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Conducting clinical trials in emerging markets of sub-Saharan Africa: review of guidelines and resources for foreign sponsors

Authors Puppalwar G, Mourya M, Kadhe G, Mane A

Received 10 November 2014

Accepted for publication 7 January 2015

Published 24 March 2015 Volume 2015:7 Pages 23—34

DOI https://doi.org/10.2147/OAJCT.S77316

Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 2

Editor who approved publication: Professor Greg Martin

Gaurav Puppalwar, Meenakshi Mourya, Ganesh Kadhe, Amey Mane

Medical Affairs, Wockhardt Limited, Wockhardt Towers, Bandra Kurla Complex, Mumbai, India

Abstract: Clinical trials provide a foundation for new drug development processes, as well as for product license extensions for existing therapies. The reduction in the amount of time and cost to conduct a clinical trial becomes important, as competition to bring a new drug to the market is increasing, and so is the search for new markets. Kenya, Nigeria, Tanzania, Uganda, and Zambia offer a diverse patient population, as well as a comparatively research-friendly and ambitious government to develop these countries as pharmaceutical and health sectors of excellence. All these countries have their own guidelines to conduct clinical trials that feature some similarities and some subtle differences. Over the last decade, the guidelines have been evolving to provide a good ground to foreign sponsors, which carry out clinical trials while keeping the interest of patients as a priority. In the advent of these evolving guidelines, it becomes important for a foreign sponsor to understand and be aware of these guidelines before carrying out clinical trials. The present paper attempts to collect and compile all information available regarding the guidelines on the conduct of trials by a foreign sponsor in these five countries, which are available at government websites and search engines. The information gathered was organized into simplified flowcharts for easy understanding and usage. A clear understanding of the guidelines can effectively reduce the challenges faced for conducting clinical trials in these countries.

Keywords: informed consent, ethics, drug development, emerging markets

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