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Patient Benefit of Clinical Research in Diversely Advanced African Developing Countries

  • Background: The globalization of clinical research should also benefit the population in developing markets. In this context, the approval of tested medicines and the associated expansion of medical care beyond clinical studies would be desirable as a possible long-term benefit. Objectives: This study was designed to compare the development of the number of clinical trials with the number of marketing authorizations of medicines on the African continent. To contrast these 2 parameters, the data were analyzed using the model of an ecological study. Methods: To reflect the broad spectrum of African developing countries with diverse levels of development, the data collection was based on 2 geographically selected sample countries each from Central, North, East, West, and Southern Africa. Based on the ClinicalTrials.gov registry, the first step was to collect trends data on the development of the clinical trials in the 10 selected countries of the country list of the African Region published by the World Health Organization for the period 2015 to 2018. Subsequently, data on the current number of marketing authorizations of medicines in the selected sample countries were identified using the online registries of the national authorities. The data were utilized in comparative analyses. Results: Eight out of 10 model countries showed an increase in the number of clinical trials, with the exceptions of Cameroon and Libya, which showed an overall decline in research activity over the entire time. In direct comparison with drug registrations, the numbers indicate a similar development. The only exception here is Nigeria, a country with a solid performance in clinical research and yet a decrease in medicine registrations since 2015. Conclusions: The expected increase in the development of clinical research as result of the globalization trend can basically be observed in most of the model countries. However, this increase does not guarantee an improvement in the number of medicine registrations. Although this is evident in some of the selected model countries, it cannot be projected to the entire African region. This may be linked to the diverse development of the individual countries due to the different political situations and the varying degrees of clinical research infrastructure.

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Metadaten
Author:Vanessa Strüver, Sheraz Ali, Firas Fneish, Gerhard FortwengelORCiDGND
URN:urn:nbn:de:bsz:960-opus4-21382
DOI:https://doi.org/10.25968/opus-2138
DOI original:https://doi.org/10.1016/j.curtheres.2021.100656
ISSN:0011-393X
Parent Title (English):Current Therapeutic Research
Document Type:Article
Language:English
Year of Completion:2022
Publishing Institution:Hochschule Hannover
Release Date:2022/01/03
Tag:clinical research; clinical trials; developing countries; medicine registrations
GND Keyword:Klinisches Experiment; Entwicklungsländer; Arzneimittel; Registrierung; Afrika
Volume:96
Article Number:100656
Page Number:7
Institutes:Fakultät III - Medien, Information und Design
DDC classes:610 Medizin, Gesundheit
Licence (German):License LogoCreative Commons - CC BY-NC-ND - Namensnennung - Nicht kommerziell - Keine Bearbeitungen 4.0 International