Drug Evaluation Committee Report on Communication Issues when Introducing DCT - Communication Risk Minimization Approach to Maximize the Benefits of DCT - Notice of Public Release
Electronic Standard for Medical Information Expert Committee
Why does the introduction of DCT reduce "patient burden" but increase "on-site burden"?
DCT (Distributed Clinical Trials) is a method to reduce the burden of patient visits, but since many parties are involved, there have been reports of cases where the coordination work of on-site staff conversely increases if the study proceeds without sufficient preparation.
This document summarizes the "structural issues of communication" for each DCT element, which were identified through a survey of companies that have experience implementing DCT, and presents a risk minimization approach to demonstrate the inherent benefits of DCT.
This document is designed to be a single slide for each DCT element and contains a lot of detailed information obtained from the survey, so please extract appropriate information and use it by utilizing AI and other means!
Results of analysis of voices from the field: "Three deep issues" that were highly sympathetic and important.
- Structural aspect: Ambiguity in role assignment leads to concentration of workload on specific jobs (CRC, etc.) and bottlenecks
- Psychological aspect: Unnecessary process of double management of paper and electronic data, which prevents the anxiety of "just in case.
- Cultural aspect: Excessive communication costs due to target setting that deviates from the actual situation (over-quality)
Approaches to solving the issues presented by this document
- Rethinking operational design: "communication map" design to prevent multi-level message games and avoid concentration of workload on CRA/CRCs
- Shift in quality awareness: Consensus building for "Fit for Purpose Quality" by controlling excessive quality
- Element-specific case study analysis: Pre-coordination of possible problems and countermeasures for each element, such as online medical care, home nursing, and clinical trial drug delivery
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Electronic Standard for Medical Information Expert Committee Task Force 3