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T-28: Assessment of the Quality Decision-Making Practices; Case Studies with a Pharmaceutical Company, Regulatory and HTA Agency

Poster Presenter

      Magda Bujar

      • Senior Manager, Regulatory Programme and Strategic Partnerships
      • Centre for Innovation in Regulatory Science (CIRS)
        United Kingdom


To assess the incorporation of the ten quality decision-making practices (QDMPs), which are the best practices in decision making during the lifecycle of medicines, through three case studies, with a pharmaceutical company, a regulatory authority and a Health Technology Assessment (HTA) agency.


Individuals from a company, regulatory and HTA agency completed QoDoS, consisting of 47 items, as part of cross sectional-case studies assessing the quality of decision making of individuals and their perception of their organisation’s decision making. The 47 QoDoS items were mapped to the 10 QDMPs.


QoDoS was utilised to assess the incorporation of the 10 quality decision-making practices (QDMPs) in the company, regulatory authority and HTA agency processes. QoDoS was completed by 31 individuals from the company, namely regulatory leadership team (LT) and three safety/regulatory sub teams (SRTs); the LT assessed their approach to decision making and the SRTs assessed themselves and their perception of the LT’s decision making. Results suggest that in general, the three SRTs perceive the practices of the LT as favourable and the results were consistent with how the LT believe they make decisions. QoDoS identified four QDMPs which may need to be improved, namely QDMP 1 (Have a structured approach to decision making), 2 (Assign clear roles and responsibilities), 4 (Evaluate internal and external influences/biases) and 5 (Examine alternatives). Forty responses were received from the regulatory authority, from licensing and post-licensing reviewers, assessing decision-making for evaluating medicines. Results demonstrate that the reviewers perceive their own decision-making practices as ‘favourable’ across all 10 QDMPs, but believe that their agency could improve for QDMP5 (Alternatives) and 8 (Impact). While this could be a sign of bias, or lack of understanding of organisational practices, areas of disparity could also indicate room for improvement to ensure best practice. Finally, 25 responses were received from the appraisal committee members of the HTA agency regarding the decision-making process when recommending the reimbursement of new medicines. The results indicate generally favourable practices, whereas data for QDMP 3, relating to assigning values and relative importance to decision criteria, suggests that this is not consistently carried out by the individuals, but rather at an organisational level. Other practices which may need improvement are QDMPs 5 (Alternatives), 7 (Re-evaluating decision with new information) and 8 (Impact).


Quality of decision making is critical to the sustainability of pharmaceutical companies, regulatory and HTA agencies, firstly to ensure that assessments made by the three stakeholders are scientifically sound as well as being timely, predictable and transparent. In order for organisations to determine how to improve the quality of their decision-making processes, QoDoS instrument was developed and validated. These three case studies were carried out in order to evaluate the incorporation of the 10 QDMPs in a company as well as a regulatory and an HTA agency with QoDoS. These studies demonstrate the applicability of QoDoS to identify favourable and unfavourable practices as well as assess the consistency and transparency of the 10 QDMPs within each organisation. Interestingly, the QoDoS demonstrated the need for improvement across a number of practices where some similarities were identified, such as the need for better evaluation of alternatives for the three organisations and the need for better impact analysis for the agencies. Such an approach can be used to first of all illustrate the factors that influence decision-making in order to provide a basis for internal and external discussions, as well as help build trust into the strategic organisational decisions. Secondly, organisations could utilise the data collected to discuss and address the least favourable practices in order to eventually incorporate them into their decision-making frameworks. This could in turn help improve the productivity of companies and to ensure agencies are not only undertaking a good-quality review or appraisal, but are also making a quality decision. Finally, the overall benefit of routine assessment of quality decision making is to enable an increased awareness of biases and best practices but also provide the ability to measure change over time in order to determine the impact of any improvement initiatives for ensuring best outcomes in decision making.