Assessing the Quality of Decision Making in the Development and Regulatory Review of Medicines: Identifying Biases and Best Practices.

Although the quality of decision making (QDM) in the development and regulatory review of medicines influences the delivery of new products, there appears to be no suitable instrument to assess QDM in this area. The aim of this study was to assess differences in QDM using a validated instrument, the Quality of Decision-Making Orientation Scheme (QoDoS), to identify best practices and biases affecting individuals and their organization, as well as to assess differences in decision-making behaviors between pharmaceutical companies and regulatory agencies. QoDoS also enables the measurement against 10 quality decision-making practices (QDMPs) that underpin a quality process