INTRODUCTION
Participant safety is the primary responsibility of those undertaking clinical research. During the early phases of clinical drug development and in experimental medicine studies the risk to participants is proportionately higher due to the comparative lack of information on the investigational medicinal product (IMP, when employed) or intervention, and any benefit indirect, as healthy individuals who may derive no therapeutic benefit are frequently enrolled. The need to reduce or mitigate risk through appropriate study design and conduct, and the presence of robust safety monitoring and governance, is thus imperative.
In both most recent examples in which participants in early phase trials have been seriously harmed, Tegenero (TGN1412) in 2006 and Bial (BIA 10-2474) in 2016, the intervention was the primary source of injury, but the response to the emergency was suboptimal contributing to the overall harm. Issues related to preparedness, communication, training and standardisation played a significant part in affecting the quality of the response. Recommendations and commentary from expert groups following these events has concentrated on the relevance of pre-clinical studies, their interpretation and translation, and subsequent trial design and conduct In contrast, there has been little focus on either the human factors that may influence a drug development programme and the studies that comprise it, nor the development of safer work systems within organisations and facilities that run clinical trials or host them, to protect future study participants and the staff involved in their care .
Safety critical industries have invested significant resources in studying how adverse events manifest. Current thinking supports moving away from regarding the human as the problem after a serious incident and instead analysing safety threats in the work system more broadly. Derived from the field of complex systems , this focus on systemic problems inhibits the unhelpful, reflexive response that sees ‘human error’ as the primary causal factor in safety incidents. This learning has now been extensively applied to the healthcare sector, where human factors methods have been employed to enhance team performance in crisis management and provide safer care in procedural areas with consequent improvement in clinical outcomes . To our knowledge it has not been explicitly extended to research involving human participants.
Through structured observations during the conduct of one experimental medicine study employing a controlled human infection model (CHIM), we sought to identify the potential value of employing human factors methods to identify overt and latent risks in existing study protocols, the local work system and environment of a Clinical Research Facility (CRF), and to generate practical recommendations that could improve safety.