The impact of clinical research activities on communities in rural Africa: the development of the Clinical Research Unit of Nanoro (CRUN) in Burkina Faso
- Halidou Tinto1, 2, 3,
- Innocent Valea1, 3Email author,
- Hermann Sorgho2, 3,
- Marc Christian Tahita2, 3,
- Maminata Traore2, 3,
- Biébo Bihoun3,
- Issa Guiraud3,
- Hervé Kpoda1, 3,
- Jérémi Rouamba1,
- Sayouba Ouédraogo3,
- Palpouguini Lompo3,
- Sandrine Yara3,
- William Kabore3,
- Jean-Bosco Ouédraogo1, 2,
- Robert Tinga Guiguemdé1, 4,
- Fred N Binka5 and
- Bernhards Ogutu5
© Tinto et al.; licensee BioMed Central Ltd. 2014
Received: 5 December 2013
Accepted: 10 March 2014
Published: 22 March 2014
The opportunities for developing new drugs and vaccines for malaria control look brighter now than ten years ago. However, there are few places in sub-Saharan Africa with the necessary infrastructure and expertise to support such research in compliance to international standards of clinical research (ICH-GCP). The Clinical Research Unit of Nanoro (CRUN) was founded in 2008 to provide a much-needed GCP-compliant clinical trial platform for an imminent large-scale Phase 3 malaria vaccine trial. A dynamic approach was used that entailed developing the required infrastructure and human resources, while engaging local communities in the process as key stakeholders. This provided a better understanding and ownership of the research activities by the local population.
Within five years (2008–2013), the CRUN set up a fully and well-equipped GCP-compliant clinical trial research facility, which enabled to attract 25 grants. The research team grew from ten health workers prior to 2008 to 254 in 2013. A Health and Demographic Surveillance System (HDSS), which covers a total population of about 60,000 people in 24 villages was set up in the district. The local community contributed to the development of the facility through the leadership of the king and the mayor of Nanoro. As a result of their active advocacy, the government extended the national electrical grid to the new research center, and later to the entire village. This produced a positive impact on the community’s quality of life. The quality of health care improved substantially, due to the creation of more elaborate clinical laboratory services and the acquisition of state-of-the-art equipment.
Involving the community in the key steps of establishing the centre provided the foundation for what was to become the CRUN success story. This experience demonstrates that when clinical trials research sites are carefully developed and implemented, they can have a positive and powerful impact on local communities in resource-poor settings, well beyond the task of generating expected study data.
The epidemiology of malaria in sub-Saharan Africa is changing, with a decline in malaria-attributed deaths . This is largely due to a significant increase in the financial commitment to the battle against malaria, followed by the implementation and scaling-up of effective interventions, such as artemisinin-based combination therapy (ACT), long-lasting insecticidal bed nets (LLIN), intermittent preventive treatment in pregnant women with SP (IPTp-SP) and, more recently, the seasonal malaria chemoprophylaxis (SMC). Considering the funds that are currently available to the malaria research community, the opportunities for the development of new drugs and vaccines for malaria control look brighter now than 10 years ago . However, it is unclear if and how the downward trend in malaria cases and deaths can be maintained and what new tools are needed for the eventual elimination of malaria. Despite reports of dramatic declines in the burden of malaria in a number of countries , it remains stubbornly high in many areas, such as Burkina Faso. Elsewhere, a decline in malaria was followed by its reintroduction due to close proximity to areas of appreciable transmission . In this context, it is extremely important to establish the safety, efficacy, and effectiveness of new interventions . Yet, there are few places in sub-Saharan Africa with the necessary infrastructure and expertise to conduct such research in accordance to international standards (ICH-GCP). Moreover, very few African research centres have been able to maintain the required infrastructure and expertise over time, despite having conducted GCP-compliant clinical trials in the past. One reason is that the subsistence of the centres is often linked to one or only a few specific projects, which are time-bound and resource-limited. Once a specific project ends, experienced staff cannot be maintained. A number of centres in the region operate as field sites for Northern institutions. Therefore, they lack the leverage of autonomy to drive a local agenda and development plan. Such circumstances have major impacts on the ability of truly African centres, with competent local investigators, to compete for international funds. Nevertheless, it should be recognized that in the most recent years this is changing. In fact, some of African key senior scientists through some initiatives, such as the European and Developing Countries Trial Partnership (EDCTP) are becoming part of the main drivers of the research agenda.
There is a clear need to establish sustainable clinical research centres operating in accordance to international standards for the timely evaluation of new products and interventions . This recognition led to the creation of the Clinical Research Unit of Nanoro (CRUN), which today provides a ready platform for testing new interventions in the environment where eventually they may be deployed. The CRUN is jointly run by two Burkinabe medical research institutions—namely the Centre Muraz (CM) and the Institut de Recherche en Sciences de la Santé (IRSS)—in collaboration with the Saint Camille Medical Center of Nanoro (CMA), which is a referral hospital for the District of Nanoro and is run by an Italian religious order in partnership with the government. The team was able to set-up a high-quality platform fully compliant with international standards for training and research and a Health and Demographic Surveillance System (HDSS) of about 60,000 people. To establish this capacity, CRUN leaders used a dynamic approach that engaged the local community throughout the process.
The birth of CRUN
The main objective of establishing the CRUN was to develop and maintain an appropriate expertise and infrastructure ensuring high quality clinical research and training. The vision of the CRUN is to become a prominent research and training centre in sub-Saharan Africa, to participate in the formulation of African public health strategies and programs, and to provide competent expertise in the health field. The CRUN’s mission is to provide evidence-based information for the health care of populations living in tropical countries, with a specific focus on malaria. This will be achieved by providing an excellent platform for training and research in tropical diseases in full compliance with international standards. This platform could be offered to address some specific research questions relevant to the MoH local agenda and development plan. In fact, having the Centre Muraz as partner in this initiative gives the opportunity to the CRUN to have a link with the MoH stakeholders such as the National Programs, including the malaria control programme and the national drug regulatory authorities, helping in the translation of research findings into practice.
Organization and management
The two institutions (CM and IRSS) collaborating to run the CRUN are both located in Bobo-Dioulasso in the south-west of Burkina Faso. They are closely linked in and have been working together for the last 20 years. The CM is under the auspices of the Ministry of Health, while the IRSS is housed in the Ministry of Research and Innovation. The CM/IRSS is the largest medical research group in Burkina Faso and among the largest in the West African Francophone countries. The team’s scientific interest is mainly malaria research, but studies on other parasitic diseases (helminthiasis, filariasis, schistosomiasis) have been conducted. The team provides also support for training health practitioners (MD, PharmD, Msc, PhD) in collaboration with national universities (Ouagadougou and Bobo-Dioulasso). The linkage to academic institutions is a great asset as it provides a pathway for career development, sustainable career progression, and reliable availability of younger scientists.
At the inception of the research activities in Nanoro, the CRUN management structure was project oriented, i.e., each project had its own leader and team, with little coordination among the different projects. However, this changed in 2010 with the introduction of a more transversal organization across the different projects. The CRUN has been organized in five sections: laboratory, clinical activities, IT & data management, Health & Demographic Surveillance System (HDSS), and pharmacy, each with a designated manager.
Infrastructure refurbishment and equipment upgrades
Before the grants provided by MCTA (2005–2008), the CRUN was hosted by the CMA of Nanoro and research activities were conducted within the hospital complex. A small clinical ward was dedicated to clinical trial activities, while the laboratory facility was shared with the hospital. In 2009, the site constructed a new clinical trial facility, which was funded by MCTA, and where most of its research activities was transferred to. A fully functioning clinical laboratory (parasitology, biochemistry, haematology, microbiology and blood/cells culture) has been set up with the new equipment, including back-up equipment to ensure reliable services. The government of Burkina Faso, in recognizing the national interest in clinical research for a vaccine and other malaria interventions, extended the national electrical grid to the trial site and the village of Nanoro. Providing reliable electricity has proven to be a great achievement for this challenging initiative. Throughout the development of CRUN, the leadership of MCTA remained engaged, providing invaluable technical and mentorship support. A grant was provided in 2008 by the Belgium Cooperation through the Institute of Tropical Medicine Framework Agreement 3 (ITM FA3) was also of significant help. Although modest compared to MCTA funds, it provided support for three PhD grants and thus, contributed to creating a core group of young scientists able to attract additional new grants.
Research activities and grants obtained
List of research projects grants awarded since the CRUN establishment in 2008
Title of the study/activity funded
Pharmacovigilance for Artemisinin-based combination treatments in Africa
World Health Organization/(WHO/TDR)
Multi-drug resistance in malaria under combination therapy Assessment of specific markers and development of innovative, rapid and simple diagnostics (MALACTRES)
European Union (FP7)
Pharmacokinetics of Mefloquine-Artesunate in Pregnant Women with Plasmodium falciparum infection
Malaria in Pregnancy (MiP) Consortium
A Phase II multicenter, efficacy and safety study of parenteral SAR97276A
Safe and efficacious artemisinin-based combination treatments for African pregnant women with malaria
European and Developing Countries Partnership (EDCTP)
Efficacy of GSK Biologicals. candidate malaria vaccine (257049)against malaria disease caused by P. falciparum infection in infants and children in Africa
Malaria Vaccine Initiative (MVI)
Parallel group, double-blind, randomized study assessing the efficacy, safety and pharmacokinetic profile of ferroquine associated with artesunate
Assessment of the Safety of Anti-malarial Drug Use During Early Pregnancy
Malaria in Pregnancy (MiP) Consortium
Malaria risk prior to and during early pregnancy in nulliparous women receiving long-term weekly iron and folic acid supplementation
National Institute of Health (NIH)
Epidemiology study of malaria transmission intensity in sub-Saharan Africa
Malaria Vaccine Initiative (MVI)
Study of immune correlates of protection against malaria after vaccination with RTS, S/AS01E
Malaria Vaccine Initiative (MVI)
Multi-methods study on Clinical Trial participation and the informed consent process in vulnerable populations
Site characterization as a prelude to a study of malaria elimination using a combination of malaria control strategies in the Sahel region of Burkina Faso
Malaria Capacity Development Consortium (MCDC)
Phase III randomized, open, controlled study to evaluate the immune response to the hepatitis B antigen of the RTS,S/AS01E candidate vaccine
GlaxoSmithKline (GSK) Biologicals
Improved quality of diagnostic services for malaria in pregnancy
World Health Organization/(WHO/TDR)
Severe malaria and invasive bacterial disease among children: proportions, incidence rates and diagnostic value of Malaria Rapid Diagnostic Tests (ongoing)
Institute of Tropical Medicine (Belgium Cooperation)
Community-based scheduled screening and treatment of malaria in pregnancy for improved maternal and infant health: a cluster-randomized trial in The Gambia, Burkina Faso and Benin
European Union (EU FP7)
Genomic and environmental risk factors for cardio-metabolic disease in Africans.
National Institute of Health (NIH)
Study of the Incidence, Reservoir and Routes of Transmission of Invasive Salmonellosis in Burkina Faso (IRTIS -BF)
Institute of tropical medicine (Belgium Cooperation)
An open-label, single-arm study to evaluate the efficacy, safety and PK of Artemether-Lumefantrine dispersible tablet in the treatment of acute uncomplicated Plasmodium falciparum malaria in infants <5 kg body weight
A phase II, open-label, multicentre, pharmacokinetic, pharmacodynamics and safety study of a new paediatric eurartesim dispersible formulation and crushed film coated eurartesim tablet, in infant patients with Plasmodium falciparum malaria
Observational study to evaluate the clinical safety after introduction of the fixed-dose Artemisinin-based Combination Therapy Eurartesim® (dihydroartemisinin/piperaquine [DHA/PQP]) in public health districts in Burkina Faso, Mozambique, Ghana and Tanzania
List of other activities’ grants awarded since the CRUN establishment in 2008
Title of the study/activity funded
Grant to support the establishment of Malaria Clinical Research Unit in Burkina Faso
Support for the establishment of a Pharmacovigilance system for ACT safety monitoring in Burkina Faso
Good Clinical Practice: a theoretical and practical training in Burkina Faso
CRUN’s enhanced infrastructure has enabled the centre to network with other research and academic centres, for example, by hosting two international GCP courses in 2010 and 2012, supported by Belgium Cooperation and the Institute of Tropical Medicine (ITM) Clinical Trial Strategic Network activities. The two courses brought together 34 participants from four different geographical areas (East and West Africa, Southeast Asia and Latin America) . The course had a very innovative approach, consisting of theory, case studies and a practical segment in the field. Having participants from different geographical areas provided a dynamic experience as the participants examined clinical research challenges from diverse regions in a complementary manner.
Impact of the CRUN establishment on the community
In the literature, few studies have been conducted to address the impact of clinical trials and clinical trial platforms on trial participants, their families and communities [14–16]. Lessons learnt from these reports indicate that clinical trials, especially when conducted in resource-poor settings, may negatively impact the quality of health care, e.g., by diverting resources from routine clinical activities, brain-drain among the best qualified health staff, discrimination of enrolled versus non-enrolled persons, or differentiating trial investigators from other health staff. The clinical trial may also have a negative impact on the relationship between a health facility and the community; for instance, in cases of poor or inappropriate communication about the nature and the objectives of the research or a lack of knowledge about local culture and customs by researchers. Conversely, clinical trials can contribute to the quality of routine healthcare and thus the wellbeing of a community, either directly (additional training of health staff and structural upgrades of health facilities) or indirectly (improved access to healthcare that improves the quality of routine healthcare .
No formal study has been conducted to assess the impact of the CRUN on the Nanoro community; however, the interactive approach led by local researchers obviated the negative perceptions and lack of understanding about the intentions and conduct of CRUN’s research activities. Researchers involved the community (district health management, elders, chief, and opinion leaders) in the founding steps of establishing the CRUN. To make the community a real partner in the centre’s activities, a tacit agreement was made that priority would be given to local people, in a competitive manner, for all non-professional jobs (construction workers, drivers, cleaners, field workers, data clerks, and others). Of the 254 people employed at the CRUN, about one-third come from Nanoro. This has strengthened the sense of ownership of the centre’s activities by the community. Through the modest creation of new jobs, CRUN makes a substantial contribution to reducing poverty in the community. In addition, staff members residing in Nanoro contribute to the micro-economy there.
Another crucial benefit for Nanoro and CRUN stemming from their productive engagement was electrification for the area. This was made possible by the mayor of Nanoro leading the negotiations for extending the national electrical grid to the CRUN, and with it, to the village of Nanoro. Electrification spurred a lot of economic activity and social amenities that enhance the wellbeing of the community, such as: (1) improved water supply through use electricity instead of generator; (2) ability to use electrical devices, such as fans during the hot season (when temperatures can reach 45-47°C), lighting so students can study at night, the use of refrigeration to safely store food and the extension of business hours past sunset.
Health care services have been improved through CRUN’s new microbiology laboratory. Before this laboratory was established, local patients had to travel about 100 km to the capital city, Ouagadougou, for the service. In addition, putting the local hospital on the electrical grid improved the working conditions of the health professionals, notably the ability to conduct surgery 24 hours a day and optimal storage of EPI vaccines at district health facilities. Last, but not least, in terms of benefits, is the installation of digital X-ray equipment (the first in Burkina Faso), which is now used for all patients attending the hospital regardless of their participation in the clinical trials.
The innovative interactive approach to developing the CRUN based on active engagement with the community, have been central to establishing the centre and providing the foundation for the CRUN success story. Aside from the positive impact of the infrastructure upgrade on the standard of health care services, the electrification of the trial site positively impacted the quality of life in the community. This demonstrates that strong positive advocacy can lead African governments to take on more responsibility in supporting research activities. However the main challenge for CRUN in the future will be to secure and strengthen the capacity established. For that, the CRUN future strategic development plans should take into account the “epidemiological transition” of malaria with the decline of the number of clinical cases in endemic countries and the concomitant need for research in other endemic diseases. Therefore, beside malaria, currently the main research subject, the activity of the unit should be gradually expanded to other diseases, such as invasive bacterial infections, tuberculosis, HIV, reproductive health, schistosomiasis and other neglected diseases. In addition, the HDSS platform which is so far mainly used for research activities should be more and more used to guide the district health management team. Indeed, the HDSS by providing reliable health information such as burden of disease profiles will contribute to a better evaluation of health interventions by the Nanoro Health District. The success story of the CRUN establishment demonstrates that the impact of clinical trials on the community can be highly positive in resource-poor settings if the concerned community is involved in the process.
We thank the Malaria Clinical Trial Alliance (MCTA) for supporting the establishment of the CRUN through its robust financial support for infrastructure construction and equipment. Since 2008, the CRUN has been the beneficiary of a grant from The Institute of Tropical Medicine, Antwerp through the Belgian Cooperation Framework Agreement 3 covering the period 2008–2013 (FA3: 2008–2013). Thanks also go to Prof. Umberto d’Alessandro for the support and mentorship given to the CRUN through the FA3 and David Poland for providing his inputs to improve the manuscript.
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