Failure to report harms and adverse events in clinical trials: Why does the problem continue?

Excerpt

Good Clinical Practice (GCP) is an internationally adopted standard for clinical trials, and one important component of this document is the requirement that investigators inform trial sponsors of serious adverse events, defined as “any untoward medical occurrence that results in hospitalization or prolongation of hospitalization, or is life-threatening, or results in death or disability, including birth defects.”1 In turn, trial sponsors have a duty to notify all trial investigators who must then report the occurrence to their respective Research Ethics Boards (REBs). In contrast, many adverse events that occur in clinical trials are often less serious, and associations (causality) with the intervention are not always clear. Despite internationally mandated reporting requirements, we nevertheless continue to observe that many submitted manuscripts focus primarily on assessments of efficacy and fail to report adverse events and side effects adequately. It is impossible to overstate the importance of documenting adverse events and transparent reporting with regard to patient safety considerations as well as the importance of balancing assessments of efficacy versus risk profile for therapeutic interventions in clinical trials. The purpose of this editorial is to highlight briefly, for the benefit of our readers, the importance of accurate and transparent reporting of adverse events and to encourage clinical investigators everywhere to address this issue when designing a study protocol, executing a trial, and writing trial reports for submission to journals. …