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Use Of Comprehensive Solicited Event Reporting For Safety Monitoring In Clinical Trials With Standard Of Care Drugs


Conference Paper

Fu C; Easton V; Reardon E; Humphrey K; Lipscomb D; Chen J; Turdalieva S; Martz K; Payne EH; Kondapaka R; Simone G

2021 Society for Clinical Trials Annual Meeting



Trial Design Statistical Analysis Data Management

Safety reporting in traditional clinical trials is often accomplished through investigator’s independent identification of events meeting Adverse Event (AE) reporting criteria. In some study settings, such as observational or standard of care based research, the subjectivity in this reporting approach can result in gaps or inconsistencies in safety data, limiting the ability to confidently confirm both presence and absence of key events. The Emmes CRO has adopted a new approach for clinical research studies to improve upon the traditional, passive, non-specific collection of Adverse Events (AE) with a more targeted solicitation of study specific Events of Special Interest (ESI). ESIs may be derived from the drug labels, package inserts, or known disease indications, and ensure consistency and uniformity in safety data collection across sites and similar studies. ESI reporting aims to target specific events and avoids over or under reporting by sites. ESIs also reduce the burden of site reporting of irrelevant events, the need to determine if an event is or is not reportable, such as in a sick patient population, and finally supports efficient data and safety monitoring in alignment with FDA IND Safety reporting guidance. The Emmes CRO has adopted this approach to ensure comprehensive data collection in support of improved labeling for marketed products in pediatric and adolescent populations. It has proven most effective in observational or standard of care (SOC) studies , particularly those with sick and/or in-patient populations. Safety event data is bolstered with site required confirmation of occurrence in an unequivocal No or Yes manner, along with the addition of severity, causality, and association assessments by the clinician/subject matter expert (SME). ESIs are study defined events, aiding study staff or programmatic searches of health records in the identification and abstraction of event data. ESIs also allow researchers to more accurately tabulate event frequency and rates, as well as assist sponsors in identifying site reporting imbalances. Clinical research is constantly evolving, driven by the need to optimize data collection and reduce time, effort, and cost, which is particularly important for trials being implemented during the COVID-19 pandemic. The traditional methods used to collect safety data require a high level of effort to collect, review by numerous SMEs, and can often result in the collection of large amounts of data that are irrelevant to research objectives. This utilization of safety reporting and analysis to include ESIs, has been shown to significantly reduce the level of effort to collect, SME review, MedDRA code, and tabulate safety data. By improving data collection consistency and uniformity, utilization of ESI reporting has improved the overall process of safety event reporting in our clinical research, increasing the efficacy of study data utilized to inform regulatory authorities.

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