Clinicial trial business process management supported by digital twins

• Grant number: 23/08335-3
• Support Opportunities: Regular Research Grants
• Start date: October 01, 2023
• End date: September 30, 2024
• Field of knowledge: Applied Social Sciences - Administration - Business Administration
• Agreement: Technische Universität Berlin (TU Berlin)
• Mobility Program: SPRINT - Projetos de pesquisa - Mobilidade
• Principal Investigator: Silvia Inês Dallavalle de Pádua
• Grantee: Silvia Inês Dallavalle de Pádua
• Principal researcher abroad: Rainer Stark
• Institution abroad: Technical University of Berlin (TU), Germany
• Host Institution: Faculdade de Economia, Administração e Contabilidade de Ribeirão Preto (FEARP). Universidade de São Paulo (USP). Ribeirão Preto , SP, Brazil
• Associated researchers: Eduardo Barbosa Coelho ; Hajo Alexander Reijers
• Associated research grant: 21/14363-4 - Business Process Management (BPM) in clinical research centers: understanding the relationship between BPM culture, BPM methods and process performance, AP.R

Abstract

The management practices of healthcare organizations involved in clinical research have a significant impact on the development of new drugs or medical equipment. The dynamic nature of the healthcare sector requires organizations to adapt to emerging demands and operationalize their processes accordingly. Business Process Management (BPM) is an organizational management approach that focuses on delivering value to customers through end-to-end processes. BPM encompasses all the work performed by an organization in delivering products and services, regardless of functional areas or locations involved. Clinical research plays a crucial role in university hospitals, encompassing various types of studies, such as epidemiological, therapeutic interventions, prevention, health promotion, and behavioral and health service evaluation research. Multicenter studies require innovation and specialized resources. Understanding the influence of business processes on the performance of Clinical Research Centers (CPCs) is crucial for managers and collaborators seeking improvements in management. Clinical trials are conducted in clinical research centers (CRCs) or clinical research units (CRUs), responsible for operational and management decision-making during the study. CRCs provide investigational drugs or technologies to participants, who are evaluated by research protocol teams during scheduled visits. Each CRC makes managerial and operational decisions based on their specific context, including task organization, participant recruitment methods, resource allocation, budget analysis, and resource availability. Digital twins, originally rooted in systems engineering, have evolved to extend beyond physical product replication and into services and processes. By creating digital replicas based on underlying causal models, digital twins provide insights into operational systems, enabling predictions, prescriptions, and remote control of actuators. They can monitor and forecast process aspects, offering recommendations for effective process management. Digital twins can be implemented at different complexity levels and through various technologies, resulting in a heterogeneous landscape of digital twin maturity in the industry. Clinical research centers seek data to better understand the business of clinical trials and compare themselves with similar institutions. The application of BPM can enhance communication, reduce errors, plan and execute different paths, and provide quality data, thus increasing flexibility and dynamism in healthcare organizations. Effective management techniques are crucial in response to protocol needs and increased regulatory monitoring. In conclusion, these research exchange missions aim to explore the application of digital twins in clinical trial business process management. The missions involve collaboration, knowledge sharing, and industry insights, contributing to advancements in clinical trial processes supported by digital twins. (AU)