薬経済学: オープンアクセス

Data Quality Assurance in Clinical Trials: Best Practices and Challenges

Abstract

Johann Eolfgang

Clinical trials are a cornerstone of medical research and drug development, serving as the primary means to evaluate the safety and efficacy of new treatments and interventions. The data generated from these trials are not only critical for regulatory approvals but also have a profound impact on patient outcomes. Ensuring the quality and integrity of clinical trial data is paramount, as flawed or unreliable data can have far-reaching consequences, from wasted resources to compromised patient safety. In this comprehensive discussion, we delve into the world of data quality assurance in clinical trials, exploring the best practices and challenges that researchers, sponsors, and regulatory authorities face in their pursuit of rigorous data integrity.