Regulating clinical trials in a resource-limited setting during the Ebola public health emergency in Sierra Leone
Abstract Clinical trials during public health emergencies of novel medical products such as therapeutics and vaccines in resource-limited settings are daunting due to the limited capacity for regulatory assessment. Regulating clinical trials during the Ebola outbreak in Sierra Leone required expedit...
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| Format: | Article |
| Language: | English |
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BMC
2022-06-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-022-06416-4 |
| _version_ | 1811248108464504832 |
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| author | Onome T. Abiri Abdulai J. Bah Michael Lahai Durodami R. Lisk James P. Komeh Joy Johnson Wiltshire C. N. Johnson Sheku S. Mansaray Joseph Sam Kanu James B. W. Russell Fawzi Thomas Murtada M. Sesay Thomas A. Conteh Alphan Tejan-Kella Mohamed Sesay Manal Ghazzawi Brian Thompson Sorie Conteh Gibrilla Fadlu Deen |
| author_facet | Onome T. Abiri Abdulai J. Bah Michael Lahai Durodami R. Lisk James P. Komeh Joy Johnson Wiltshire C. N. Johnson Sheku S. Mansaray Joseph Sam Kanu James B. W. Russell Fawzi Thomas Murtada M. Sesay Thomas A. Conteh Alphan Tejan-Kella Mohamed Sesay Manal Ghazzawi Brian Thompson Sorie Conteh Gibrilla Fadlu Deen |
| author_sort | Onome T. Abiri |
| collection | DOAJ |
| description | Abstract Clinical trials during public health emergencies of novel medical products such as therapeutics and vaccines in resource-limited settings are daunting due to the limited capacity for regulatory assessment. Regulating clinical trials during the Ebola outbreak in Sierra Leone required expedited evaluation to identify medical products that could be promptly introduced to combat the epidemic in the absence of approved treatment or prevention. This article explored the decisions taken by the Pharmacy Board of Sierra Leone through its Expert Committee on Medicine Safety and Clinical Trials regarding clinical trials oversight during the Ebola epidemic and the lessons learned. This independent expert committee assessed and provided scientific opinions to the Pharmacy Board of Sierra Leone to inform approval of all clinical trials within 10–15 working days. We also requested for assisted review from the African Vaccine Regulatory Forum and support from the US Food and Drug Administration through a unilateral recognition and reliance memorandum of understanding. In addition, the Agency-ensured structures and systems were in place for reporting and reviewing adverse events and serious adverse events, management of biological samples, submission and review of progress reports, and good clinical practice inspections. Unfortunately, the Ebola epidemic revealed many weaknesses in the country’s clinical trials regulatory structure and processes. Government and partners should further offer more resources to build the clinical trial structures and systems so that the Agency will be better poised to handle future public health emergencies. |
| first_indexed | 2024-04-12T15:21:11Z |
| format | Article |
| id | doaj.art-ee5d2605c278459a9594dbd0606eddd6 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-12T15:21:11Z |
| publishDate | 2022-06-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-ee5d2605c278459a9594dbd0606eddd62022-12-22T03:27:26ZengBMCTrials1745-62152022-06-012311810.1186/s13063-022-06416-4Regulating clinical trials in a resource-limited setting during the Ebola public health emergency in Sierra LeoneOnome T. Abiri0Abdulai J. Bah1Michael Lahai2Durodami R. Lisk3James P. Komeh4Joy Johnson5Wiltshire C. N. Johnson6Sheku S. Mansaray7Joseph Sam Kanu8James B. W. Russell9Fawzi Thomas10Murtada M. Sesay11Thomas A. Conteh12Alphan Tejan-Kella13Mohamed Sesay14Manal Ghazzawi15Brian Thompson16Sorie Conteh17Gibrilla Fadlu Deen18Department of Pharmacology and Therapeutics, Faculty of Basic Medical Sciences, College of Medicine and Allied Health Sciences, University of Sierra LeoneDepartment of Pharmacology and Therapeutics, Faculty of Basic Medical Sciences, College of Medicine and Allied Health Sciences, University of Sierra LeonePharmacy Board of Sierra LeoneDepartment of Internal Medicine, Faculty of Clinical Sciences, College of Medicine and Allied Health Sciences, University of Sierra LeonePharmacy Board of Sierra LeoneDepartment of Pharmacology and Therapeutics, Faculty of Basic Medical Sciences, College of Medicine and Allied Health Sciences, University of Sierra LeonePharmacy Board of Sierra LeoneDepartment of Pharmacology and Therapeutics, Faculty of Basic Medical Sciences, College of Medicine and Allied Health Sciences, University of Sierra LeoneDepartment of Community Medicine, Faculty of Clinical Sciences, College of Medicine and Allied Health Sciences, University of Sierra LeoneDepartment of Internal Medicine, Faculty of Clinical Sciences, College of Medicine and Allied Health Sciences, University of Sierra LeonePharmacy Board of Sierra LeoneNational Medical Supplies AgencyPharmacy Board of Sierra LeonePharmacy Board of Sierra LeonePharmacy Board of Sierra LeoneCitiGlobe Pharmacies LtdDepartment of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, College of Medicine and Allied Health Sciences, University of Sierra LeoneDepartment of Internal Medicine, Faculty of Clinical Sciences, College of Medicine and Allied Health Sciences, University of Sierra LeoneDepartment of Internal Medicine, Faculty of Clinical Sciences, College of Medicine and Allied Health Sciences, University of Sierra LeoneAbstract Clinical trials during public health emergencies of novel medical products such as therapeutics and vaccines in resource-limited settings are daunting due to the limited capacity for regulatory assessment. Regulating clinical trials during the Ebola outbreak in Sierra Leone required expedited evaluation to identify medical products that could be promptly introduced to combat the epidemic in the absence of approved treatment or prevention. This article explored the decisions taken by the Pharmacy Board of Sierra Leone through its Expert Committee on Medicine Safety and Clinical Trials regarding clinical trials oversight during the Ebola epidemic and the lessons learned. This independent expert committee assessed and provided scientific opinions to the Pharmacy Board of Sierra Leone to inform approval of all clinical trials within 10–15 working days. We also requested for assisted review from the African Vaccine Regulatory Forum and support from the US Food and Drug Administration through a unilateral recognition and reliance memorandum of understanding. In addition, the Agency-ensured structures and systems were in place for reporting and reviewing adverse events and serious adverse events, management of biological samples, submission and review of progress reports, and good clinical practice inspections. Unfortunately, the Ebola epidemic revealed many weaknesses in the country’s clinical trials regulatory structure and processes. Government and partners should further offer more resources to build the clinical trial structures and systems so that the Agency will be better poised to handle future public health emergencies.https://doi.org/10.1186/s13063-022-06416-4Clinical trialEbolaVaccinesTherapeuticsDiagnosticsExpert committee |
| spellingShingle | Onome T. Abiri Abdulai J. Bah Michael Lahai Durodami R. Lisk James P. Komeh Joy Johnson Wiltshire C. N. Johnson Sheku S. Mansaray Joseph Sam Kanu James B. W. Russell Fawzi Thomas Murtada M. Sesay Thomas A. Conteh Alphan Tejan-Kella Mohamed Sesay Manal Ghazzawi Brian Thompson Sorie Conteh Gibrilla Fadlu Deen Regulating clinical trials in a resource-limited setting during the Ebola public health emergency in Sierra Leone Trials Clinical trial Ebola Vaccines Therapeutics Diagnostics Expert committee |
| title | Regulating clinical trials in a resource-limited setting during the Ebola public health emergency in Sierra Leone |
| title_full | Regulating clinical trials in a resource-limited setting during the Ebola public health emergency in Sierra Leone |
| title_fullStr | Regulating clinical trials in a resource-limited setting during the Ebola public health emergency in Sierra Leone |
| title_full_unstemmed | Regulating clinical trials in a resource-limited setting during the Ebola public health emergency in Sierra Leone |
| title_short | Regulating clinical trials in a resource-limited setting during the Ebola public health emergency in Sierra Leone |
| title_sort | regulating clinical trials in a resource limited setting during the ebola public health emergency in sierra leone |
| topic | Clinical trial Ebola Vaccines Therapeutics Diagnostics Expert committee |
| url | https://doi.org/10.1186/s13063-022-06416-4 |
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