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Ethical Considerations of Industry-Sponsored Clinical Trials in the Arab Region

  • Vladimír Mišík
  • Martin Boleček
  • Rachel V. Brady
Chapter
Part of the Research Ethics Forum book series (REFF, volume 5)

Abstract

This paper evaluates latest geographic dynamics between 2009 and 2014 in biopharmaceutical clinical trials (BPCTs) and benchmarks accessibility to clinical trials in in the Arab region (Saudi Arabia, UAE, Egypt, Algeria, Kuwait, Oman, Qatar, Bahrain, Lebanon, Jordan, Morocco and Tunisia) against other global regions (# active BPCT sites/capita). In addition, this paper introduces, to our knowledge hitherto never previously published, benchmarks of participation of countries in development of new products (BPCT global market share), relative to the target level of consumption of developed pharmaceutical products (pharmaceutical consumption market share). Our findings imply a potential scientific and ethical challenge: under-representation of patients from Arab region in the development of novel pharmaceutical products relative to the consumption of the developed products. We will discuss the ethical implications for regions with low participation in development of new products and yet high consumption of developed products. We encourage that this mismatch between development and consumption of new drugs be addressed by governments, medical institutions and patient organizations in the Arab region, as well as biopharmaceutical companies planning to launch new products in these markets.

Keywords

Clinical trials Pharmaceutical development Pharmaceutical consumption Market share 

Notes

Acknowledgement

Customized clinical trial analytics used in this paper were prepared and provided as a courtesy of LongTaal Institute (www.longtaal.com).

References

  1. Godden, S., G. Ambler, and A.M. Pollack. 2010. Recruitment of minority ethnic groups into clinical cancer research trials to assess adherence to the principles of the Department of Health Research Governance Framework: National sources of data and general issues arising from a study in one hospital in England. Journal of Medical Ethics 36: 358–362.CrossRefGoogle Scholar
  2. International Federation of Pharmaceutical Manufacturers & Associations. 2014. The pharmaceutical industry and global health, facts and figures 2014. Geneva.Google Scholar
  3. Karlberg, J.P.E. 2009. Uninterrupted globalization of industry sponsored clinical trials. Clinical Trial Magnifier 2: 79–94.Google Scholar
  4. ———. 2010. WHO international clinical trials registry platform – an in-depth analysis. Clinical Trial Magnifier 3: 333–344.Google Scholar
  5. ———. 2014. Globalization of industry-sponsored, clinical trials. Latest insight on shifts in sites among regions. Clinical trial magnifier, 1–36. Falls Church: FDAnews. ISBN 978–1–60428-140-8.Google Scholar
  6. Misik, V., R.V. Brady, M. Bolecek, and H. Klech. 2014. Current trends in globalization of industry-sponsored clinical trials. Applied Clinical Research, Clinical Trials & Regulatory Affairs 1: 56–66.CrossRefGoogle Scholar
  7. Noor, A.M., D. Sarker, S. Vizor, B. McLennan, S. Hunter, A. Suder, H. Moller, J.F. Spicer, and S. Papa. 2013. Effect of patient socioeconomic status on access to early-phase cancer trials. Journal of Clinical Oncology 31 (2): 224–230.CrossRefGoogle Scholar
  8. Pineau, C. and C. Rink. 2013. Pharmaemerging markets – Picking a pathway to success. IMS Health White paper. Retrieved from: www.imshealth.com/pharmerging.
  9. The World Bank. 2014. Data: Population, total [Data file]. Retrieved from http://data.worldbank.org/indicator/SP.POP.TOTL.
  10. Thiers, F.A., A.J. Sinskey, and E.R. Berndt. 2008. Trends in the globalization of clinical trials. Nature Reviews: Drug Discovery 7: 13–14.Google Scholar
  11. UBS Investment Research. 2010. Global pharma: Doing well by doing good?, Q-Series: UBS World Pharma Model. Retrieved from: www.ubs.com/investmentresearch

Copyright information

© Springer International Publishing AG 2017

Authors and Affiliations

  • Vladimír Mišík
    • 1
  • Martin Boleček
    • 2
  • Rachel V. Brady
    • 2
  1. 1.LongTaal, Clinical Trial AnalyticsBratislavaSlovakia
  2. 2.QuintilesIMSViennaAustria

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