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.