STATISTICS OF SIGNIFICANT CHANGES AS A TOOL FOR RISK DETECTION IN CLINICAL RESEARCH PROJECTS

Abstract

The article is dedicated to studying the problem of early risk identification in clinical research projects. The main objective of the study is to find an accessible, reliable, and verifiable method for early risk identification to plan for risks at the early stages of a project, aiming to prevent the occurrence of risks with negative consequences or to mitigate these negative consequences if they arise during the project. The article employed methods of synergetic, comparative analysis, synergetic meta-analysis. The article examines various sources, scientific works by experts in the field of studying and the impact of trends, reforms, practices, and strategies on the economic efficiency and quality of new drug development, e.g., patients` recruitment, patients `retention, clinical project management, patient outsourcing, clinical data collection, regulatory matters in terms of I – IV protocol design strategies. One of the significant aspects explored in the article is the trend in submitting substantial regulatory amendments over the past 12 years. The main result and scientific novelty of the research includes demonstrating the relationship between protocol submissions and the risk events that led to the need for changes, which, in turn, allows project management team to identify a primary risk using information of substantial amendment from the beginning of the clinical trial project. By effectively communicating these risks, decision-makers can incorporate them into their business strategies and make well-informed choices that account for potential challenges. A supplementary advantage of this method is its accessibility. The necessary information can be easily obtained from open sources, including official regulatory agency websites. It is proposed that this information be utilized for an initial risk assessment, followed by the development of a structured register for systematic early risk identification. Implementing such a system will empower project teams within biopharmaceutical companies and contract research organizations to enhance their planning processes, optimize budgets, and establish more accurate timelines for clinical trial projects across various phases. This, in turn, will contribute to more efficient resource allocation, improved project execution, and a higher likelihood of successful clinical research outcomes.