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.
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Notes
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It is conceptually important to understand the difference between the share of the global clinical trial market and the accessibility to clinical trials: whereas share of clinical trials for each country is expressed as a global share of BPCT sites, accessibility is a population-adjusted parameter and refers to the number of BPCT sites per capita in the country relative to the US levels: take example of Bulgaria and the US: US has a 35% share of global clinical trial sites, while Bulgaria has only 0.8% of global market share, but number of industry-sponsored clinical trial sites adjusted per capita (relative to the US) shows US at a 100% and Bulgaria at 96%: i.e. an average Bulgarian has roughly the same chance to participate in an industry-sponsored clinical trial as an average US American. Take Egypt as another example: BPCT market share 0.1% of global BPCT sites, and the accessibility to clinical trials 0.6% of the US levels: i.e., an average Egyptian has ~200× lower accessibility to industry clinical trials relative to an average US American (data not shown).
References
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.
International Federation of Pharmaceutical Manufacturers & Associations. 2014. The pharmaceutical industry and global health, facts and figures 2014. Geneva.
Karlberg, J.P.E. 2009. Uninterrupted globalization of industry sponsored clinical trials. Clinical Trial Magnifier 2: 79–94.
———. 2010. WHO international clinical trials registry platform – an in-depth analysis. Clinical Trial Magnifier 3: 333–344.
———. 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.
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.
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.
Pineau, C. and C. Rink. 2013. Pharmaemerging markets – Picking a pathway to success. IMS Health White paper. Retrieved from: www.imshealth.com/pharmerging.
The World Bank. 2014. Data: Population, total [Data file]. Retrieved from http://data.worldbank.org/indicator/SP.POP.TOTL.
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.
UBS Investment Research. 2010. Global pharma: Doing well by doing good?, Q-Series: UBS World Pharma Model. Retrieved from: www.ubs.com/investmentresearch
Acknowledgement
Customized clinical trial analytics used in this paper were prepared and provided as a courtesy of LongTaal Institute (www.longtaal.com).
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Mišík, V., Boleček, M., Brady, R.V. (2017). Ethical Considerations of Industry-Sponsored Clinical Trials in the Arab Region. In: Silverman, H. (eds) Research Ethics in the Arab Region. Research Ethics Forum, vol 5. Springer, Cham. https://doi.org/10.1007/978-3-319-65266-5_14
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