quality and efficiency of clinical trials.
CTTI Project Cateogy: Study Conduct
Project Status: Complete
U.S. regulations1 require that sponsors be held responsible for oversight of clinical investigations to ensure protection of human subjects and the quality and integrity of resulting data. Although general guidelines for Good Clinical Practice (GCP) are described in the International Conference on Harmonization (ICH) Guideline E6, there is latitude given regarding the extent and nature of monitoring.
Unfortunately, little empirical evidence exists to determine which practices best achieve the goals of trial monitoring stated in ICH E6 across a range of clinical trial settings. This lack of information is concerning, especially given the contention by some in the clinical research field that cumbersome monitoring practices contribute to more work and higher costs for clinical studies. One study suggests that on-site monitoring, commonly used by industry sponsors, can represent approximately 25 to 30% of trial costs.2
Because of growing concern about the effectiveness and efficiency of monitoring practices, the CTTI made monitoring the focus of its first project.
Identify best practices and provide sensible criteria to help sponsors select the most appropriate monitoring methods for a clinical trial, thereby ensuring reliable and informative trial results and human subjects' protection.
Refer to the Products Tab for a complete list of materials and recommendations resulting from this project.