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Regulating clinical trials in a resource-limited setting during the Ebola public health emergency in Sierra Leone
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. I...
Source: Trials - June 6, 2022 Category: Research Source Type: clinical trials

Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries
DiscussionThe PREVAC trial is evaluating —placebo-controlled—two promising Ebola candidate vaccines in advanced stages of development. The results will address unanswered questions related to short- and long-term safety and immunogenicity for three vaccine strategies in adults and children.Trial registrationClinicalTrials.govNCT02876328. Registered on 23 August 2016. (Source: Trials)
Source: Trials - January 23, 2021 Category: Research Source Type: clinical trials

Effect of an Alternative RUTF on Intestinal Permeability in Children With Severe Acute Malnutrition
Condition: Malnutrition, Child Interventions: Dietary Supplement: S-RUTF; Dietary Supplement: oat RUTF Sponsors: Washington University School of Medicine; Project Peanut Butter, Sierra Leone; Ministry of Health and Sanitation, Government of Sierra Leone Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - April 6, 2020 Category: Research Source Type: clinical trials