International Clinical Trials (ICT)
The increasing importance of central statistical surveillance is indicative of the crucial role of statistics and programming in effective clinical trial monitoring. Chitra Lele and Samyuktha Ajay at Sciformix evaluate this risk-based approach.
On-site monitoring is a resource-intensive component of clinical trials, contributing to over 30 per cent of their costs. Moreover, it is estimated that only about 50 per cent of the monitor’s time is actually spent on monitoring activities, while the rest is spent on travel, logistics and reporting. As a result – and in view of the low R&D productivity and major cost pressures on the pharma industry over the past decade – it is hardly surprising that there has been an increased focus on reducing the cost of clinical trial monitoring by making the process more efficient.
Centralised, remote, risk-based and adaptive monitoring are effective strategies which reduce the need for on-site monitoring visits and source data verifi cation (SDV).