Factors influencing decision-making in drug development and regulatory review

By William Chin, PhD, Scientific Coordinator, EUCRAF

What are the important issues that influence decision-making in the pharmaceutical industry and regulatory authorities? These are the questions being addressed in a study entitled "Factors influencing quality decision-making: regulatory and pharmaceutical industry perspectives" published online on the 28 January 2015 issue of the Pharmacoepidemiology and Drug Safety. In this study, 29 key opinion leaders from major regulatory authorities and the pharmaceutical industry were interviewed to identify key factors influencing quality decision-making. The authors reported 19 overaching themes influenced the way decisions are being made:

  • quality of data
  • validity of data
  • time considerations
  • organisational influences
  • cultural influences
  • analytical approach
  • logical approach
  • qualification and experience
  • subjective considerations
  • personal considerations
  • political influences
  • precedents for similar previous decisions
  • understanding of the decision in question
  • impact analyses
  • audit trail
  • education
  • awareness
  • individual versus corporate decision-making
  • frameworks

The authors reported a clear evidence of the presence of personal biases, different subjective styles, competence demands of decision-makers, organisational culture and other factors impacting the subjective decision-making approach of individuals, the culture and behaviour of the organisations in decision-making. Relationships between these themes were identified and integrated into a framework for quality decision-making.


1. Pharmacoepidemiol Drug Saf. 2015 Jan 28. doi: 10.1002/pds.3752. Factors influencing quality decision-making: regulatory and pharmaceutical industry perspectives. Donelan R1, Walker S, Salek S.