Standard of Care and Transparency in Clinical Trials Conducted in Developing Countries of Africa
Central African Journal of Public Health
Volume 5, Issue 2, April 2019, Pages: 92-97
Received: Aug. 30, 2018;
Accepted: Feb. 26, 2019;
Published: Mar. 28, 2019
Views 52 Downloads 18
Pia Mielczarek, Faculty III Information and Communication, Hochschule Hannover University of Applied Sciences and Arts, Hannover, Germany
Anna Streichhardt, Faculty III Information and Communication, Hochschule Hannover University of Applied Sciences and Arts, Hannover, Germany
Dnyanesh Limaye, Faculty III Information and Communication, Hochschule Hannover University of Applied Sciences and Arts, Hannover, Germany
Vaidehi Limaye, Faculty III Information and Communication, Hochschule Hannover University of Applied Sciences and Arts, Hannover, Germany
Firas Fneish, Faculty III Information and Communication, Hochschule Hannover University of Applied Sciences and Arts, Hannover, Germany; Institute of Biostatistics, Leibniz University Hannover, Hannover, Germany
Gerhard Fortwengel, Faculty III Information and Communication, Hochschule Hannover University of Applied Sciences and Arts, Hannover, Germany
Follow on us
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.
Developing Countries, Clinical Trials, Standard of Care, Transparency, Pharmaceutical Companies, Africa
To cite this article
Standard of Care and Transparency in Clinical Trials Conducted in Developing Countries of Africa, Central African Journal of Public Health.
Vol. 5, No. 2,
2019, pp. 92-97.
Copyright © 2019 Authors retain the copyright of this article.
This article is an open access article distributed under the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/
) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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.
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.
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.
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.
Maïgaa D, Akanmori BD, Chocarro L. Regulatory oversight of clinical trials in Africa: Progress over the past 5 years. Vaccine 2009; 27: 7249-7252.
Nardini C. The ethics of clinical trials. ecancer 2014; 8: 387 doi: 10.3332/ecancer.2014.387.
DESA: World Economic Situation and Prospects 2016. United Nations: United Nations publication, 2016.
©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/.
U.S. National Library of Medicine. ClinicalTrials.gov [Internet]. 2016. Available from: https://clinicaltrials.gov/ct2/home.
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.
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.
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.
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.
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.
Hawkins JS, Emanuel EJ: Exploitation and Developing Countries. The Ethics of Clinical Research. New Jersey: Princeton University Press, 2008.
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.