From collection to confidence: why clinical trial data reliability starts early

Data reliability in clinical trials begins to be built in the first phase and must be embedded in study design, risk-based quality management, monitoring, and corrective actions. Data are reliable when they are not only accurate but also complete, transparent, and sufficiently understood to support decisions. In early-phase trials, incomplete or erroneous data are critical because they can lead to selection of the wrong dose or incorrect design of subsequent phases. According to GlobalData database figures, between 2021 and 2026, 8,683 trials were discontinued in Phase II, 4,085 in Phase I, and 2,318 in Phase III. The most common reasons for trial discontinuation were low accrual rate (9,410 cases), lack of efficacy (2,222 cases), and adverse events (1,203 cases). Sponsors should monitor data reliability from the beginning, including analysis of protocol deviations, query management, and implementation of corrective actions.