Document Type : Original Article
1 Research Institute on Sustainable Economic Growth, National Research Council of Italy, Moncalieri, Italy
2 Department of Management, University of Turin, Turin, Italy
Background: Clinical research is a specific phase of the production process in the pharmaceutical industry in which companies test candidate drugs on patients in order to collect clinical evidence about safety and effectiveness.
Objective: This paper is an operational research which aimed to support the hypothesis that pharmaceutical clinical research is like any other production process which could be localized where the cost is most competitive. In other words, this work aimed to demonstrate that the localization process of this specific phase of the pharmaceutical industry’s R&D is based on the price of clinical evidence.
Methods: Considering Europe and taking panel data into account, an efficiency frontier through data envelopment analysis (DEA) was estimated. The efficiency of countries in maximizing the number of innovative medical treatments, given their available resources was estimated. Afterwards, focusing on European macro-regions, authors analyzed whether a significant concentration of clinical research exists.
Results: Results suggest that, taking the expected principal investigators’ fee into account, Southeastern Europe and Central Eastern Europe are the most attractive macro-regions for the pharmaceutical industry’s foreign direct investments in clinical research.
Conclusion: The results of the proposed operational research cannot reject the suggested evolution of the pharmaceutical industry’s clinical research. In other words, results confirm the localization process of the testing phase in East Europe, where the expected principal investigators’ fee is more competitive.
- Ippoliti R. Human experimentation. In: Encyclopedia of Law and Economics. New York: Springer; 2016:1-3. doi:10.1007/978-1-4614-7883-6_237-1.
- Ippoliti R. Institutional Review Board. In: Encyclopedia of Law and Economics. New York: Springer; 2015:1-4. doi:10.1007/978-1-4614-7883-6_197-1.
- Ippoliti R. The market of human experimentation. European Journal of Law and Economics. 2010;35(1):61-85.
- Ippoliti R. Economic efficiency of countries’ clinical review processes and competitiveness on the market of human experimentation. Value Health. 2013;16(1):148-154. doi:10.1016/j.jval.2012.09.010.
- Ippoliti R, Falavigna G. Public health institutions, clinical research and protection system of patients’ rights: an impact evaluation of public policy. Public Organ Rev. 2012;14(2):109-125. doi:10.1007/s11115-012-0208-5.
- Adobor H. Ethical issues in outsourcing: the case of contract medical research and the global pharmaceutical industry. J Bus Ethics. 2011;105(2):239-255.
- Santiago-Rodriguez F. Facing the trial of internationalizing clinical trials to developing counties: with some evidence from Mexico. Working Paper Series. United Nations University, Maastricht, The Netherlands; 2008:1-26.
- Jia H. Chinese manufacturers vie for piece of outsourcing pie. Nat Biotechnol. 2007;25(12):1337-1338. doi:10.1038/nbt1207-1337.
- Ippoliti R. Clinical research, an empirical work on the European market of human experimentation. J Public Health. 2011;20(4):461-475. doi:10.1007/s10389-011-0472-9.
- Cook W, Seiford L. Data envelopment analysis (DEA) – Thirty years on. Eur J Oper Res. 2009;192(1):1-17.
- Charnes A, Cooper W, Rhodes E. Measuring the efficiency of decision making units. Eur J Oper Res. 1978;2(6):429-444.
- Fare R. Intertemporal Production Frontiers. 1st ed. Boston: Springer; 2012.
- Coelli TJ, O‘Donnell CJ, Rao DSP. An Introduction to Efficicency and Productivity Analysis. 1st ed. Springer; 2005.
- Fethi M, Pasiouras F. Assessing bank efficiency and performance with operational research and artificial intelligence techniques: A survey. Eur J Oper Res. 2010;204(2):189-198. doi:10.1016/j.ejor.2009.08.003.
- Ray S, Das A. Distribution of cost and profit efficiency: evidence from Indian banking. Eur J Oper Res. 2010;201(1):297-307.
- Hung S, Lu W, Wang T. Benchmarking the operating efficiency of Asia container ports. Eur J Oper Res. 2010;203(3):706-713. doi:10.1016/j.ejor.2009.09.005
- Barros C, Nektarios M, Assaf A. Efficiency in the Greek insurance industry. Eur J Oper Res. 2010;205(2):431-436. doi:10.1016/j.ejor.2010.01.011
- Chen A, Hwang Y, Shao B. Measurement and sources of overall and input inefficiencies: evidences and implications in hospital services. Eur J Oper Res. 2005;161(2):447-468. doi:10.1016/j.ejor.2003.09.017.
- Dlouhy M, Jablonsky J, Novosadova I. Use of data envelopment analysis for efficiency evaluation of Czech hospitals. Politicka Ekonomie. 2007:55:60-71.
- Pulina M, Detotto C, Paba A. An investigation into the relationship between size and efficiency of the Italian hospitality sector: a window DEA approach. Eur J Oper Res. 2010;204:613-620. doi:10.1016/j.ejor.2009.11.006.
- Piacenza M, Turati G, Vannoni D. Restructuring hospital industry to control public health care expenditure: the role of input substitutability. Econ Model. 2010;27(4):881-890. doi:10.1016/j.econmod.2009.10.006.
- Garavaglia G, Lettieri E, Agasisti T, Lopez S. Efficiency and quality of care in nursing homes: an Italian case study. Health Care Manag Sci. 2011;14(1):22-35. doi:10.1007/s10729-010-9139-2.
- Ippoliti R, Falavigna G. Efficiency of medical care industry: evidence from the Italian regional system. Eur J Oper Res. 2012;217:643-652. doi:10.1016/j.ejor.2011.10.010.
- Rezaei S, Dopeykar N, Barouni M, Jafari M, Gharibi F. Do hospitals affiliated with the kurdistan university of medical sciences perform efficiently? Non-parametric data envelopment analysis. Hospital Practices and Research. 2016;1(4):135-140.
- Farrell MJ. The measurement of productive efficiency. J R Stat Soc Series A. 1957;120(3):253-290.
- Banker RD, Charnes A, Cooper WW. Some models for estimating technical and scale inefficiencies in data envelopment analysis. Manage Sci. 1984;30(9):1078-1092.
- Cooper WW, Seidorf LM, Tone K. Data Envelopment Analysis. A Comprehensive Text With Models, Application References and DEA-Solver Software. 2nd ed. Berlin: Springer; 2007.
- Simar L, Wilson PW. Estimation and inference in two-stage, semi-parametric models of production processes. J Econom. 2007;136:31-64. doi:10.1016/j.jeconom.2005.07.009.
- Hudson R. Changing industrial production systems and regional development in the new Europe. Trans Inst Br Geogr. 2002;27(3):262-281.
- Carstensen K, Toubal F. Foreign direct investment in Central and Eastern European countries: a dynamic panel analysis. J Comp Econ. 2004;32:3-22.
- Bevan A, Estrin S. The determinants of foreign direct investment into European transition economies. J Comp Econ. 2004;32:775-787.
- Suits DB. Use of dummy variables in regression equations. J Am Stat Assoc. 1957;52(280):548-551.
- Gelber RD, Goldhirsch A. Can a clinical trial be the treatment of choice for patients with cancer? J Natl Cancer Inst. 1988;80:886-887.
- Peppercorn J, Weeks JC, Cook EF, Joffe S. Comparison of outcomes in cancer patients treated within and outside clinical trials: conceptual framework and structured review. Lancet. 2004;363:263-270. doi:10.1016/S0140-6736(03)15383-4.
- Bredin C, Eliasziw M, Syme R. Drug cost avoidance resulting from cancer clinical trials. Contemp Clin Trials. 2010;31(6):524-529. doi:10.1016/j.cct.2010.09.004.
- Shen LJ, Chou H, Huang CF, Chou GM, Chan WK, Wu FL. Economic benefits of sponsored clinical trials on pharmaceutical expenditures at a medical center in Taiwan. Contemp Clin Trials. 2011;2(4):485-491. doi:10.1016/j.cct.2011.04.003.
- Rogers S.D., Lampasona V., Buchanan E.C The financial impact of investigational drug services. Top Hosp Pharm Manage. 1994;14(1):60-6.
- McDonagh MS, Miller SA, Naden E. Costs and savings of investigational drug services. Am J Health Syst Pharm. 2000;57:40–43.
- Jönsson B, Wilking N. The burden and cost of cancer. Ann Oncol. 2007;18(3):iii9–22.
- Koenig P, MacGarvie M. Regulatory policy and the location of bio-pharmaceutical foreign direct investment in Europe. J Health Econ. 2011;30(5):950-965. doi:10.1016/j.jhealeco.2011.07.005.