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M 02: Factors Influencing Quality Decision Making in Medicines Development and Regulatory Review

Poster Presenter

      Magda Bujar

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


To assess the quality of decision-making (QDM) by organizations and individuals in order to identify strengths and weaknesses, increase awareness of biases and best practices, and evaluate differences in decision-making behaviors between pharmaceutical companies and regulatory agencies.


The Quality of Decision-Making Orientation Scheme (QoDoS) consisting of 47 statements that measure organizational and individual decision-making approach and influences, was completed by 76 participants from regulatory agencies and companies. The data were analysed using descriptive statistics.


Thirty-eight individuals (male=27, female=11) from 12 agencies and 38 (male=22, female=16) from 23 companies participated in the study representing small and large organizations with varying levels of professional experience (range= 2-40 years). QoDoS enables measurement against 10 key principles that underpin quality decision-making practices; having a systematic, structured approach to aid decision-making (consistent, predictable and timely); assigning clear roles and responsibilities (decision makers, advisors, contributors); assigning values and relative importance to decision criteria; evaluating both internal and external influences/biases; examining alternative solutions; considering uncertainty; re-evaluating as new information becomes available; performing impact analysis; ensuring transparency and providing a record trail; and effectively communicating the basis of the decision. Assessment against these principles was evaluated across the 76 participants. Applying a structured approach to decision-making, ensuring consistency, transparency and timeliness, were incorporated more at the individual level of decision-making (22% of participants indicating always) while this was only reflected at the organizational level for 7% of the participants. An assessment of agency and company responses identified differences between the two stakeholders. Both groups considered evaluating the impact of the decisions as an important factor with agencies using a structured, systematic approach to decision-making more frequently than companies. Conversely, there was a general tendency for biases, due to politics, competitors or incentives, to have more impact on decision-making for companies compared to agencies. Whilst it was recognized that the science of decision-making is important, training in this area was rarely provided. Nevertheless, all responders from agencies and 92% from companies felt that they could make better decisions.


In the absence of a standardised valid instrument for measuring QDM in the pharmaceutical regulatory environment (Bujar et al. 2016), the QoDoS was developed using a standard approach for design and psychometric evaluation for measures of such nature (Donelan et al. 2015, 2016). This study has demonstrated that some QDM practices, such as having a systematic, structured approach to aid decision-making, are applied to a greater extent at an individual level compared to that of organizational. This could relate to factors such as an individual being more accountable at a micro-level for the decisions they make as compared to the organization on a macro-level. Whilst it was recognized that both agencies and companies felt that their decision-making could be improved, training in this area was rarely provided. Consequently, there is a need to utilise tools and frameworks to build quality into decision-making in association with other available approaches such as the implementation of benefit-risk assessment methodologies and good review/submission practices. The findings of this study also demonstrate that the QoDoS has the ability to measure differences in decision-making and identify best practices between individuals and their organization as well as differences between companies and agencies. The overall benefit of assessing the quality of decision-making practices 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 improvement initiatives. In addition, the long-running use of quality systems for making decisions will generally give better outcomes for companies and agencies. Finally, such measurements of QDM will enable trust, consistency, transparency and timeliness to be built into critical decisions that ultimately improve patients’ access to medicines.

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