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Strengthening Clinical Trial Pharmacovigilance: Simple Interventions Improve Communication Over Serious Adverse Events

Rebecca Dobra, Katherine Huband, Jessie Matthews, Sandra Scott, Nicholas Simmonds, 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 simple interventions can substantially increase the percentage of clinical staff who routinely ask about trial participation at admission, the percentage of staff who would inform the trial team of an admission if they identified that a patient is on a trial, and the percentage of clinical staff who know how to contact the trials team. This significantly reduced the number of days until trial teams became aware of admissions of trial patients from a median (range) of 18(2-93) days to 1(1-3) days (p<0.0001). This is likely to benefit patient safety through ensuring SAE reporting requirements are met.

Our findings have relevance to improving pharmacovigilance through timely SAE reporting across many disciplines conducting clinical research with chronic disease cohorts. With increasing recognition of the need to improve standards of care for research patients, we encourage other research-active teams to implement such interventions to improve patient safety. We especially suggest increasing trial activity visibility to clinical teams, who recognised how their engagement in research can benefit patient safety and their own professional development.