Why are emerging countries popular for clinical research?

Background. The business of clinical research has changed in the past two decades, shifting from industrialised Western countries to so-called emerging markets such as Eastern Europe, Latin America and Africa. An appraisal of the trends could identify associated factors that may have implications fo...

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Bibliographic Details
Published in:	South African medical journal Vol. 111; no. 5; pp. 453 - 459
Main Authors:	Strüver, V, Ibeneme, S.C
Format:	Journal Article
Language:	English
Published:	South Africa Health and Medical Publishing Group (HMPG) 01-05-2021 Health & Medical Publishing Group
Subjects:	Biomedical Research - economics Biomedical Research - legislation & jurisprudence Biomedical Research - trends Clinical trials Clinical Trials as Topic - economics Clinical Trials as Topic - legislation & jurisprudence Clinical Trials as Topic - statistics & numerical data Demographic aspects Developing countries Economic Development Health aspects Humans Internationality Location Nigeria South Africa Nigeria South Africa
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Summary:	Background. The business of clinical research has changed in the past two decades, shifting from industrialised Western countries to so-called emerging markets such as Eastern Europe, Latin America and Africa. An appraisal of the trends could identify associated factors that may have implications for the local populations and their endemic diseases.Objectives. To identify potential reasons why emerging countries have become attractive places for international sponsors to conduct their clinical trials.Methods. Using ClinicalTrials.gov, the Pan African Clinical Trials Registry, the National Health Research Database and the Nigeria Clinical Trials Registry, trend data on clinical research development were determined for two emerging African markets, Nigeria and South Africa (SA), from 2010 to 2018. Also, health data on the two countries from the fact sheets of health statistics of the World Health Organization were compared, as well as regulatory and ethical conditions. Available data were analysed using descriptive statistics and trend analysis.Results. The impact of globalisation is evident from the upward trend in clinical trials in SA before 2010, and the clear downward trend thereafter. One reason for this change could be the alignment of SA's regulatory and ethical frameworks with the Western world. In contrast, the upward trend is only just beginning in Nigeria, with the introduction of ethical/regulatory frameworks, and supportive institutions making the business of clinical research more attractive on an international level. Although the number of international and local sponsors increased in Nigeria from 2010 to 2018, only the latter increased in SA, with the former decreasing over the same period. Overall, there is a mismatch between country-specific diseases and the drugs being tested, to the extent that leprosy, which is endemic in Nigeria, and tuberculosis in SA were not in the list of top 10 study areas in either country.Conclusions. The globalisation trend is evident in the clinical trials business, but cannot be generalised to all emerging countries. Timing and intensity vary from country to country relative to factors that advance the existing profit-orientated business models of the sponsors. Furthermore, various diseases have been localised, which entails a diversely increasing need for research.
ISSN:	0256-9574 2078-5135
DOI:	10.7196/SAMJ.2021.v111i5.14870