Current Edition

Is Risk-based Monitoring an Appropriate Methodology for Clinical Trials in Emerging Regions?

When it comes to emerging regions – where sites and monitors generally have less experience in clinical research than those in North America and Western Europe, the conventional wisdom is that study teams need to apply more rigorous on-site monitoring, as the level of compliance and quality is expected to be problematic. Stephen Young, Kyle Given, and Laurie Falkin of Medidata Solutions ask whether sites in emerging regions are indeed showing signs of lower quality that warrant more intensive scrutiny in a risk-based monitoring paradigm.