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Br J Clin Pharmacol. 2017 Nov;83(11):2339-2342. doi: 10.1111/bcp.13353. Epub 2017 Jul 19.

A call to incorporate systems theory and human factors into the existing investigation of harm in clinical research involving healthcare products.

Author information

1
Principal Consultant NDA Regulatory Science Ltd and Vice-President Alliance Clinical Research Excellence & Safety, Leatherhead, UK.
2
Département de Pharmacologie Médicale, Université de Bordeaux, France.
3
Clinical Research Professional, TRIUM Clinical Consulting NV, Ghent, Belgium.
4
Civil Engineering Department, Democritus University of Thrace, Xanthi, Greece.
5
Safety and Commercialization Services at PRA Health Sciences, Philadelphia, USA.
6
Janssen Research and Development, LLC, Titusville, NJ, USA.
7
Pharmacology & Experimental Therapeutics, Thomas Jefferson University, Philadelphia, USA.
8
F. Hoffmann-La Roche Ltd., Basel, Switzerland.
9
Head of Pharmacovigilance Fédération Assistance Publique Hôpitaux de Paris, President of Council for International Organizations of Medical Sciences, Past President of International Society of Pharmacovigilance, Pharmacovigilance Risk Assessment Committee (PRAC) member, Paris, France.
10
Past Senior Vice President and Managing Director Europe, Middle East and Africa, Drug Information Association, Past Executive Director, Danish Medicines Agency, Copenhagen, Denmark.
11
Research Associate Department of Computer Science University of Bath, Bath, UK.
12
Fellow of the Faculty of Pharmaceutical Medicine, Managing Director of Owen Clinical Consulting Ltd., Manchester, UK.
13
Marketed Product Safety Services, Quintiles IMS, Dublin, Ireland.
14
Deputy Head of the Safety-Critical Systems Research Lab, Zurich University of Applied Sciences (ZHAW), Zurich, Switzerland.
15
Department of Adverse Reactions, Division of Clinical Trials, National Medicines Agency (EOF), Athens, Greece.
16
Clinical Pharmacology Unit, University of Edinburgh, Edinburgh, UK.
17
Alliance for Clinical Research Excellence and Safety (ACRES), Baltimore, USA.
18
Whiteley Aerospace Safety Engineering & Management Limited, Salisbury, UK.

Abstract

This is a joint statement from individual pharmacology and pharmaceutical professionals acting in their own capacity, including members of the Alliance for Clinical Research Excellence and Safety (ACRES) and the International Society of Pharmacovigilance (ISoP). By building on the extensive pharmacological and regulatory investigations that already take place, we are calling for a fuller and more robust systems-based approach to the independent investigation of clinical research when serious incidents of harm occur, starting with first-in-human clinical trials. To complement existing activities and regulations, we propose an additional approach blending evidence derived from both pharmacological and organizational science, which addresses human factors and transparency, to enhance organizational learning and continuous improvement. As happens with investigations in other sectors of society, such as the chemical and aviation sector, this systems approach should be seen as an additional way to understand how problems occur and how they might be prevented in the future. We believe that repetition of potentially preventable and adverse outcomes during clinical research, by failing to identify and act upon all systematic vulnerabilities, is a situation that needs urgent change. As we will discuss further on, approaches based on applying systems theory and human factors are much more likely to improve objectivity and transparency, leading to better system design.

KEYWORDS:

first-in-human; human clinical research; human factors; independent investigation; systems engineering

PMID:
28681444
PMCID:
PMC5651324
DOI:
10.1111/bcp.13353
[Indexed for MEDLINE]
Free PMC Article

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