Author: Omoleke, Semeeh Akinwale; Mohammed, Ibrahim; Saidu, Yauba
Title: Ebola Viral Disease in West Africa: A Threat to Global Health, Economy and Political Stability Document date: 2016_8_17
ID: tuk1l0b4_54
Snippet: Addressing technical and economic bottlenecks might not suffice to successfully move novel products through the late phases of clinical development. This is, partly, because establishing the true efficacy and safety of the product may require testing in countries where EVD is endemic. Most of these countries, however, lack the regulatory, ethics, infrastructural and logistical capacity to support the conduct of clinical trials. 112 This weakness .....
Document: Addressing technical and economic bottlenecks might not suffice to successfully move novel products through the late phases of clinical development. This is, partly, because establishing the true efficacy and safety of the product may require testing in countries where EVD is endemic. Most of these countries, however, lack the regulatory, ethics, infrastructural and logistical capacity to support the conduct of clinical trials. 112 This weakness may undermine the safety of subjects as well as credibility of clinical data. In addition, regulatory and ethical terrains in disease endemic countries are often complex, a weakness that can wreck trial planning and conduct. Therefore, there is a clear need for targeted African nations to act responsibly and take appropriate measures to support the development of these urgently needed interventions. Secondly, trials can only be successfully conducted, if communities volunteer to enroll and collaborate with investigators. As such, certain cultural beliefs and hostile behaviors from populations may delay timely availability of these interventions. Active cooperation from governments and other stakeholders is needed in this area to demystify some of these myths and engender trust in prospective trial communities.
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