Abstract
Background: The difficulties of recruiting and retaining African women in biomedical research cannot be overemphasized. Despite the epidemiologic and gender distribution of the burden of diseases in Africa, women scarcely participate in biomedical research especially in clinical trials. This paper critically examines the challenges involved in recruiting and retaining African women in clinical trials using a pilot study in Nigeria. Methods: We carried out a pilot study through self-administered semi-structured questionnaire on knowledge, constraints and willingness by women to participate in clinical trials. Females attending outpatient obstetrics and gynecology clinics in Nigeria were the participants. The data collected was converted to numerical values for generation of statistic analysis. Results: Out of the 200 questionnaires distributed, 172 were returned anonymously representing 86% response rate, which were used in the data analysis. Eighty-two (47.7%) were willing to participate depending on the type of trials while 60 (35%) were concerned about monetary compensation. Most of the respondents (p < 0.05) were of the opinion that their husbands and families must be in support before they could participate. Discussion and Conclusion: This study has shown that knowledge and education play important role in motivating women to participate in clinical trials in Africa while family attachments and cultural barrier is an impediment to their participation. This calls for an awareness campaign to emphasize not only the necessity for women participation in clinical trial but also the establishment of adequate protective and educative measures for those willing to participate in a male dominated society like Nigeria.
Highlights
The difficulties of recruiting and retaining women in clinical trials as experienced in Africa cannot be underestimated
What the respondents considered as challenges to women participation and retention in clinical trials (Figure 1) were cultural barrier (56%), religious beliefs (32%) gender inequalities and discriminations (72%), ignorance and fear of adverse effect (64%) and Reasons P-value
Enrolment and retention of African women in clinical trials tend to be more difficult because of getting adequate informed consent from them, which is further complicated in women who lack formal education and may not understand the uncertainty that exists within the clinical trials procedures [6]
Summary
The difficulties of recruiting and retaining women in clinical trials as experienced in Africa cannot be underestimated. There are other reasons African women should be recruited in clinical trials, and they include; understanding the extent of the health problem, finding out which groups within the population are at highest and lowest risk, and characterizing the clinical response of the trial in women in comparison to that of men This in turn will assist health policy makers to evaluate the allocation of resources for more research, prevention, treatment, and support services in an environment like Nigeria that carries the burden of many diseases. Despite the epidemiologic and gender distribution of the burden of diseases in Africa, women scarcely participate in biomedical research especially in clinical trials.
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