Costs of Quality in Clinical Development

Background: The basis for this article is an individual project during a Master of Science program at Cranfield University, UK. Research and development (R&D) costs in the pharmaceutical industry have increased at a rate where costs have doubled compared to previous decades since the 1980s. In parallel, during recent years, there has been an increased focus on quality management within clinical development. Furthermore, pharma companies are talking about quality as a competitive advantage with an increased focus on quality metrics. The objective of this research was to confirm/reject the assumption that costs of quality are not being tracked within clinical development. Methods: The key component of this research consists of a survey that was sent out to approximately 15 of the top 50 global pharmaceutical companies. Results: The research showed that the praxis of tracking and analyzing costs of quality was not widespread within clinical development, although the tools are available and experience from other industries showed that there are potential benefits to be realized, including a reduction of total quality costs. Conclusions: Even though tools for analyzing costs of quality have been available since the 1950s, there is little evidence in the literature that quality costs are being tracked and analyzed in clinical development. On the contrary, there are examples that the clinical research part of the pharma industry is stuck in traditional ways of working. However, it is likely that tracking and analyzing costs of quality can help limit the increase of R&D costs.