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A decline in the CD4 count is a common feature in HIV/AIDS, suggesting a compromise in immunity of patients. In response, highly active antiretroviral therapy (HAART) is prescribed to slow-down a diminution in the CD4 count and risk of AIDS-related malignancies. However, exercise may improve both the utility and population of innate immune cell components, and may be beneficial for patients with HIV infection. Comparing the effects of different exercises against HAART, on CD4 count, helps in understanding the role and evidence-based application of exercises to ameliorate immune deficiency.
Ever since the 1996 revision of the Declaration of Helsinki, the World Medical Association has attempted to address ethical and scientific concerns of its diverse stakeholders for Articles 33 (use of placebo) and 34 (posttrial provisions), most recently in 2013. Both are inextricably linked to standard of care, an essential element of any comparative, interventional clinical trial. But has this now 20-year-long ethical debate truly been put to rest? The choice of standard of care in clinical trials remains a complex issue, particularly for comparative trials conducted in emerging 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.
Economic and political/governmental infrastructural factors are major contributors to the economic development/growth of all sectors of a country, such as in the area of healthcare systems and clinical research, including the pharmaceutical industry. But what is the interaction between economic, and political/governmental infrastructural factors and the development of healthcare systems, especially, the performance of the pharmaceutical industry? Information from selected articles of a literature search of PubMed and by using Google Advanced Search led to the generation of five categories of infrastructural factors, and were filled with data from 41 African Countries using the World Health Organization data repository. Median changes over time were given and tested by Wilcoxon signed-rank test and Friedman test, respectively. Analysis of factors related to availability of healthcare facilities showed that physicians and pharmacies were significant increased, with insignificantly decreased number of hospital beds. Healthcare Financing by the Government showed notable differences. Private health spending decreased significantly unlike Gross National Income. Analysis of infrastructural factors showed that stable supply of electricity and the associated use of the Internet improved significantly. The low level of data on the expansion of paved road networks suggests less developed medical services in remote rural areas. Healthcare systems in African countries improved over the last two decades, but differences between the individual countries still prevail and some of the countries cannot yet offer an attractive sales market for the products of pharmaceutical companies.