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Standard of Care and Transparency in Clinical Trials Conducted in Developing Countries of Africa

Received: 30 August 2018     Accepted: 26 February 2019     Published: 28 March 2019
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Abstract

Background: Clinical trials are conducted all over the world, including developing economies in Africa. Pharmaceutical companies could easily take advantage of the regulatory situation in these vulnerable countries. This research study examines ethical statements of the 25 top pharmaceutical companies conducting clinical trials in Africa regarding three questions in objectives according to their policies or their websites. Objectives: 1. Do pharmaceutical companies mention clinical trials in developing countries? 2. Do pharmaceutical companies mention the issue with standard of care? 3. Do pharmaceutical companies mention NDA (New Drug Application) and special prices for countries and participants? Methods: To evaluate the statements found in their policies or websites, a rating scale with a maximum of 10 points was developed. The statements of the pharmaceutical companies have been rated by at least two independent researchers. High points are equal to high standards, the maximum points were 10. Results: Only 15 out of the biggest 25 pharmaceutical companies were conducting at least 10 clinical trials in developing countries in Africa during the last five years. On average, the pharmaceutical companies achieved a score of 6.93 of 10. Conclusion: On one hand, the result shows that some companies achieved high scores. On the other hand, it shows that some companies need to improve their policies and statements of commitment to serve as a role model.

Published in Central African Journal of Public Health (Volume 5, Issue 2)
DOI 10.11648/j.cajph.20190502.15
Page(s) 92-97
Creative Commons

This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.

Copyright

Copyright © The Author(s), 2019. Published by Science Publishing Group

Keywords

Developing Countries, Clinical Trials, Standard of Care, Transparency, Pharmaceutical Companies, Africa

References
[1] Nallamothu BK, Hayward RA, Bates ER. Beyond the randomized clinical trial: the role of effectiveness studies in evaluating cardiovascular therapies. Circulation. 2008; 118: 1294–303.
[2] Weijer C, Shapiro SH, Glass KC. Clinical equipoise and not the uncertainty principle is the moral underpinning of the randomised controlled trial. BMJ 2000; 321 (7263): 756-758.
[3] Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington RA, Califf RM, et al. Ethical and Scientific Implications of the Globalization of Clinical Research. N Engl J Med 2009; 360: 816-823.
[4] Puppalwar G, Mourya M, Kadhe G, Mane A. Conducting clinical trials in emerging markets of sub-Saharan Africa: review of guidelines and resources for foreign sponsors. Open Access Journal of Clinical Trials 2015; 2015 (7): 23-34.
[5] Maïgaa D, Akanmori BD, Chocarro L. Regulatory oversight of clinical trials in Africa: Progress over the past 5 years. Vaccine 2009; 27: 7249-7252.
[6] Nardini C. The ethics of clinical trials. ecancer 2014; 8: 387 doi: 10.3332/ecancer.2014.387.
[7] DESA: World Economic Situation and Prospects 2016. United Nations: United Nations publication, 2016.
[8] ©Statista 2016. Top 50 Pharmaunternehmen weltweit nach Umsatz und Ausgaben für Forschung und Entwicklung im Jahr 2015 (in Milliarden US-Dollar) [Internet]. 2015. Available from: https://de.statista.com/statistik/daten/studie/439880/umfrage/top-50-pharmaunternehmen-umsatz-und-forschungsausgaben/.
[9] U.S. National Library of Medicine. ClinicalTrials.gov [Internet]. 2016. Available from: https://clinicaltrials.gov/ct2/home.
[10] Boehringer Ingelheim GmbH. Corporate Public Affairs. For Better Health. Access to Healthcare at Boehringer Ingelheim [Internet]. 2015. Available from: https://www.boehringer-ingelheim.com/sites/default/files/Documents/ForBetterHealth.pdf.
[11] Emanuel EJ, Wendler D, Killen J, Grady C. What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research. JID 2004; 189: 930-937.
[12] El Setouhy M, Agbenyega T, Anto F, Clerk CA, Koram KA, English M, et al. Fair Benefits for Research in Developing Countries. SCIENCE 2002; 298: 2133-2134.
[13] Hyder AA, Dawson L. Defining standard of care in the developing world: The intersection of international research ethics and health systems analysis. Developing World Bioethics. 2005; 5 (2): 1471-8847.
[14] Lie RK, Emanuel EJ, Grady C, Wendler D. The standard of care debate: the Declaration of Helsinki versus the international consensus opinion. J Med Ethics 2004; 30: 190-193.
[15] Hawkins JS, Emanuel EJ: Exploitation and Developing Countries. The Ethics of Clinical Research. New Jersey: Princeton University Press, 2008.
[16] Boseley S. Big Pharma ups its game in providing drugs to people in poor countries. Access to Medicines Index shows pharmaceutical companies improving on pricing, neglected diseases, lobbying and trials. theguardian [Internet]. 2012. Available from: https://www.theguardian.com/global-development/2012/nov/28/big-pharma-drugs-poor-countries.
Cite This Article
  • APA Style

    Pia Mielczarek, Anna Streichhardt, Dnyanesh Limaye, Vaidehi Limaye, Firas Fneish, et al. (2019). Standard of Care and Transparency in Clinical Trials Conducted in Developing Countries of Africa. Central African Journal of Public Health, 5(2), 92-97. https://doi.org/10.11648/j.cajph.20190502.15

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    ACS Style

    Pia Mielczarek; Anna Streichhardt; Dnyanesh Limaye; Vaidehi Limaye; Firas Fneish, et al. Standard of Care and Transparency in Clinical Trials Conducted in Developing Countries of Africa. Cent. Afr. J. Public Health 2019, 5(2), 92-97. doi: 10.11648/j.cajph.20190502.15

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    AMA Style

    Pia Mielczarek, Anna Streichhardt, Dnyanesh Limaye, Vaidehi Limaye, Firas Fneish, et al. Standard of Care and Transparency in Clinical Trials Conducted in Developing Countries of Africa. Cent Afr J Public Health. 2019;5(2):92-97. doi: 10.11648/j.cajph.20190502.15

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  • @article{10.11648/j.cajph.20190502.15,
      author = {Pia Mielczarek and Anna Streichhardt and Dnyanesh Limaye and Vaidehi Limaye and Firas Fneish and Gerhard Fortwengel},
      title = {Standard of Care and Transparency in Clinical Trials Conducted in Developing Countries of Africa},
      journal = {Central African Journal of Public Health},
      volume = {5},
      number = {2},
      pages = {92-97},
      doi = {10.11648/j.cajph.20190502.15},
      url = {https://doi.org/10.11648/j.cajph.20190502.15},
      eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.cajph.20190502.15},
      abstract = {Background: Clinical trials are conducted all over the world, including developing economies in Africa. Pharmaceutical companies could easily take advantage of the regulatory situation in these vulnerable countries. This research study examines ethical statements of the 25 top pharmaceutical companies conducting clinical trials in Africa regarding three questions in objectives according to their policies or their websites. Objectives: 1. Do pharmaceutical companies mention clinical trials in developing countries? 2. Do pharmaceutical companies mention the issue with standard of care? 3. Do pharmaceutical companies mention NDA (New Drug Application) and special prices for countries and participants? Methods: To evaluate the statements found in their policies or websites, a rating scale with a maximum of 10 points was developed. The statements of the pharmaceutical companies have been rated by at least two independent researchers. High points are equal to high standards, the maximum points were 10. Results: Only 15 out of the biggest 25 pharmaceutical companies were conducting at least 10 clinical trials in developing countries in Africa during the last five years. On average, the pharmaceutical companies achieved a score of 6.93 of 10. Conclusion: On one hand, the result shows that some companies achieved high scores. On the other hand, it shows that some companies need to improve their policies and statements of commitment to serve as a role model.},
     year = {2019}
    }
    

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  • TY  - JOUR
    T1  - Standard of Care and Transparency in Clinical Trials Conducted in Developing Countries of Africa
    AU  - Pia Mielczarek
    AU  - Anna Streichhardt
    AU  - Dnyanesh Limaye
    AU  - Vaidehi Limaye
    AU  - Firas Fneish
    AU  - Gerhard Fortwengel
    Y1  - 2019/03/28
    PY  - 2019
    N1  - https://doi.org/10.11648/j.cajph.20190502.15
    DO  - 10.11648/j.cajph.20190502.15
    T2  - Central African Journal of Public Health
    JF  - Central African Journal of Public Health
    JO  - Central African Journal of Public Health
    SP  - 92
    EP  - 97
    PB  - Science Publishing Group
    SN  - 2575-5781
    UR  - https://doi.org/10.11648/j.cajph.20190502.15
    AB  - Background: Clinical trials are conducted all over the world, including developing economies in Africa. Pharmaceutical companies could easily take advantage of the regulatory situation in these vulnerable countries. This research study examines ethical statements of the 25 top pharmaceutical companies conducting clinical trials in Africa regarding three questions in objectives according to their policies or their websites. Objectives: 1. Do pharmaceutical companies mention clinical trials in developing countries? 2. Do pharmaceutical companies mention the issue with standard of care? 3. Do pharmaceutical companies mention NDA (New Drug Application) and special prices for countries and participants? Methods: To evaluate the statements found in their policies or websites, a rating scale with a maximum of 10 points was developed. The statements of the pharmaceutical companies have been rated by at least two independent researchers. High points are equal to high standards, the maximum points were 10. Results: Only 15 out of the biggest 25 pharmaceutical companies were conducting at least 10 clinical trials in developing countries in Africa during the last five years. On average, the pharmaceutical companies achieved a score of 6.93 of 10. Conclusion: On one hand, the result shows that some companies achieved high scores. On the other hand, it shows that some companies need to improve their policies and statements of commitment to serve as a role model.
    VL  - 5
    IS  - 2
    ER  - 

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Author Information
  • Faculty III Information and Communication, Hochschule Hannover University of Applied Sciences and Arts, Hannover, Germany

  • Faculty III Information and Communication, Hochschule Hannover University of Applied Sciences and Arts, Hannover, Germany

  • Faculty III Information and Communication, Hochschule Hannover University of Applied Sciences and Arts, Hannover, Germany

  • Faculty III Information and Communication, Hochschule Hannover University of Applied Sciences and Arts, Hannover, Germany

  • Faculty III Information and Communication, Hochschule Hannover University of Applied Sciences and Arts, Hannover, Germany

  • Faculty III Information and Communication, Hochschule Hannover University of Applied Sciences and Arts, Hannover, Germany

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