Magdalena Bujar1,2, Neil McAuslane1, Sam Salek2,3, Stuart Walker1,4. 1. 1 Centre for Innovation in Regulatory Science (CIRS), London, United Kingdom. 2. 2 Department of Pharmacy, Pharmacology & Postgraduate Medicine, University of Hertfordshire, Hatfield, United Kingdom. 3. 3 Institute for Medicines Development, Cardiff, United Kingdom. 4. 4 School of Pharmacy and Pharmaceutical Sciences, Cardiff University, Cardiff, United Kingdom.
Abstract
BACKGROUND: The science of decision making is well established, although in reality it is a mixture of science and art. What is currently lacking is research into decision making in medicines research and development. The aims of this study were to determine the current decision-making practices and methodologies for measuring the quality of the decision making and the barriers and solutions for making quality decisions within pharmaceutical companies and regulatory agencies. METHODS: Two analogous questionnaires were developed for use in this study. Fourteen agencies and 25 companies were asked to complete the questionnaire, assessing their decision making for submitting or approving a new drug application. RESULTS: The 68% and 71% response rate from companies and agencies, respectively, suggests interest in this topic, but the area is largely unexplored within the pharmaceutical environment. Moreover, all companies and 90% of the agencies believed that decision making at their organizations could be improved. Although both stakeholders have, to some extent, already implemented frameworks and various methodologies, these are often informal and unsystematic. Challenges remain and there is a need to change the organizational culture by increasing the awareness of the quality aspect in decision making. CONCLUSIONS: The findings of this study support the need to further characterize and assess the practices and behaviors of individuals and organizations. Furthermore, the barriers, mainly relating to the influence of biases, should be addressed by developing the general principles of a formal quality decision framework and identifying quality decision-making practices in order to ensure that structured decisions are made throughout the life cycle of medicines.
BACKGROUND: The science of decision making is well established, although in reality it is a mixture of science and art. What is currently lacking is research into decision making in medicines research and development. The aims of this study were to determine the current decision-making practices and methodologies for measuring the quality of the decision making and the barriers and solutions for making quality decisions within pharmaceutical companies and regulatory agencies. METHODS: Two analogous questionnaires were developed for use in this study. Fourteen agencies and 25 companies were asked to complete the questionnaire, assessing their decision making for submitting or approving a new drug application. RESULTS: The 68% and 71% response rate from companies and agencies, respectively, suggests interest in this topic, but the area is largely unexplored within the pharmaceutical environment. Moreover, all companies and 90% of the agencies believed that decision making at their organizations could be improved. Although both stakeholders have, to some extent, already implemented frameworks and various methodologies, these are often informal and unsystematic. Challenges remain and there is a need to change the organizational culture by increasing the awareness of the quality aspect in decision making. CONCLUSIONS: The findings of this study support the need to further characterize and assess the practices and behaviors of individuals and organizations. Furthermore, the barriers, mainly relating to the influence of biases, should be addressed by developing the general principles of a formal quality decision framework and identifying quality decision-making practices in order to ensure that structured decisions are made throughout the life cycle of medicines.
Keywords:
framework; new drug application; quality decision making; regulatory agency; submission and approval
Authors: Bethea A Kleykamp; Robert H Dworkin; Dennis C Turk; Zubin Bhagwagar; Penney Cowan; Christopher Eccleston; Susan S Ellenberg; Scott R Evans; John T Farrar; Roy L Freeman; Louis P Garrison; Jennifer S Gewandter; Veeraindar Goli; Smriti Iyengar; Alejandro R Jadad; Mark P Jensen; Roderick Junor; Nathaniel P Katz; J Patrick Kesslak; Ernest A Kopecky; Dmitri Lissin; John D Markman; Michael P McDermott; Philip J Mease; Alec B O'Connor; Kushang V Patel; Srinivasa N Raja; Michael C Rowbotham; Cristina Sampaio; Jasvinder A Singh; Ilona Steigerwald; Vibeke Strand; Leslie A Tive; Jeffrey Tobias; Ajay D Wasan; Hilary D Wilson Journal: Pain Date: 2021-09-09 Impact factor: 7.926