Costs of Quality in Clinical Development

Area of Science:

• Pharmaceutical industry
• Clinical development
• Quality management

Background:

• Research and Development (R&D) costs in pharmaceuticals have doubled since the 1980s.
• There is an increasing focus on quality management and quality metrics within clinical development.
• Pharmaceutical companies view quality as a competitive advantage.

Purpose of the Study:

• To investigate whether costs of quality are tracked in clinical development.
• To confirm or reject the assumption that quality cost tracking is absent in this sector.

Main Methods:

• A survey was distributed to approximately 15 of the top 50 global pharmaceutical companies.
• Data collection focused on current practices in quality cost management within clinical trials.

Main Results:

• The tracking and analysis of costs of quality are not widespread in clinical development.
• Despite available tools and proven benefits in other industries, adoption is limited.
• Potential benefits include a reduction in overall quality costs.

Conclusions:

• There is a lack of literature and evidence for quality cost tracking in clinical development.
• The clinical research sector of the pharmaceutical industry appears resistant to adopting modern quality cost analysis methods.
• Implementing quality cost tracking is likely to help mitigate increasing R&D expenditures.