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International Clinical Trial Day and clinical trials in Ethiopia and Africa.

Fekadu A, Teferra S, Hailu A, Gebre-Mariam T, Addissie A, Deressa W, Yimer G, Reja A - Trials (2014)

Bottom Line: Low income countries like Ethiopia are underrepresented in clinical research.However, administrative capacity, research infrastructure as well as financial support remain weak.There is a need for enhanced university-industry linkage and translation of research findings into locally relevant evidence.

View Article: PubMed Central - PubMed

Affiliation: Department of Psychiatry, School of Medicine, College of Health Sciences, Addis Ababa University, Zambia Street, PO Box 9086, Addis Ababa, Ethiopia. abe.wassie@kcl.ac.uk.

ABSTRACT
Low income countries like Ethiopia are underrepresented in clinical research. As a major public commitment to clinical research, Ethiopia celebrated the International Clinical Trial Day (ICTD) for the first time on 20 May 2014 under the auspices of Addis Ababa University. The motto for the day was 'Clinical Trials for Excellence in Patient Care'. The celebration offered an opportunity to inform academic staff, researchers, students and the leadership about clinical trials being conducted and to discuss the future of clinical trials in the country. Although clear challenges to the conduct of trials abound, clinical trials registered from Ethiopia in trial registration databases is increasing. Cross-country collaborations, international funding support, motivation of academic staff to conduct clinical trials and the commitment and engagement of the leadership in research are all improving. The overall impact of clinical trials is also encouraging. For example, some of the trials conducted in Ethiopia have informed treatment guidelines. However, administrative capacity, research infrastructure as well as financial support remain weak. There is a need for enhanced university-industry linkage and translation of research findings into locally relevant evidence. Ethiopia, as well as the whole of Africa, has an unparalleled opportunity to lead the way in clinical trials, given its prospect of development and the need to have locally relevant evidence for its growing population. In this commentary we reflect on the celebration of ICTD, the status and opportunities for conducting clinical trials and the way forward for facilitating clinical trials in Ethiopia and Africa.

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Strength Weakness Opportunity and Threat (SWOT) analysis of the context for clinical trials in Ethiopia.
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Fig2: Strength Weakness Opportunity and Threat (SWOT) analysis of the context for clinical trials in Ethiopia.

Mentions: The global disparity in clinical research capacity and service provision may be indicated simply through the share of clinical trials a country or a region has registered in clinical trial registry databases. We have called this the ‘clinical trials index’ (CTI). For example, the share of studies registered from Africa (in Clinicaltrials.gov) is only 0.02%, although the region represents about 15% of the population of the world. Within Africa, most of the clinical trials are conducted in South Africa (47.3%), which makes one of the largest financial investments on health and has a relatively well-developed health system in Africa [11]. Only a limited number of clinical trials are registered from Ethiopia in trial registration sites, representing only 1.5% of all the studies from Africa. These CTI figures are crude reflections of the disparity in clinical research and service capacities within Africa and the world at large. Despite the limited number, some of the studies from Ethiopia were very important. For example, the World Health Organization (WHO) recommended sodium stibogluconate and paromomycin as first line treatments for visceral leishmaniasis in East Africa, based on clinical trials conducted in Ethiopia as part of an East African consortium (Leishmaniasis East Africa Platform (LEAP)) [12]. Equally important was the differential response pattern of leishmaniasis within the East African countries [12]. For example, in assessing the response to different formulations of stibogluconate, it was found that the response rate was lower among the Ethiopian sample [13]. Patients with HIV co-infection also had very poor treatment response [7]. Differential treatment response was also demonstrated between different regions within Ethiopia, partly accounted for by nutritional status [14]. This clearly underscores the need to have locally relevant evidence for different populations and the need for expertise in clinical trials in each country. Understandably, most of the clinical trials conducted in Ethiopia were for infectious diseases (Figures 2 and 3). However, clinical trials for non-communicable diseases (NCD) are also very important. First, NCDs are becoming increasingly relevant, and given their chronicity, are likely to take a big share of the health investment of any country. Underscoring the relevance of NCDs was a major focus on the United Nations Assembly in September 2011 [15]. NCDs have been considered a leading cause of death in all world regions with rapidly increasing burden [16]. In the context of the ‘double transition’, Africa is likely to be disproportionately affected by NCDs. Secondly, treatment of NCDs is likely to require more local adaptations than treatment of infectious conditions. Thirdly, the ethical requirements for the conduct of clinical trials for NCDs, particularly those that rely on non-medication interventions or those looking at secondary indications of existing treatments, are likely to be different.Figure 2


International Clinical Trial Day and clinical trials in Ethiopia and Africa.

Fekadu A, Teferra S, Hailu A, Gebre-Mariam T, Addissie A, Deressa W, Yimer G, Reja A - Trials (2014)

Strength Weakness Opportunity and Threat (SWOT) analysis of the context for clinical trials in Ethiopia.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4300613&req=5

Fig2: Strength Weakness Opportunity and Threat (SWOT) analysis of the context for clinical trials in Ethiopia.
Mentions: The global disparity in clinical research capacity and service provision may be indicated simply through the share of clinical trials a country or a region has registered in clinical trial registry databases. We have called this the ‘clinical trials index’ (CTI). For example, the share of studies registered from Africa (in Clinicaltrials.gov) is only 0.02%, although the region represents about 15% of the population of the world. Within Africa, most of the clinical trials are conducted in South Africa (47.3%), which makes one of the largest financial investments on health and has a relatively well-developed health system in Africa [11]. Only a limited number of clinical trials are registered from Ethiopia in trial registration sites, representing only 1.5% of all the studies from Africa. These CTI figures are crude reflections of the disparity in clinical research and service capacities within Africa and the world at large. Despite the limited number, some of the studies from Ethiopia were very important. For example, the World Health Organization (WHO) recommended sodium stibogluconate and paromomycin as first line treatments for visceral leishmaniasis in East Africa, based on clinical trials conducted in Ethiopia as part of an East African consortium (Leishmaniasis East Africa Platform (LEAP)) [12]. Equally important was the differential response pattern of leishmaniasis within the East African countries [12]. For example, in assessing the response to different formulations of stibogluconate, it was found that the response rate was lower among the Ethiopian sample [13]. Patients with HIV co-infection also had very poor treatment response [7]. Differential treatment response was also demonstrated between different regions within Ethiopia, partly accounted for by nutritional status [14]. This clearly underscores the need to have locally relevant evidence for different populations and the need for expertise in clinical trials in each country. Understandably, most of the clinical trials conducted in Ethiopia were for infectious diseases (Figures 2 and 3). However, clinical trials for non-communicable diseases (NCD) are also very important. First, NCDs are becoming increasingly relevant, and given their chronicity, are likely to take a big share of the health investment of any country. Underscoring the relevance of NCDs was a major focus on the United Nations Assembly in September 2011 [15]. NCDs have been considered a leading cause of death in all world regions with rapidly increasing burden [16]. In the context of the ‘double transition’, Africa is likely to be disproportionately affected by NCDs. Secondly, treatment of NCDs is likely to require more local adaptations than treatment of infectious conditions. Thirdly, the ethical requirements for the conduct of clinical trials for NCDs, particularly those that rely on non-medication interventions or those looking at secondary indications of existing treatments, are likely to be different.Figure 2

Bottom Line: Low income countries like Ethiopia are underrepresented in clinical research.However, administrative capacity, research infrastructure as well as financial support remain weak.There is a need for enhanced university-industry linkage and translation of research findings into locally relevant evidence.

View Article: PubMed Central - PubMed

Affiliation: Department of Psychiatry, School of Medicine, College of Health Sciences, Addis Ababa University, Zambia Street, PO Box 9086, Addis Ababa, Ethiopia. abe.wassie@kcl.ac.uk.

ABSTRACT
Low income countries like Ethiopia are underrepresented in clinical research. As a major public commitment to clinical research, Ethiopia celebrated the International Clinical Trial Day (ICTD) for the first time on 20 May 2014 under the auspices of Addis Ababa University. The motto for the day was 'Clinical Trials for Excellence in Patient Care'. The celebration offered an opportunity to inform academic staff, researchers, students and the leadership about clinical trials being conducted and to discuss the future of clinical trials in the country. Although clear challenges to the conduct of trials abound, clinical trials registered from Ethiopia in trial registration databases is increasing. Cross-country collaborations, international funding support, motivation of academic staff to conduct clinical trials and the commitment and engagement of the leadership in research are all improving. The overall impact of clinical trials is also encouraging. For example, some of the trials conducted in Ethiopia have informed treatment guidelines. However, administrative capacity, research infrastructure as well as financial support remain weak. There is a need for enhanced university-industry linkage and translation of research findings into locally relevant evidence. Ethiopia, as well as the whole of Africa, has an unparalleled opportunity to lead the way in clinical trials, given its prospect of development and the need to have locally relevant evidence for its growing population. In this commentary we reflect on the celebration of ICTD, the status and opportunities for conducting clinical trials and the way forward for facilitating clinical trials in Ethiopia and Africa.

Show MeSH
Related in: MedlinePlus