patient engagement was acknowledged by CRAs (76.4%) and CRCs (66%), but less by PIs (53.3%). Moderate support was observed for reduced site visits (47.3%–56%). CRAs were the most actively engaged in remote monitoring activities, while CRCs were moderately involved and PIs more selective.
CRAs were most actively involved in remote monitoring, with 92.7% engaged in data entry and 83.6% in protocol compliance, compared to 86% and 72% of CRCs, and 53.3% and 60% of PIs. Ensuring participant safety was prioritized by CRAs (85.5%), PIs (66.7%), and CRCs (64%). CRAs also contributed most to virtual site visits (29.1%) and site team support (58.2%). Overall, CRAs showed the highest engagement, CRCs moderate, and PIs more selective, highlighting the need for role clarification and training to optimize remote monitoring.
Analysis of Perceived Barriers of RDCM Technology: A Frequency- and Percentage-Based Approach
Device-related issues (45.5% CRAs and 28% CRCs) and synchronization problems (84% CRCs and 32.7% CRAs) were the most frequent barriers to RDCM. Incomplete/missing data were noted by 43.6% of CRAs and 30% of CRCs, while data security was a minor concern (<13%). Limited access to site data, communication gaps, and difficulty assessing staff performance reflected reduced face-to-face interaction. The most critical barrier across all groups was inadequate site infrastructure (63.6% CRAs, 50% CRCs, and 53.3% PIs), underscoring the need for stronger technical capacity to support remote monitoring.
DISCUSSION
This study underscores the dual role of remote data capture (RDC) and remote data monitoring (RDM) in DCTs, highlighting both their value and limitations in postpandemic research. Improved data quality was the most consistent facilitator across CRAs, CRCs, and PIs, consistent with previous findings that attributed these gains to real-time entry, reduced errors, and automated validation.[2] Increased patient participation and reduced site visits, reported by site staff,[1] were less favored by PIs, indicating the continuing importance of hybrid models. Real-time monitoring supported compliance and query resolution,[4] while patient safety and trial integrity reinforced confidence in RDCM systems.
Conversely, barriers included device and synchronization issues, incomplete data, and inadequate site infrastructure, which limited RDCM effectiveness. While data security concerns were minimal, communication challenges and difficulties in assessing site performance persisted.[3] Restricted resources additionally hinder adoption, indicating that systemic readiness still needs to be improved.
Overall, RDCM enhances data quality, efficiency, and patient engagement, but its success depends on robust infrastructure and seamless workflow integration. A hybrid approach that combines digital tools with selective on-site oversight appears most pragmatic for future DCT implementation.
Conflicts of interest
There are no conflicts of interest.
Funding Statement
Nil.
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