Cross-Disciplinary Assessment of Clinical Trials Transparency and Patient Consent Practices

Abstract

The development of clinical research hinges on the fine line between open science and the autonomy of the participants. The current paper offers an interdisciplinary evaluation of the transparency of clinical trials to the dynamic nature of informed consent (IC). By combining opinions on medical ethics, law, and data science, the analysis reveals a major discrepancy between regulatory requirements (as specified by GDPR and ClinicalTrials.gov) and the actual reporting standards. The main theme of the research is the so-called transparency-privacy paradox, in which the demand to share data to make science reproducible frequently conflicts with technical challenges of de-identifying data and protecting patient privacy. The paper assesses how previous, passive, and non-interactive consent frameworks fail in the era of big data and secondary data process usage, and calls for a shift to the new era of Dynamic Consent. Evidence indicates that evidence-based medicine is still being sabotaged by selective reporting and the file drawer problem. The paper wraps up with strategic suggestions on reducing metadata standardization, improving regulatory compliance, and the adoption of digital-first approaches to consent in order to regain the trust of the people and to streamline the global research ecosystem.