Journal of Clinical Trials
Open Access

Department of Paediatric Respiratory Medicine, Royal Brompton Hospital, London, UK

Publications

• Research Article   
  Strengthening Clinical Trial Pharmacovigilance: Simple Interventions Improve Communication Over Serious Adverse Events
  Author(s): Rebecca Dobra*, Katherine Huband, Jessie Matthews, Sandra Scott, Nicholas Simmonds and Jane Davies
  
  With over 100 drugs in the development pipeline, this is an exciting time for drug development in Cystic Fibrosis (CF). However, the increased number of trial participants brings challenges. Unscheduled admissions of clinical trial participants are defined as Serious Adverse Events (SAEs). Good Clinical Practice (GCP) guidelines mandate prompt reporting of SAEs to optimise pharmacovigilance and protect patient safety. As our trial cohort grew, so did our trial team, with junior roles becoming trial or clinical specific. Consequently, we encountered delayed awareness by the trials team of unplanned admissions. We conducted a quality improvement (QI) project to empower clinical teams to act as a safety net to alert trial teams to admissions of trials patients to improve patient safety and optimise pharmacovigilance through timely SAE reporting on clinical trials. We show that .. View More»
  DOI: 10.35248/2167-0870.20.S7.001

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