Egharevba Efe, Atkinson Jacqueline
Glasgow University, Institute of Health & Wellbeing, 1 Lilybank Gardens, Glasgow, G12 8RZ, United Kingdom.
Contemp Clin Trials Commun. 2016 Apr 30;3:102-110. doi: 10.1016/j.conctc.2016.04.009. eCollection 2016 Aug 15.
Clinical trials still represent the gold standard in testing the safety and efficacy of new and existing treatments. However, developing regions including sub-Saharan Africa remain underrepresented in pharmaceutical industry sponsored trials for a number of reasons including fear of corruption and unethical behaviour. This fear exists both on the part of pharmaceutical companies, and investigators carrying out research in the region. The objective of this research was to understand the ethical considerations associated with the conduct of pharmaceutical industry sponsored clinical trials in sub-Saharan Africa. Corruption was identified as a significant issue by a number of stakeholders who participated in semi-structured interviews and completed questionnaires. Additionally, fear of being perceived as corrupt or unethical even when conducting ethically sound research was raised as a concern. Thus corruption, whether actual or perceived, is one of a number of issues which have precluded the placement of a greater number of pharmaceutical sponsored clinical trials in this region. More discussion around corruption with all relevant stakeholders is required in order for progress to be made and to enable greater involvement of sub-Saharan African countries in the conduct of industry sponsored clinical trials.
临床试验仍然是检验新的和现有治疗方法安全性和有效性的金标准。然而，包括撒哈拉以南非洲在内的发展中地区在制药行业赞助的试验中所占比例仍然较低，原因有很多，包括对腐败和不道德行为的担忧。制药公司以及在该地区开展研究的研究人员都存在这种担忧。本研究的目的是了解与在撒哈拉以南非洲开展制药行业赞助的临床试验相关的伦理考量。参与半结构化访谈并填写问卷的一些利益相关者将腐败确定为一个重大问题。此外，即使在进行符合伦理的研究时，也担心被视为腐败或不道德。因此，无论是实际的还是感知到的腐败，都是阻碍在该地区开展更多制药赞助临床试验的诸多问题之一。需要与所有相关利益者就腐败问题进行更多讨论，以便取得进展，并使撒哈拉以南非洲国家能够更多地参与制药行业赞助的临床试验。
