Multiple-level stakeholder engagement in malaria clinical trials: addressing the challenges of conducting clinical research in resource-limited settings
Abstract Background Multinational clinical trials are logistically complex and require close coordination between various stakeholders. They must comply with global clinical standards and are accountable to multiple regulatory and ethical bodies. In resource-limited settings, it is challenging to un...
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| Format: | Article |
| Language: | English |
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BMC
2018-03-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-018-2563-1 |
| _version_ | 1818452517246205952 |
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| author | George Mtove Joshua Kimani William Kisinza Geofrey Makenga Peter Mangesho Stephan Duparc Miriam Nakalembe Kamija S. Phiri Russell Orrico Ricardo Rojo Pol Vandenbroucke |
| author_facet | George Mtove Joshua Kimani William Kisinza Geofrey Makenga Peter Mangesho Stephan Duparc Miriam Nakalembe Kamija S. Phiri Russell Orrico Ricardo Rojo Pol Vandenbroucke |
| author_sort | George Mtove |
| collection | DOAJ |
| description | Abstract Background Multinational clinical trials are logistically complex and require close coordination between various stakeholders. They must comply with global clinical standards and are accountable to multiple regulatory and ethical bodies. In resource-limited settings, it is challenging to understand how to apply global clinical standards to international, national, and local factors in clinical trials, making multiple-level stakeholder engagement an important element in the successful conduct of these clinical trials. Main body During the planning and implementation of a large multinational clinical trial for intermittent preventive treatment of malaria in pregnancy in resource-limited areas of sub-Saharan Africa, we encountered numerous challenges, which required implementation of a range of engagement measures to ensure compliance with global clinical and regulatory standards. These challenges included coordination with ongoing global malaria efforts, heterogeneity in national regulatory structures, sub-optimal healthcare infrastructure, local practices and beliefs, and perspectives that view healthcare providers with undue trust or suspicion. In addition to engagement with international bodies, such as the World Health Organization, the Malaria in Pregnancy Consortium, the Steve Biko Centre for Bioethics, and the London School of Hygiene and Tropical Medicine, in order to address the challenges just described, Pfizer Inc. and Medicines for Malaria Venture (the “Sponsoring Entities” for these studies) and investigators liaised with national- and district-level stakeholders such as health ministers and regional/local community health workers. Community engagement measures undertaken by investigators included local meetings with community leaders to explain the research aims and answer questions and concerns voiced by the community. The investigators also engaged with family members of prospective trial participants in order to be sensitive to local practices and beliefs. Conclusion Engagement with key stakeholders at international and national levels enabled the Sponsoring Entities to address challenges by aligning the study design with the requirements of health and regulatory agencies and to understand and address healthcare infrastructure needs prior to trial initiation. Local stakeholder engagement, including community members, study participants, and family enabled the investigators to address challenges by ensuring that study design and conduct were adapted to local considerations and ensuring accurate information about the study aims was shared with the public. Trial registration ClinicalTrials.gov, ID: NCT01103063. Registered on 7 April 2010. |
| first_indexed | 2024-12-14T21:24:21Z |
| format | Article |
| id | doaj.art-63b3f1adc2d747e1b1c6e7a4d68e83ff |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-14T21:24:21Z |
| publishDate | 2018-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-63b3f1adc2d747e1b1c6e7a4d68e83ff2022-12-21T22:46:51ZengBMCTrials1745-62152018-03-0119111110.1186/s13063-018-2563-1Multiple-level stakeholder engagement in malaria clinical trials: addressing the challenges of conducting clinical research in resource-limited settingsGeorge Mtove0Joshua Kimani1William Kisinza2Geofrey Makenga3Peter Mangesho4Stephan Duparc5Miriam Nakalembe6Kamija S. Phiri7Russell Orrico8Ricardo Rojo9Pol Vandenbroucke10National Institute for Medical Research, Amani Medical Research CentreCollege of Health Sciences, University of NairobiNational Institute for Medical Research, Amani Medical Research CentreNational Institute for Medical Research, Amani Medical Research CentreNational Institute for Medical Research, Amani Medical Research CentreMedicines for Malaria VentureSchool of Medicine, Makerere UniversityCollege of Medicine, University of MalawiPfizerPfizerPfizerAbstract Background Multinational clinical trials are logistically complex and require close coordination between various stakeholders. They must comply with global clinical standards and are accountable to multiple regulatory and ethical bodies. In resource-limited settings, it is challenging to understand how to apply global clinical standards to international, national, and local factors in clinical trials, making multiple-level stakeholder engagement an important element in the successful conduct of these clinical trials. Main body During the planning and implementation of a large multinational clinical trial for intermittent preventive treatment of malaria in pregnancy in resource-limited areas of sub-Saharan Africa, we encountered numerous challenges, which required implementation of a range of engagement measures to ensure compliance with global clinical and regulatory standards. These challenges included coordination with ongoing global malaria efforts, heterogeneity in national regulatory structures, sub-optimal healthcare infrastructure, local practices and beliefs, and perspectives that view healthcare providers with undue trust or suspicion. In addition to engagement with international bodies, such as the World Health Organization, the Malaria in Pregnancy Consortium, the Steve Biko Centre for Bioethics, and the London School of Hygiene and Tropical Medicine, in order to address the challenges just described, Pfizer Inc. and Medicines for Malaria Venture (the “Sponsoring Entities” for these studies) and investigators liaised with national- and district-level stakeholders such as health ministers and regional/local community health workers. Community engagement measures undertaken by investigators included local meetings with community leaders to explain the research aims and answer questions and concerns voiced by the community. The investigators also engaged with family members of prospective trial participants in order to be sensitive to local practices and beliefs. Conclusion Engagement with key stakeholders at international and national levels enabled the Sponsoring Entities to address challenges by aligning the study design with the requirements of health and regulatory agencies and to understand and address healthcare infrastructure needs prior to trial initiation. Local stakeholder engagement, including community members, study participants, and family enabled the investigators to address challenges by ensuring that study design and conduct were adapted to local considerations and ensuring accurate information about the study aims was shared with the public. Trial registration ClinicalTrials.gov, ID: NCT01103063. Registered on 7 April 2010.http://link.springer.com/article/10.1186/s13063-018-2563-1MalariaCommunity engagementLocal customsResource-limited settingsClinical trials |
| spellingShingle | George Mtove Joshua Kimani William Kisinza Geofrey Makenga Peter Mangesho Stephan Duparc Miriam Nakalembe Kamija S. Phiri Russell Orrico Ricardo Rojo Pol Vandenbroucke Multiple-level stakeholder engagement in malaria clinical trials: addressing the challenges of conducting clinical research in resource-limited settings Trials Malaria Community engagement Local customs Resource-limited settings Clinical trials |
| title | Multiple-level stakeholder engagement in malaria clinical trials: addressing the challenges of conducting clinical research in resource-limited settings |
| title_full | Multiple-level stakeholder engagement in malaria clinical trials: addressing the challenges of conducting clinical research in resource-limited settings |
| title_fullStr | Multiple-level stakeholder engagement in malaria clinical trials: addressing the challenges of conducting clinical research in resource-limited settings |
| title_full_unstemmed | Multiple-level stakeholder engagement in malaria clinical trials: addressing the challenges of conducting clinical research in resource-limited settings |
| title_short | Multiple-level stakeholder engagement in malaria clinical trials: addressing the challenges of conducting clinical research in resource-limited settings |
| title_sort | multiple level stakeholder engagement in malaria clinical trials addressing the challenges of conducting clinical research in resource limited settings |
| topic | Malaria Community engagement Local customs Resource-limited settings Clinical trials |
| url | http://link.springer.com/article/10.1186/s13063-018-2563-1 |
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