Poster #086: Risk-based Monitoring: A Global Study Focusing on Perception and Merits Among Clinical Investigational Sites

摘要

Statement of Purpose, Innovation or Hypothesis: Risk-based monitoring (RBM) is aimed at protection of human subjects, improved data quality and ultimately reducing drug development and operational cost. Globally, there is minimal evidence about the perceptions and the level of confidence among the clinical staff on the merits of RBM. The present study focused on assessing the perception among clinical research staff globally as to the applicability and adaptability of RBM. Description of Methods and Materials: Electronic questionnaire surveys were circulated to 3,000 clinical research staff at various global investigational sites. This survey collected information on the use of RBM and factors in those influence assessments of RBM as it relates to clinical trial cost, data quality, subject safety and readiness to adopt RBM practices. Survey responses were summarized and analyzed by respon-ders' demographics and experience in clinical research trials. Data and Results: Responses were received from ten countries, six emerging and four developed. Of the 3,000 surveys sent to emerging (1,000) and developed (2,000) countries, a total response of 595 (261 vs 334) participants was received, respectively. The emerging vs developed cohort had 100 vs 137 participants with complete responses (CR); 34 vs 35 participants with partial responses (PR); and 127 vs 162 participants were disqualified with No Exposure (NE) responses. About 67% of the overall responders were investigators, followed by 23% and 10% coordinator and other staff, respectively. There was a significant difference in feedback between the researchers in developing vs emerging countries (p = 0.02) in regards to their perception of RBM reducing the overall cost of conducting a clinical research. Responders from emerging countries more favorably responded than the responders in the developed countries. Similarly, when asked if RBM will be more effective in addressing data quality (p = 0.006), patient safety (p = 0.05) and findings fraud/fabrication (p = 0.01), researchers from emerging countries indicated more confidence than researchers from developed countries. There was also a significant difference in perception on readiness to adopt RBM between respon-ders of emerging vs developed markets (p <0.0001). Interpretation, Conclusion or Significance: The present study is one of the first to collect evidence and address gaps in the understanding of RBM from a select group of researchers from the community. Further studies involving larger populations and more evidence is recommended to learn more about RBM and its influence globally. We propose establishing a community of clinical trial fraternity with various roles and expertise from both developed and emerging nations to understand global RBM requirements and drive local level pragmatic operational practices. This ethos of collaboration between public, private, government and researchers is critical to harmonizing RBM practices and international recommendations.