ReDPT-CT: Designing Responsible Digital Process Twins for Clinical Trials
摘要
This study explores the intersection of ethics, Business Process Management (BPM), and digital process twins in clinical trials. It investigates the research question: What responsible aspects within business processes can a Clinical Research Center manager consider when assessing the adoption of Digital Process Twins? To address this, a multi-phase methodological approach was employed. First, a structured literature review mapped the ethical landscape of Responsible BPM aspects related to clinical trials and DPTs. Based on these findings, the Responsible Digital Process Twin for Clinical Trial (ReDPT-CT) framework was developed, linking 15 ethical responsibility categories to CRC business process groups—core, support, and management. The study highlights transparency, informed consent, and scientific integrity as the most frequently cited ethical aspects, while also emphasizing emerging areas such as innovation governance and ethical capacity-building. The framework offers a novel contribution by translating ethical principles into actionable digital process design for CRC operations. However, the research is limited by necessity of empirical validation, which is recommended for future studies across diverse research settings. Practically, the framework equips CRC managers with structured guidance for ethical DPTs adoption, while socially, it contributes to building a more trustworthy and participant-centered clinical trial ecosystem.