New approaches of clinical trial monitoring

Monitoring is one of the critical quality control approaches in the conduct of clinical trials. Traditional on-site monitoring is a frequently employed procedure. With the wide application of electronic capture system, increased complexity of clinical trials, and the involvement of the third parties, biopharmaceutical companies, regulatory agencies, and academic groups in US and Europe have initiated a series of survey and discussions in order o compare the cost-effectiveness and make the best use of the resources. The proposed suggestions were as follows: The more efficient centralized off-site monitoring should be encouraged. In addition, it is necessary to identify the key risk factors by risk-based analysis monitoring. Increasing the flexibility of monitoring frequency, depth and methods has also been recommended. Stakeholders should explore appropriate new monitoring approaches through broad adoption, thus to improve the quality and efficiency of clinical trials.