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Leveraging electronic data capture (EDC) systems to optimize pharmacovigilance in clinical trials



Kondapaka, Radhika; Hoehn, Anne; Van Veldhuisen, Paul; Shmueli-Blumberg, Dikla; Lindblad, Robert

SCT Annual Meeting

Liverpool, UK


Information Systems & Technology Data Management Trial Management & Research Coordination

Pharmacovigilance (PV), also referred to as drug safety, is defined as the pharmacological science and activities related to the detection, assessment, understanding and prevention of adverse effects or other drug-related problems (WHO, 2002). Monitoring patient safety is an essential component of conducting clinical trials and members of the PV team are highly skilled medical and safety professionals with regulatory and safety experience. However, due to the sheer magnitude of Adverse Events (AEs) collected in many clinical trials, it is vital to utilize innovative EDC technologies in order to improve quality and efficiency of PV activities. Developing the safety electronic case report forms (eCRFs) in a thoughtful and systematic way before the start of a trial can enhance data quality, facilitate coding procedures, and enable more rapid drug safety decisions. Certain adverse event terms can be predetermined on the eCRFs to reduce the number of varied but similar terms, and to categorize into protocol-specific events of interest (e.g., seizures) to allow for desired organization of large amounts of data. This can greatly reduce the preparation time for Data and Safety Monitoring Board (DSMB) review and other reporting needs. Technical capabilities also allow for automated notifications to be triggered based on the use of a specific term, severity grade, or causality designation. For example, the PV team can be notified whenever a ‘related’ AE is entered in the EDC system, or when lab values exceed a certain threshold. Leveraging the EDC capabilities optimizes the function of the clinical trial pharmacovigilance practices, provides real time monitoring of safety events, and can be made accessible for sponsors or DSMB members as needed. This presentation will discuss best practices for utilizing EDC systems to facilitate clean well-organized safety data and increasing the efficiency of pharmacovigilance activities throughout the life of a trial.

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