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

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.