Edinburgh Napier University

  The central aim of this thesis is to investigate how physicians, working for Pharmaceutical Product Development (PPD), a clinical research organisation (CRO), make decisions for a new industry standard for good clinical practice in medical device trials. This topic is introduced via review of decision theory and decision-making (DM) in contextual environments. Physician’s career experiences, insights and perceptions of how they make regulatory compliance decisions, and how they think these new requirements should be met, are explored in the main study.
The research rationale relates to the author’s experience of physician DM in non-medical settings during 25 years working in the field, with a desire to ascertain how compliance influences are identified, assessed and synthesized into decisions within the workplace. Furthermore PPD physicians hold senior positions and new industry regulations require regulatory compliance decisions to be made at the highest level.
In this study an interpretive phenomenological paradigm was used to ascertain how physicians make sense of industry regulation then make compliance decisions based on their roles, experiences, cues and sources of data available. Literature review identified 4 core themes (decision-making, errors, situation awareness and new requirements) that guided qualitative data collection via 2 mini-focus groups (n=3 per group) and semi-structured interviews (n=12). Review of 18 physicians’ data occurred via framework analysis then comparing between contrasting positions presented. The findings found 4-5 dimensions under each core theme from which 2 frameworks were constructed: firstly, using DM tenets to guide physicians’ DM in context and, secondly, identifying how to comply with new industry requirements.
This research contributes to academia and practice via framework generation for DM in context. It is unique in its contextual exploration, analysis and interpretation of physicians’ impressions, from departmental heads to company board members, in relation to their everyday working lives and the decision approaches used to ensure regulatory compliance within their organisational area of responsibility. The thesis ends by considering potential areas for further research such as deploying each framework, applying the framework concepts with other industry legislation changes or exploring alternative research paradigms in PPD.