As Dr Makanga noted: “The World Health Organisation guidance provides a global framework for improving clinical trial infrastructure and creating an enabling environment to enhance the conduct and timely reporting of well-designed trials to well-maintained, accessible and curated clinical trial registries.”
Dr Makanga also noted that the guidance includes the importance of consultation with patients, healthy participants and communities, as well as of addressing the needs of underserved populations. Importantly, the guidance was inclusively developed with input from a wide range of stakeholders both high-income and low- and middle-income countries, and covers all kinds of trials, academic and commercial.
Guidance development
Dr Vasee Moorthy (WHO) described some key features of the global guidance and an associated global action plan (extensively described in a series of articles in Lancet Global Health). He also noted that the African region had many existing strengths in this area, including strong international networks and regional initiatives, regional funding streams, AVAREF (a regional body supporting regulatory capacity building and harmonisation), a track record of impactful trials, outstanding clinical researchers, and excellent community engagement.
The WHO guidance and global action plan have been developed through a bottom-up approach with extensive consultation. Guidance aligns with ICH guidance but goes into more detail in several areas. It includes a section on improving clinical trial systems which provides guidance to governments. It covers four pillars – governance, infrastructure and community engagement, ethical review, and regulation. A maturity level system already exist for regulatory authorities and a tool is being developed to support benchmarking of clinical trial units.
The global action plan covers nine areas and provides a comprehensive approach to enhancing clinical trial capabilities around the world. These areas include:
- National leadership and commitment.
- Community engagement.
- Inclusion of under-represented populations.
- Innovative designs and digital technologies.
- Training.
- Streamlined approvals.
- Integrated trials.
- Enhancing trial registries.
- Boosting international collaborations.
Various groups around the world are developing activities to progress each of these areas.
Dr Moorthy noted that research ethics overview could be a rate-limiting step in oversight systems. Strengthening of research ethics committees is essential, alongside enhanced coordination between regulatory and ethics review systems.
He concluded by noting some key general issues for clinical trials, including the need to focus on priority questions and evidence gaps, to shift to a risk-based approach in regulatory oversight, the importance of patient and community engagement, and the need to make best possible use of clinical trial evidence.
Moving the agenda forward
Dr Makanga then introduced a panel discussion, with representatives from different sectors and different parts of Africa discussing some of the implications of this work.
Dr Kwasi Nyarko (AVAREF Secretariat, WHO Regional Office for Africa, Republic of Congo) noted the need to adapt the global guidance to the regional context, which AVAREF has begun working on. AVAREF’s work is built on three pillars – partnerships, technical support for countries, and an end-to-end perspective that considers the whole R&D ecosystem. He highlighted the progress that has been in the region since AVAREF was set up two decades ago, when just 30% of countries had a national regulatory authority. Tailored capacity building according to country needs is essential to maintain this momentum, he suggested.
Dr Glaudina Loots (Department of Science and Innovation, South Africa) agreed that it was an exciting time for the region, and suggested that collaborations could accelerate progress. She suggested that there were opportunities for countries in the region to learn from one another.
Victor Chalwe (National Health Research Authority, Zambia) emphasised the importance of having a strong legal framework to underpin clinical trials in countries. In addition, identifying local priorities could help to promote greater local financing of research and implementation of plans to create a supportive environment for clinical trials in countries.
Dr Eric Remera (Rwanda Biomedical Centre) highlighted some of the remarkable progress that has been made in Rwanda, which has demonstrated the importance of high-level political commitment. An assessment of clinical trial infrastructure has identified gaps that need filling, and efforts are being made to embed research within the health system and to establish hospital networks to support multisite studies. An integrated system has been developed for regulatory and ethical review submission and short timeline targets have been specified. Rwanda’s nascent national medicines authority has already achieved maturity level 3 status and a digitalisation plan is being implemented, which Dr Remera suggested could facilitate post-marketing studies.
John Amuasi (Kwame Nkrumah University of Science and Technology, Ghana) noted that Ghana also had a well-developed national regulatory authority, but suggested that its ethics review systems were not so well developed. There were also opportunities to enhance coordination across the two areas. He also suggested that the costs of clinical trial submissions could be prohibitively high, which could be a barrier to the development of local clinical trial applications.
In follow-up discussions, Dr Loots suggested that the reductions in funding from external sources could eventually prove a blessing in disguise. She argued that there was a need to transition to domestic funding, which would help to ensure that research activities were always driven by local needs and priorities. She suggested that the South African Government had already begun to invest more in infrastructure and trials. There is now an opportunity to take a more strategic approach and define an African-led research agenda focused on locally determined challenges and priorities.
In addition, Dr Amuasi noted the increasing complexity of clinical trials, particularly the growth of more efficient adaptive trials. There are opportunities for more innovative trial design in Africa, which will require capacity to be built in protocol development. Furthermore, it is still relatively rare for African institutions to take on the role of clinical trial sponsor. Infrastructure and intellectual capacity will need to be built if African institutions are to take on more responsibilities for trial sponsorship.
Comments from the floor included the key point that it can be difficult for trial sites and networks to continue once projects end, and models that ensure long-term sustainability are needed. It was also suggested that a forum for political engagement was needed, which could emphasise how little drug manufacturing takes place in Africa. Finally, it was noted that there had been much country and regional input into the guidance, and it was now important for all parties to own the document and to work cooperatively on its implementation.