An impact-driven, outcome-guided, priority-based, and ethically conducted health research agenda in Africa urgently needs a standardised approach to health research prioritisation, a pan-African health research workshop that took place in Addis Ababa, Ethiopia, from November 21-23, 2024, heard.
African-centred health research ethics that respect cultural values and the diversity of the African context, and a continental governance and coordination framework that ensures harmonised research efforts to address the priorities of affected populations within communities, are required.
Africa CDC has been developing key frameworks to guide the process of setting national health research priorities for the continental research agenda. Using Lassa fever research in West Africa as a proof of concept for harnessing local capacity for high-quality research, it has now expanded efforts to map the research landscape for capacity strengthening across Africa.
Dr. Nebiyu Dereje, Senior Science Writer at Africa CDC, told the meeting that Africa CDC is developing a tool to assess the research capacity and capabilities of research centres, the findings of which will guide the development of a roadmap for research capacity strengthening capable of addressing priority health problems in Africa.
Up to 90% of medications and 99% of vaccines in most African Union Member States are imported. The continent accounts for barely 3% of all medicines produced globally. As Africa CDC advocates for local manufacturing to address this gap, there is a need for robust capacity for research and development as a basis for harmonised local health manufacturing, hence the capacity mapping initiative.
"We plan to comprehensively assess the research capacity and capabilities of research sites in Africa," said Dr. Dereje. "The findings of this mapping will be pivotal in strengthening the continent's research capacity."
Mapping Africa's research landscape entails cataloging all centres engaged in basic science, clinical trials, epidemiological research, and other relevant areas. Research centres will be assessed and ranked considering their strengths and areas for improvement. "We will evaluate the availability and expertise of personnel dedicated to research, focusing on skills, training, and specialization," said Dr. Dereje. "We will determine the extent to which basic and preclinical research findings are translated into clinical applications, including at least Phase I clinical trials," he added.
The assessment will extend to identifying key national and international stakeholders, including academic institutions, funding agencies, and governmental bodies involved in health research. The researchers will also examine the ethical and regulatory structures governing research at these centres, ensuring compliance with national and international standards and best practices.
Dr. Dereje said research sites in all member states will be assessed, leveraging Africa CDC's in-country presence through face-to-face interviews using an electronic semi-structured questionnaire hosted on secure servers at Africa CDC. The questionnaire will deep-dive into the outlook of the site, scope, area of focus, research infrastructure, scientists, research project experience, research outputs and impacts, resources and networks, ethics and regulatory frameworks, and health research legislation. Analysis of this data will result in creating an "online data repository and dashboards to facilitate identification and harnessing of research capacity," he said.
Research Prioritisation for the African Research Agenda
Dr. Elvis Temfack, Head of Research & Development and Clinical Trials Coordination at Africa CDC, said that they have been in the process of developing a prioritisation framework for health research in Africa.
The development of this framework was guided by existing frameworks within the African Union, among them the Africa Health Strategy 2016-2030, which says: "Member states should encourage locally driven and financed research through empowerment of local research institutions, setting up innovative hubs and allocation of 1% of national GDP for research and innovation." There is also support from the Health Research and Innovation Strategy for Africa 2018-2030, which aims to integrate health research and innovation into Africa Health Strategy and serve as a guide for priority setting as well as stakeholder alignment with Africa's health research and innovation strategy.
Dr. Temfack said research prioritisation is necessary because resources for health research are scarce, and the majority of the current funding for research in Africa comes from partners, most with strict directives that address the partner's interests. While Africa Health Strategy 2016-2030 calls for 1% of GDP to be invested in research and innovation, most countries are not close to achieving this yet, he said. He said the goal of the framework is to ensure that health research by African stakeholders identifies research questions whose findings will drive the greatest possible impact on health outcomes.
"The objective is to develop and operationalize a framework to guide the practice of research prioritization within African Union member states that addresses the health needs of the end-users of research outcomes within the African context," Dr. Temfack said.
The pathway to develop the prioritisation framework included an online survey in 2023 sent to key stakeholders to evaluate personal preferences on criteria for research prioritization along the spectrum of disease as guided by the Africa CDC mandate, face-to-face consultative meetings with stakeholders to evaluate and critique the selected criteria along many aspects, and develop relative weighting of the different attributes of the criteria through a discrete choice experiment and conditional utility model analysis, he said. The weightings of the attributes of each criterion have been used to develop an online research prioritisation tool, to be hosted on Africa CDC servers, that will accompany the prioritisation process within Member States, ensuring the process of setting national research priorities is evidence-based using locally generated data of the Member State through an inclusive multi-stakeholder approach.
African-Centred Health Research Ethics During Emergencies
In 2023 alone, over 166 public health outbreaks were reported in Africa, an average of 3 events every week. Research as a response to these outbreaks requires the efficient generation of robust evidence during the outbreak. However, within an emergency context, most research participants are vulnerable and therefore at risk of research misconduct. As such, during outbreaks and emergencies, research must be ethically conducted respecting local cultural values and protecting research participants within their context. "However, most codes and regulations guiding clinical research in Africa are imported and adapted, and there is a need to adhere to contextual and cultural diversity of the African Continent," said Dr. Temfack, who is also leading the development of the African-centred research ethics framework during outbreaks and emergencies.
He noted historical incidences of violations of ethical conduct in research. Research approaches encompassing "helicopter" research and ethical dumping in Africa require consideration of African cultural values to ensure that research participants within communities understand the value of research in health within the local context. This framework, whose aim is not to undermine existing ethical frameworks guiding research, seeks to ensure that African values are considered within these international guidelines.
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The Next Steps
Dr. Mosoka P. Fallah, Acting Director of Science and Innovation at Africa CDC, said there is a need to support the development of sustainable clinical trial capacity. Currently, he said, funding of clinical research capacity is partner-driven and project-specific. Grant-based North-South funding creates dependencies and makes the development of alternative business models difficult because of a lack of local ownership, and regional guidance capabilities at research entities are often not sustained. He said many countries have very few opportunities to develop their own, independent outbreak preparedness strategies.
Dr. Fallah said emergency evidence generation in future epidemics and pandemics must be coordinated on a continental and regional level while clinical research entities must grow to competitive institutions and develop their own business models to become independent from project-specific funding. Competition among funders must be reduced, and coordinated joint efforts to support the African clinical trial ecosystem are needed. Clinical trial sites need a transparent platform to promote their capacities and experience and establish direct links to industry partners, he said. A pilot prioritisation and mapping tool in Ghana and Togo was initiated from November 25 to December 16, 2024. A post-mortem analysis of the pilot meeting to refine it for rollout to other member states is set for February. The rollout of prioritisation mapping in the remaining 53 member states is scheduled for March 2025. Dr. Fallah said a regional scientific advisory group is expected to be launched next year and the continental ethics review committee will be set up during the same period.
