Jornal de Pesquisa Clínica e Bioética

Abstrato

The Challenges in Enrolment and Retention of African Women in Clinical Trials: A Pilot Study in Nigeria

Chukwuneke FN, Ekwueme OC, Ezeonu PO, Onyire BN and Ifebunandu N

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.