The Paradigm Shift in Clinical Trials in the Pharmaceutical Industry: The Economic and Management Implications of Digital Health [before doctoral defense] Technologie

Kivonat, rövid leírás

This doctoral thesis examines the digitalisation of clinical trials in the pharmaceutical industry, and specifically the economic and management implications of digital health technologies (DHTs) related to digital clinical trials (DCTs). The research focuses on exploring how digital solutions influence the cost structure, duration, resource utilisation, data quality and return on investment of clinical trials. The study employed a mixed-methods approach: a systematic review of the literature, 13 expert interviews with a total of 14 participants, and a quantitative questionnaire survey completed by 11 respondents. The results highlight that DHTs and DCTs have the potential to transform the conduct of clinical trials, but their impact is context-dependent. Based on the findings, DHTs present a significant opportunity to transform the conduct of clinical trials; however, their economic and operational impacts cannot be considered automatic or universal. DHTs show particular promise in terms of the volume and quality of data collection, targeted patient recruitment, continuous data collection and the efficiency of certain operational processes. At the same time, initial investment and implementation costs, system integration, cybersecurity, organisational readiness, the regulatory environment, and the burden on patients and trial sites may limit the realisation of the expected benefits. The thesis therefore interprets DCTs not as standalone technological solutions, but as an ecosystem-level transformation determined by complex organisational, economic, technological and regulatory factors. The conditional impact model and decision-support framework developed as a result of the research contribute to a more informed evaluation and management of DCTs.