В Гане запустили пилотный проект по оценке возможностей клиницических исследований при поддержке ВОЗ

The National Vaccine Institute (NVI), in collaboration with the World Health Organisation (WHO), is advancing a strategic initiative to strengthen Ghana’s clinical trials ecosystem. The partners will pilot WHO’s draft benchmarking tool for institutional capability for clinical trials. The initiative, supported by the European Union (EU) and other partners under the Vax & Pharm-Ghana Project, represents an important step towards building the institutional, scientific and operational capacity required to support high-quality clinical trials and Ghana’s broader vaccine research, development and manufacturing agenda. Clinical trials are an indispensable part of the health-product development pathway, generating the scientific evidence required to establish the safety and effectiveness of vaccines, medicines and other interventions. For Ghana, developing a strong clinical trials ecosystem is, therefore, central not only to research excellence, but also to health security, innovation, vaccine self-reliance and the development of a sustainable domestic pharmaceutical manufacturing ecosystem. A statement from the NVI said piloting the draft WHO benchmarking tool for institutional capability for clinical trials would provide a structured, evidence-informed approach for clinical research institutions to assess their capabilities, identify strengths and gaps, and prioritise areas for institutional development. “The tool focuses on the enabling systems required for consistently high-quality, ethical and efficient clinical trials rather than simply measuring the number of studies undertaken,” the statement said. It said the pilot would examine institutional capability across seven functional areas, including patient and community engagement, scientific concepts and research design, and responsibilities to ethics and regulatory oversight bodies. The rest are data management, informatics and statistics; clinical trial operations and management; leadership, communication and teamwork; and institutional infrastructure and systems. “These areas comprise 32 functional objectives and 112 specific outcomes that enable institutions to systematically examine the systems supporting clinical trials in Ghana,” the NVI said. Implementation As part of the collaboration, the NVI and WHO have convened participating institutions in the Volta Regional capital, Ho, for an interactive training workshop. During the workshop, the institutional teams were introduced to the purpose and indicators of the benchmarking tool, trained to use the pilot application, and supported to organise teams with defined responsibilities for undertaking the self-assessment. Following the training, institutions commenced a self-assessment process, reviewing available evidence against the benchmarking indicators and documenting their experiences with the tool. The next phase brought the participating institutions together for a focused technical dialogue with NVI and WHO. The discussions examined challenges encountered in interpreting indicators and collecting evidence, identified opportunities to improve the tool, and considered how institutional benchmarking can be effectively implemented within Ghana’s clinical trial environment. Importantly, the exercise was a capacity development and continuous-improvement process that allows institutions to understand their existing capabilities and identify practical investments needed to strengthen governance, workforce, research processes, data systems, participant protection, infrastructure and institutional quality management. Beyond strengthening individual institutions, the collaboration presents an opportunity to build a more coordinated and resilient national clinical research ecosystem. National coordinating institutions can leverage the benchmarking findings to identify common capacity gaps, facilitate peer learning, align investments with national health research priorities and reduce fragmented capacity-building efforts. They can then progressively integrated a culture of continuous quality improvement across the clinical trials landscape. The statement said the exercise was also crucial for effectively mapping and matching institutional strengths to the requirements of multi-centre clinical trials in Ghana, thereby enabling more strategic collaboration, efficient resource utilisation, and stronger national research capacity. Govt commitment Speaking at the training, the Deputy Minister of Health, Dr Grace Ayensu-Danquah, reaffirmed the government’s commitment to strengthening Ghana’s clinical trial capacity as the country worked towards achieving end-to-end vaccine production. She situated the workshop within Ghana and Africa’s broader push for health sovereignty, saying, “True health sovereignty depends on the less visible groundwork systems, policy, and institutional capacity that precede actual vaccine production. Clinical trials conducted elsewhere do not always serve African populations well.” Dr Ayensu-Danquah also stressed the importance of regional collaboration and proposed a model of African “centres of excellence” in which countries specialise in products or capabilities and trade with one another, rather than each country attempting to produce everything independently. The Chief Executive Officer of NVI, Dr Sodzi Sodzi-Tettey, framed the exercise as a critical step in the institute’s phased approach to building Ghana’s vaccine manufacturing capability. “We are starting with fill-and-finish as a practical entry point, with the long-term goal of full end-to-end manufacturing,” he explained. Dr Sodzi-Tettey said the expertise gathered at the workshop represented the enormous brain power the country needed “to map our institutional capability gaps and begin closing them.” The Technical Officer for Integrated Service Delivery, WHO Country Office, Dr Angela Ackon, who represented the WHO, also affirmed the significance of the partnership: “This benchmarking exercise gives Ghanaian institutions a structured, evidence-based way to understand their own capabilities and chart a clear path for improvement.” She said WHO was proud to stand with the NVI and the government of Ghana “in this important step towards a stronger, more resilient clinical trials ecosystem.”