Clinical trials are prospective studies in volunteers to test the safety and efficacy of a drug or intervention in a well-defined, controlled experiment. Pharmaceutical companies spend billions of dollars each year on clinical trials. Yet, despite the rising levels of chronic diseases and evidence suggesting that black patients may respond to treatments differently than their white counterparts, Sub-Saharan Africa is still represented in very few industry-sponsored trials. In addition to any immediate potential therapeutic benefit and the ability to grant patients greater access to drugs that they might not normally be able to obtain, clinical trials may also bring collateral benefits, such as investments in infrastructure and resources. To this end, clinical trials may be useful in helping to address the rising levels of chronic disease in the Sub-Saharan region of Africa. Additionally, it may not always be appropriate to extrapolate data from trials conducted in patients in the West and apply them to patients in other regions of the world, as the literature demonstrates that for certain medicines, treatment effects may differ due to genetic variations between ethnic groups. Aim: The aim of the study was to better understand stakeholder perceptions of the issues associated with the conduct of pharmaceutical industry-sponsored clinical trials in chronic diseases in Sub-Saharan Africa. A further goal was understanding what benefit, if any, conducting such trials could confer to the population and region. Methods: A multi-methods approach was adopted. The first part of the study focused on the use of semi-structured qualitative interviews with various stakeholders to identify the themes most relevant to the research objectives. The contents of the interview transcripts were thematically analysed, and a quantitative online questionnaire was created on the basis of the themes that emerged from the interviews. This questionnaire was then administered to a larger number of similar stakeholders to corroborate the findings from the first part of the study. Results: The interviews identified five main overarching themes. Those themes were as follows: (1) ethical, (2) commercial, (3) medical/scientific, (4) educational, and (5) practical. All five themes are closely related and oftentimes impact one another. The ethical issues largely related to the provision and availability of medicines post-trial and informed consent, as well as to the potential for corruption and fraud by both investigators and pharmaceutical companies operating outside the scope of tightly regulated Western competent authorities and ethics committees. The commercial considerations that were raised primarily centred on the fact that pharmaceutical companies are businesses, many of which have obligations to shareholders, and on the fact that drug development is tremendously expensive. The majority of the profit generated by pharmaceutical companies comes from their sales in the West, which is why their focus remains on that part of the world. The medical and scientific issues were primarily related to the evolution of Sub-Saharan Africa’s disease landscape and pharmaceutical companies’ responsibility to their global patients to ensure a robust understanding of how their drugs affect patients of varying ethnic backgrounds in different parts of the world. The educational issues were mainly linked to public awareness regarding what clinical trials are, as well as to the education of investigators, research staff, and ethics committee members. The final theme to emerge was practical issues raised in relation to a lack of infrastructure and oversight. The results of the questionnaire mostly echoed the findings of the interviews. Through their questionnaire responses, participants indicated that they felt that the pharmaceutical industry does have an ethical and scientific responsibility to do more to ensure that its drugs are tested in developing parts of the world, such as Sub-Saharan Africa. However, respondents indicated that pharmaceutical companies should not conduct trials in regions where they have no intention of selling their products and that the three largest barriers precluding the conduct of clinical trials in that part of the world are a lack of adequate infrastructure, a lack of commercial attractiveness, and concerns around unethical behaviour. Discussion: Although there are inherent risks and disadvantages associated with participating in clinical trials, the benefits are well known and understood for participants in the West. Therefore, most respondents across the stakeholder groups could see the potential benefits of research for Sub-Saharan Africa. However, many within the pharmaceutical stakeholder group exhibited unfamiliarity with the evolving disease landscape and level of infrastructure within Sub-Saharan Africa. The ethical issues and associated practicalities of conducting trials in that part of the world were likewise not well understood. The results of the study suggest that respondents across all stakeholder groups feel that the pharmaceutical industry needs to do more to make drugs available to patients in developing countries, both commercially and through research. As a justification, they pointed to the industry’s ethical and scientific responsibilities to do so. The commercial benefits that the industry could gain from conducting an increased number of clinical trials in Sub-Saharan Africa did not appear to be well understood by the research participants. The results also illustrated that the respondents did not think that chronic diseases should be prioritised over infectious diseases, or vice versa. By carrying out this research, important questions were raised regarding the capabilities of countries within Sub-Saharan Africa, and topics associated with the increasing prevalence of chronic diseases in that region were explored. All stakeholder groups agreed that pharmaceutical companies can play a role in addressing levels of rising chronic disease through the conduct of clinical trials. The findings of this research led to several recommendations, including allowing countries in the region to participate in bridging studies as a starting point, establishing national databases, and revisiting the restrictive wording in certain current ethical regulations.
| Identifer | oai:union.ndltd.org:bl.uk/oai:ethos.bl.uk:726675 |
| Date | January 2017 |
| Creators | Egharevba, Terry |
| Publisher | University of Glasgow |
| Source Sets | Ethos UK |
| Detected Language | English |
| Type | Electronic Thesis or Dissertation |
| Source | http://theses.gla.ac.uk/8451/ |
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