Updated on 13 August 2013
It has also been suggested that a statistical approach to central monitoring can " help improve the effectiveness of on-site monitoring by prioritizing site visits and by guiding site visits with central statistical data checks."
FDA had used a survey conducted through the Clinical Trials Transformation Initiative (CTTI), a consortium of all stake holders involved in drug development, to collate the various types of monitoring undertaken during clinical trials. For major efficacy trials, companies typically conduct on-site monitoring visits approximately at 4-8 week intervals because of the perception that such visits will ensure 100 per cent compliance of trial processes.
Another recent review of on-site monitoring data of a large multi-center international trial along with centralized monitoring analysis of the same data indicated that there was no appreciable differences in the findings. In fact, centralized monitoring process detected more than 90 per cent of the findings done by on-site monitoring of the clinical trial.
Industry leaders are extremely happy with the changed FDA guidelines. Many, however, feel that sponsors may use the new risk-based monitoring only for Phase 2 and phase 4 clinical trials and will continue to do on-site monitoring of critical phase-1 and phase-3 trials of human volunteers where the stakes are very high.
In fact, the new guidelines state that " supplement or reduce the frequency and extent of on-site monitoring activities that can be done as well or better remotely or with monitoring activities that can be accomplished using centralized data processes only."
In recent years, clinical research organizations(CROs) have started using information and database technologies in a big way to store and analyze the voluminous amount of data.
With the FDA encouraging such practices in a big way, a new era of business opportunities will most likely emerge for IT companies worldwide to develop more applications suited for centralized monitoring of clinical trial data.