Decision-making per se can be regarded as part art and part science in the development of new medicines. In the area of pharmaceutical development, decision-making plays a pivotal role in the continuation or the termination of further development or withdrawal of medicinal products. The decisions made at each stage have a direct impact on all stakeholders namely, pharmaceutical companies, regulators, payers and patients. What is lacking at present is a qualified understanding of the subjective decision-making approach, influences, behaviours and other factors which impact the decision-making of individuals and organisations involved in the delivery of new medicines. The aim of this study was, therefore, to develop and validate a generic instrument for appraising the quality of decision-making. Semi-structured interviews were carried out with 29 key decision-makers from the pharmaceutical industry, regulatory authorities and contract research organisations (CROs). They were invited to discuss all aspects, including their perception of decision-making and its role in drug development and regulatory review; decision making within their organisation; awareness and use of decision-making techniques; and impact and monitoring of decisions. Thematic analysis was carried out using NViVO 8 © software. A preliminary 94-item instrument was developed from the themes and the sub-themes that emerged from the interviews. Content validity was assessed using qualitative and quantitative data from an expert panel involving six key decision makers. A separate international cohort of 120 individuals working in the pharmaceutical industry, regulatory authority or CROs was recruited for factor analysis to reduce items. A further 78 individuals completed the final version of the QoDOS for construct validity and reliability. Most individuals interviewed were male (55% - n=16) and their level of experience ranged from 7 to 35 years. 32 themes and 90 sub-themes of aspects of decision-making were identified from the interviews. The median numbers of themes reported by experts was 6 (range = 1-10). The key themes included: quality and validity of the data; vii political, financial, competitor and reward influences; analytical and logical approach; overconfidence in own judgement; plunging in or procrastinating with decision-making; impact analysis of decisions; education and awareness of evolving decision-making techniques; and SWOT and alternate outcome planning. Relationships between the themes were identified. A 94-item generic instrument for assessing the quality of life decision-making, Quality of Decision-Making Orientation Scheme (QoDOS) ©, with a 5-point Likert response scale was developed. The content validity panel’s rating of each item on a 4-point scale for the 4 attributes showed “strongly agreed” or “agreed” (88%) with an ICC value of .89 (CI = 0.56 – 0.99) suggesting a high agreement between the panel members’ responses. This led to the reduction of 20 items and addition of two items as a result of cross-referencing with the qualitative data. Thus, the 76 items (version 2) emerged from content validation. Factor analysis produced a 47-item measure with four factors. The QoDOS showed high internal consistency (n = 120, Cronbach’s alpha = 0.89), high reproducibility (n = 20, ICC = 0.77) and a mean completion time of 10 minutes. 10 hallmarks of “Good Decision-Making Practice” (GDMP) were identified. The QoDOS is a valuable addition to the decision-making tool box of drug developers and regulators and has the potential to fill the missing gap of the entire process which is building quality into the lifecycle of medicine. The identification of ten hallmarks and generation of a framework for GDMP are also important contributions of this study to the field.
| Identifer | oai:union.ndltd.org:bl.uk/oai:ethos.bl.uk:600589 |
| Date | January 2013 |
| Creators | Donelan, Ronan |
| Publisher | Cardiff University |
| Source Sets | Ethos UK |
| Detected Language | English |
| Type | Electronic Thesis or Dissertation |
| Source | http://orca.cf.ac.uk/59185/ |
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