Global women’s health: Current clinical trials in low and middle-income countries. Merriel A, Harb HM, Williams H, Lilford R, Coomarasamy A

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Scenario During an international women’s health conference, a keynote speaker gave an overview of current clinical trials in low-and middle-income countries (LMICs). At the end of the plenary, she asked “how can we improve research in global women’s health after the era of Millennium Development Goals (MDGs)?”

Background Globally many scientists are striving to develop a robust evidence base to improve women’s healthcare A clear overview of this research will enable: Better collaboration Less duplication Opportunities to target research investment geographically and topically

Background What are Sustainable Development Goals (SDGs)? What are the differences between MDGs and SDGs? Which SDG is particularly relevant to women’s health?

The Question What are the characteristics of currently active clinical trials investigating women’s health in low and middle income countries?

Description of Research ParticipantsAll active randomised trials in LMICs registered on the WHO International Clinical Trials Registry Platform (ICTRP) between 1 April 2012 and 31 March 2014 InterventionTrials of women’s health interventions or with a significant outcome for women ComparisonNot applicable OutcomesNumber of trials, their geographical spread, study size, speciality areas and sources of funding, and whether the trials were registered pre-enrolment DesignReview of the WHO ICTRP database

Methods A systematic review of an international (WHO) meta-registry of clinical trials Using broad search terms to identify active studies with a focus on obstetric or gynaecological topics Categorising studies into specialty areas Identifying topical, geographical and financial trends

Where is research being conducted?

What is the clinical focus of trials?

Results Summarise the geographical spread and study size of the reported studies. How do they influence the implementation of research findings? What are the potential benefits and pitfalls of the observed differences between women’s health research in low-income countries (LICs) and middle-income countries (MICs)?

Other results Nearly half (46%) of trials are registered after enrolment Most trials recruit <500 participants Sources of funding: – In low income countries, 83% of trials are funded by international donors – In middle income countries, 72% of trials are funded by local hospitals and academic institutions Research topics – In low income countries, 83% of trials are focused on obstetric topics – In middle income countries, 40% of trials are focused on obstetric topics

Results The authors recognise that a proportion of trials were missed by the WHO ICTRP. How could we tackle this problem? Only half of the trials were registered before enrolment. Why is pre-enrolment registration important?

Discussion How can we improve women’s health research in LMICs after 2015 based on the results of this study?

Authors’ conclusion Research into women’s health is active in every region across the world The research agenda in low income countries is determined mostly by international funders Many trials are not registered prior to recruitment Prospective registration could enhance collaboration and improve the quality of evidence

Suggested reading Sustainable Development Knowledge Platform. The Millennium Development Goals. The World We Want An online platform to view and contribute to the global discussion on the Post-2015 Development Agenda. Core Outcomes in Women’s Health (CROWN) The AllTrials campaign.

Funding AM is part-funded by Ammalife ( UK registered charity no ).