Preventing potential patient harm through clinical content interventions during oncology clinical trial implementation (October 2023)

Summary

Clinical trial documents are complex and may have inconsistencies, leading to potential site implementation errors and may compromise participant safety. This study characterises the frequency and type of administrative and potential patient safety interventions (PPSIs) made during the review of oncology trial documents for clinical trial implementation by centralized clinical content specialists.

The study demonstrates a gap in patient safety when assessing trial documents for clinical trial implementation. One solution to address this gap is the utilisation of a centralised team of clinical specialists to preemptively review trial documents, thereby enhancing patient safety during clinical trial conduct.