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 |
Developing Countries, Clinical Trials, Standard of Care, Transparency, Pharmaceutical Companies, Africa
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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
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
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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Download@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}
}
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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