Proposal of Quality Management in Clinical Trials based on the Concept of ICH Guideline Q8

Abstract

We investigated whether the basic concepts of ICH guideline Q8 “ Pharmaceutical Development” relating to the effective and efficient control of quality in drug development can be applied as a means for the effective and efficient implementation of audits carried out as a part of the quality assurance program for clinical trials in clinical development. We divided the clinical trial into 12 processes. Pharmaceuticals and Medical Devices Agency (PMDA) Inquiries from GCP On-site Inspections and Document-based Conformity Inspections, obtained from the PMDA on the basis of the information disclosure system, were categorized into the 12 processes. As our analysis targets, we chose the “ Revision of written informed consent form with regard to serious adverse events (SAEs)” process, which relates to patient safety, and the “ Examination/Observation/Assessment” process, which generates the highest number of inquiries. These two processes were further divided into several sub-processes. The inquiries were analyzed to tabulate the number of harms in each sub-process and to identify the nature of those events. We then identified the process parameters (PPs) of each process as well as deviations from said PPs (hazards), and tabulated the number of these incidences. We found that the number of harms attributable to said two processes were localized in specific sub-processes. Localization was likewise observed in the nature of the harms, the PPs relating to said harms, and deviations from said PPs. We also identified which sub-processes, the nature of harms,the PPs relating to said harms, and deviations from said PPs require management. Our findings suggest that the basic concepts of the ICH-Q8 guidelines can be applied to the quality assurance programs for clinical trials for the effective and efficient implementation of audits.