Abstract

This paper explores the usability and applicability of STAMP (System-Theoretic Accident Model and Processes) in managing risks associated with the development of new drugs. STAMP is used in the context of other existing but non-standardly implemented risk management approaches and tools. The STAMP accident model uses system theory and treats safety as a control problem rather than a failure problem. This paper uses the well-publicized TGN1412 incident where human volunteers suffered severe adverse reaction to trial therapy doses. STAMP can be utilized in the in optimization of enterprise risk management systems within the domain of drug development and clinical research.

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