Regulating clinical trials in a resource-limited setting during the Ebola public health emergency in Sierra Leone

被引：1

作者：

Abiri, Onome T. ^{[1
,2
]}

Bah, Abdulai J. ^{[1
]}

Lahai, Michael ^{[2
,3
]}

Lisk, Durodami R. ^{[4
]}

Komeh, James P. ^{[2
,5
]}

Johnson, Joy ^{[1
,2
]}

Johnson, Wiltshire C. N. ^{[2
,5
]}

Mansaray, Sheku S. ^{[1
,2
]}

Kanu, Joseph Sam ^{[6
]}

Russell, James B. W. ^{[4
]}

Thomas, Fawzi ^{[2
]}

Sesay, Murtada M. ^{[7
]}

Conteh, Thomas A. ^{[2
]}

Tejan-Kella, Alphan ^{[2
]}

Sesay, Mohamed ^{[2
,3
]}

Ghazzawi, Manal ^{[8
]}

Thompson, Brian ^{[5
]}

Conteh, Sorie ^{[4
]}

Deen, Gibrilla Fadlu ^{[4
]}

机构：

[1] Univ Sierra Leone, Coll Med & Allied Hlth Sci, Fac Basic Med Sci, Dept Pharmacol & Therapeut, Freetown, Sierra Leone

[2] Pharm Board Sierra Leone, Freetown, Sierra Leone

[3] Univ Sierra Leone, Coll Med & Allied Hlth Sci, Fac Pharmaceut Sci, Dept Pharmaceut Chem, Freetown, Sierra Leone

[4] Univ Sierra Leone, Coll Med & Allied Hlth Sci, Fac Clin Sci, Dept Internal Med, Freetown, Sierra Leone

[5] Univ Sierra Leone, Coll Med & Allied Hlth Sci, Fac Pharmaceut Sci, Dept Clin Pharm, Freetown, Sierra Leone

[6] Univ Sierra Leone, Coll Med & Allied Hlth Sci, Fac Clin Sci, Dept Community Med, Freetown, Sierra Leone

[7] Natl Med Supplies Agcy, Freetown, Sierra Leone

[8] CitiGlobe Pharm Ltd, Freetown, Sierra Leone

来源：

TRIALS | 2022年 / 23卷 / 01期

关键词：

Clinical trial; Ebola; Vaccines; Therapeutics; Diagnostics; Expert committee; Medicine regulatory authority; Sierra Leone;

D O I：

10.1186/s13063-022-06416-4

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

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.

引用

页数：8

共 22 条

[1]

Abayomi A., 2016, GLOBAL SECURITY HLTH, V1, P51, DOI [10.1080/23779497.2016.1228431, DOI 10.1080/23779497.2016.1228431]

[2] Pharmacovigilance systems in resource-limited settings: an evaluative case study of Sierra Leone [J].