Practical Guidelines for Standardised Resolution of Important Protocol Deviations in Clinical Trials Conducted in Sub-Saharan Africa.

A clinical trial is any research on human subjects that involves an investigational medicinal product or device. Investigational medicinal products include unlicensed drugs or drugs used outside the product license (e.g. for a new indication) (ICH-GCP). As per the internationally accepted ICH-GCP guidelines, clinical trials should be conducted strictly per the approved protocol. However, during the lifecycle of a trial, protocol deviations may occur. Under ICH efficacy guidelines, protocol deviations are divided into non-important (minor) or important (major), and the latter can jeopardise the participant's rights, safety or the quality of data generated by the study. Existing guidelines on protocol deviation management do not detail or standardise actions to be taken for participants, investigational products, data or samples as part of a holistic management of important protocol deviations. Herein, we propose guidelines to address the current literature gap and promote the standardisation of actions to address important protocol deviations in clinical trials. The advised actions should complement the existing local institutional review board and national regulatory authority requirements.

HPV vaccination acceptance and perceptions related to fertility and population control in the Gambia: An anthropological analysis.

This qualitative study using in-depth interviews and focus group discussions is the first to investigate HPV vaccination in The Gambia; it provides an in-depth analysis of uptake, knowledge, and perceptions of HPV vaccination as well as trust in Ministry of Health vaccination advice. Despite high uptake rates, knowledge of HPV vaccination was low, and the most prominent concern was that the vaccine could cause infertility or is a form of population control. Holistic approaches to addressing HPV vaccine concerns relating to fertility that consider socio-political contexts, including colonial histories, could lead to more positive vaccine perceptions, empowered decisions and to increasing vaccine uptake rates in The Gambia and elsewhere.

'We are always desperate and will try anything to conceive': The convoluted and dynamic process of health seeking among women with infertility in the West Coast Region of The Gambia.

INTRODUCTION: In many Sub-Saharan African countries, women with infertility search relentlessly for treatment. Guided by the Partners for Applied Social Sciences model for health seeking behaviour and access to care research, this study aims to understand the health seeking behaviour of women with infertility in the West Coast region of The Gambia and the influence of aetiological beliefs on health seeking paths. METHODOLOGY: A qualitative approach was used to generate both primary and secondary data for thematic analysis. The data collection methods included in-depth interviews (36), observations (18), informal conversations (42), group discussion (7) and made use of pile-sorting exercises. Sources of secondary data included government and non-governmental reports and media outputs. RESULTS: The health seeking approaches of women living in both rural and urban areas were extremely complex and dynamic, with women reporting that they looked for biomedical treatment as well as seeking indigenous treatment provided by local healers, sacred places and kanyaleng groups. While treatment choice was related to the perceived aetiology of infertility, it was also strongly influenced by the perceived effectiveness of the treatment available and the duration of the fertility problems. Other relevant factors were the affordability, accessibility and availability of treatment and respondents' family and social networks, whereby access to the biomedical health sector was strongly influenced by people's socio-economic background. CONCLUSION: On the basis of this analysis and our wider research in the area, we see a need for health authorities to further invest in providing information and counselling on issues related to infertility prevention and treatment. The availability of locally applicable guidelines for the management of infertility for both men and women at all levels of the health system would facilitate such work. In addition, the public sphere should provide more space for alternative forms of social identity for both men and women.