Risk indicator taxonomy for supervision of clinical trials on medicinal products

Aim: To facilitate a risk-based approach for the supervision of clinical trials on medicinal products, we identified and categorized indicators that may present an elevated safety and/or ethical risk for participants, and/or for data integrity. The indicators are relevant for all stakeholders includ...

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Bibliographic Details
Published in:Current medical research and opinion 2016-07, Vol.32 (7), p.1269-1276
Main Authors: Jongen, Peter M.J.M., van den Bogert, Cornelis A., van de Laar, Catharina W.E., Notenboom, Kim, Hille, Elysée T.M., Hegger, Ingrid
Format: Article
Language:English
Subjects:
Biomedical Research - ethics
Biomedical Research - organization & administration
Biomedical Research - statistics & numerical data
Clinical trial
Clinical Trials as Topic - ethics
Clinical Trials as Topic - organization & administration
Clinical Trials as Topic - statistics & numerical data
Data integrity
Ethics
Humans
Investigational medicinal product
Risk
Risk assessment
Risk Factors
Risk indicator
Safety
Supervision
Taxonomy
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Summary:Aim: To facilitate a risk-based approach for the supervision of clinical trials on medicinal products, we identified and categorized indicators that may present an elevated safety and/or ethical risk for participants, and/or for data integrity. The indicators are relevant for all stakeholders including participants, regulatory bodies, health care inspectorates, sponsors and trial sites. Methods: The sources of indicators included Medline (using the search terms risk-based/-triggered/-driven oversight/monitoring/inspection), relevant documents from websites of regulatory authorities in Europe, North America and Australia, and results of a brainstorm session organized for experts working in the field. Indicators were classified according to risk area (safety and ethical, data integrity, or both). Results: In total, we identified 69 risk indicators that were categorized into six branch-levels of the taxonomy. We visualized the taxonomy in a tree structure to clearly distinguish individual indicators. In addition to readily detectable risk indicators, more context-related aspects determine the final impact of the trial and constitute further components in risk assessment. Context-related aspects include potential high media attention, consequences for the reputation of medical research, and the socioeconomic situation in the geographic region and have to be considered on a case-by-case basis. Conclusions: We identified a wide array of risk indicators for clinical trials on medicinal products and we used a tree structure to incorporate the indicators identified to clearly distinguish individual indicators and to enable efficient use of the indicators. The overview of indicators may facilitate multiple stakeholders in developing structured risk assessment (identification and analysis) for supervising clinical trials on medicinal products. Stakeholders can interpret and prioritize the indicators from their own perspective.
ISSN:0300-7995
1473-4877
DOI:10.1185/03007995.2016.1170671