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Costs of Quality in Clinical Development

  • Regulatory Science: Original Article
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Abstract

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.

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References

  1. Eudralex, vol 4. Pharmaceutical quality system. EU guidelines to good manufacturing practice medicinal products for human and veterinary use. European Commission Health and Consumers Directorate-General. http://ec.europa.eu/health/files/eudralex/vol-4/vol4-chap1_2013-01_en.pdf. Published 2013. Accessed August 23, 2016.

  2. GVP, module 1. Guideline on good pharmacovigilance practices (GVP). Module I: Pharmacovigilance systems and their quality systems. European Medicines Agency. 2012.

  3. Al-Dujaili MAA. Study of the relation between types of the quality costs and its impact on productivity and costs: verification in manufacturing industries. Total Quality Management and Business Excellence. 2013;24(4):397–419.

    Article  Google Scholar 

  4. Carpinetti LCR, Buosi T, Gerolamo MC. Quality management and Improvement: a framework and a business-process reference model. Business Process Manage. 2003;9(4):543-554.

    Article  Google Scholar 

  5. Dahlgaard JJ, Kristensen K, Kanji GK. Quality costs and total quality management. Total Quality Management. 1992;3(3): 211–221.

    Article  Google Scholar 

  6. Fassoula ED. Reverse logistics as a means of reducing the cost of quality. Total Quality Management. 2005;16(5):631–643.

    Article  Google Scholar 

  7. Freeman JM. The case for quality costing simulation. TQM J. 2008;20(5):476–487.

    Article  Google Scholar 

  8. Kadjan V. Why quality, cost and business excellence are inseparable. Total Quality Management. 2007;18(1–2):147–152.

    Article  Google Scholar 

  9. Malik TM, Khalid R, Zulqarnain A, Iqbal SA. Cost of quality: findings of a wood products manufacturer. TQM J. 2016;28(1): 2–20.

    Article  Google Scholar 

  10. Srivastava SK. Towards estimating cost of quality in supply chains. Total Quality Management & Business Excellence 2008; 19(3):193–208.

    Article  Google Scholar 

  11. Power S. Considerations to design and implementation of metrics to improve quality within pharmaceutical industry. M.Sc. Thesis, Cranfield University.

  12. FDA Guidance for Industry. Oversight of clinical investigations—a risk-based approach to monitoring. https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm269919.pdf. Accessed March 12, 2017.

  13. ICH E6 (R2) (2016). Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

  14. Meeker-O’Connell A, Sam LM, Bergamo N, Little JA. TransCelerate’s clinical quality management system: from a vision to a conceptual framework. Therapeutic Innovation & Regulatory Science. 2016;50(4):397–413.

    Article  Google Scholar 

  15. Lörstad M. Data quality of the clinical trial process—costly regulatory compliance at the expense of scientific proficiency. Quality Assurance J. 2004;8:177–182.

    Article  Google Scholar 

  16. MHRA Guidance, Good Clinical Practice for Clinical Trials, published 18th December 2014. https://www.gov.uk/good-clinical-practice-for-clinical-trials. Accessed February 1, 2017.

  17. Tufts CSDD.Outlook 2015. Tufts Center for the Study of Drug Development, Tufts University. http://csdd.tufts.edu/files/uploads/Outlook-2015.pdf. Published 2015. Accessed April 9, 2017.

  18. Deloitte LLP. Balancing the R&D equation—Measuring the return from pharmaceutical innovation 2016. Deloitte Centre for Health Solutions. https://www2.deloitte.com/uk/en/pages/life-sciences-and-healthcare/articles/measuring-return-from-pharmaceutical-innovation.html. Published 2016. Accessed April 9, 2017.

  19. Eisenstein EL, Collins R, Cracknell BS, et al. Sensible approaches for reducing clinical trial costs. Clin Trials. 2008;5:75–84.

    Article  Google Scholar 

  20. Paul SM, Mytelka DS, Dunwiddie CT, et al. How to improve R&D productivity: the pharmaceutical industry’s grand challenge. Nat Rev Drug Discov. 2010;9(3):203–214.

    Article  CAS  Google Scholar 

  21. DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ. 2003; 22:151–185.

    Article  Google Scholar 

  22. Castillo-Villar KK, Smith NR, Simonton JL. The impact of the cost of quality on serial supply-chain network design. Int J Product Res. 2012;50(19)5544–5566.

    Article  Google Scholar 

  23. Chiadamrong N. The development of an economic quality cost model. Total Quality Management and Business Excellence 2003; 14(9):999–1014.

    Article  Google Scholar 

  24. Holota T, Hrubec J, Kotus M, Holienčinová M, Čapošová E. The management of quality costs analysis model. Serbian J Manage. 2016;11(1):119–127.

    Article  Google Scholar 

  25. Freiesleben J. The economic effects of quality improvement. Total Quality Management and Business Excellence 2005; 16(7):915–922.

    Article  Google Scholar 

  26. Hwang GH, Aspinwall EM. Quality cost models and their application: a review. Total Quality Management. 1996;7(3):267–281.

    Article  Google Scholar 

  27. Feigenbaum AV. Total quality control. Harvard Business Rev. 1956;34:93–101.

    Google Scholar 

  28. Miller RL, Cangemi JP. Why total quality management fails: perspective of top management. J Manage Dev. 1993;12(7):40.

    Article  Google Scholar 

  29. Johnston A, Ozment J. A firm-specific analysis of service quality costs. International Journal of Logistics. 2015;18(5): 387–401.

    Article  Google Scholar 

  30. Getz KA, Zuckerman R, Cropp AB, Hindle AL, Krauss R, Kaitin KI. Measuring the incidence, causes, and repercussions of protocol amendments. Drug Informa J. 2011;45:265–275.

    Article  Google Scholar 

  31. Wise P, Drury M. Pharmaceutical trials in general practice: the first 100 protocols. An audit by the clinical research ethics committee of the Royal College of General Practitioners. Br Med J. 1996;313:1245–1248.

    Article  CAS  Google Scholar 

  32. Lösch C, Neuhäuser M. The statistical analysis of a clinical trial when a protocol amendment changed the inclusion criteria. BMC Med Res Methodol. 2008;8:16.

    Article  Google Scholar 

  33. Tufts Center for the Study of Drug Development. Protocol amendments improve elements of clinical trial feasibility, but at high economic and cycle time cost [press release]. Tufts Center for the Study of Drug Development, Tufts University. http://csdd.tufts.edu/news/complete_story/pr_ir_jan_feb_2016. Published 2016. Accessed October 2, 2016.

  34. Clinical Trials Transformation Initiative. CTTI Quality by Design Project—Critical to Quality (CTQ) factors principles document. https://www.ctti-clinicaltrials.org/files/principles_document_finaldraft_19may15_1.pdf. Published 2015. Accessed March 16, 2017.

  35. Porter LJ, Rayner P. Quality costing for total quality management. Int J Product Econ. 1992;27:69–81.

    Article  Google Scholar 

  36. Aoieong RT, Tang SL, Ahmed SM. A process approach in measuring quality costs of construction projects: model development. Construction Manage Econ. 2002;20:179–192.

    Article  Google Scholar 

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Authors and Affiliations

  1. AstraZeneca, Mölndal, 43183, Sweden

    Bolennart Eriksson MSc

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  1. Bolennart Eriksson MSc
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Correspondence to Bolennart Eriksson MSc.

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Eriksson, B. Costs of Quality in Clinical Development. Ther Innov Regul Sci 53, 706–713 (2019). https://doi.org/10.1177/2168479018809693

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