Navigating Protocol Integrity: Unraveling Deviations and Violations in Clinical Trials

Description

Page: 54-58

Shweta Rai¹, Khushi², Kainat Hussain³, Kritika Sharma⁴, Maithili Janye⁵, and Kuldeep Kumar⁶ (Fortis CSR Foundation (Clinical Research Division) and Fortis Healthcare Limited^{1,2,6 ,} Department of Clinical and Translational Research Jamia, Hamdard university^3,4 Fortis Hospitals Limited, Mumbai⁵)

Protocol integrity is a keystone of clinical trials, make sure that research adheres to predefined methodologies, ethical guidelines, and scientific principles. However, deviations and violations from the protocol can undermine the validity of study outcomes and compromise patient safety. This paper explores the critical role of maintaining protocol integrity in clinical trials, focusing on the causes, consequences, and management strategies for protocol deviations and violations. Protocol deviations may arise due to patient-related factors, investigator decisions, or logistical challenges, while violations typically reflect more significant breaches of ethical or regulatory standards. Both deviations and violations can lead to biased results, increased risk of harm to participants, and regulatory consequences, affecting the credibility of trial findings. This review examines the common types of deviations and violations, offering insights into detection, reporting, and corrective actions. Additionally, it reiterate the importance of proactive monitoring, training, and clear communication in minimizing violation of procedure. By understanding and addressing these challenges, researchers can uphold the scientific rigor and ethical standards essential for the success of clinical trials, ultimately advancing medical knowledge and improving patient outcomes.