Analysing two serious incidents in clinical research from a systems theory perspective

Analysing two serious incidents in clinical research from a systems theory perspective

• anthony vacher (Armed Forces Biomedical Research Institute)
• Yannick Bardie (University Montpellier I)
• Monica Pollina (Independent pharmacoepidemiologist)
• Myra Daridan (CC Clinical research Consultants)
• Brian Edwards (NDA Regulatory Science Ltd)

Abstract

Ensuring the safety of volunteers that participate in clinical trials involving healthcare products (drugs, medical devices) but how to ensure this effectively is a subject of debate in clinical research. This is especially so when healthy volunteers choose to enter Phase I (first-in-human) trials where any serious incident is unacceptable and undermines the confidence in the whole healthcare industry. As in others industries, safety management of clinical trials rely mainly on a traditional view that aims to avoid serious incidents by the identification of hazards, the development of safety barriers (technological barriers, procedures, regulation, laws) to prevent and mitigate risks, and the strict compliance of operators with these safety barriers. This traditional view of safety management is recognised as no longer sufficient to maintain safety in a dynamic, complex, and competitive environment where changes and perturbations are permanent, and the pace of technological innovations is high. In that respect, a group of individual pharmacology and clinical professionals have argued for the need to introduce the principles and methods from human factors and systems theory into the process of safety investigations following serious incidents occurring in clinical research. In this perspective, an international, interdisciplinary and multi-stakeholder collaboration was established to explore the feasibility to transpose human factors and systems theory methods to the specific context of an investigation of serious incidents that occurred during phase I-trials. The Causal Analysis using System Theory method was applied to two emblematic serious incidents, one in London (United Kingdom) in 2006 and one in Rennes (France) in 2016. These two serious incidents have benefited from extensive investigations by both stakeholders and authorities afterwards to identify their root-causes and propose remedial actions to avoid their recurrence.

Biography - anthony vacher

After a residency in military and aerospace medicine, I had joined the Cognitive Ergonomics Unit of the Armed Forces Biomedical Research Institute in 2006.

In this unit, after a Ph.D. in ergonomics, I conduct research projects on decision-making and safety culture in risky environments, such as Defense, aeronautics and healthcare. Our unit is the reference laboratory of the French State Aviation Accident Investigation Board.

In 2017, our unit has joined an initiative lead by European pharmacologists that aims to introduce human factors and systemic approach to the safety management of early phases of clinical research involving healthcare products.

Topics

• Systems ergonomics
• Cognitive ergonomics
• Human factors and safety
• Applications of systems ergonomics to complex work environments

Additional Info

Concise title of your presentation:	Systemic approach applied to clinical research
ODAM 2020 - Practitioners' Stream:	No

Other Properties

Track:	ODAM2020
Presentation Format:	Short Talk (10 mins + 5 for questions)
Student Submission:	No
Submission ID:	133

Odam-2020-abstract-vacher final.docx