New collaboration seeks to address unique challenges facing clinical trials by applying key principles of good trials
Four major clinical trial networks based in low resource settings are embarking on an exciting partnership with the Good Clinical Trials Collaborative (GCTC) to enhance clinical research in low resource settings. By promoting the unique qualities of randomised controlled trials (RCTs) and the evidence they produce, the collaboration aims to support regional research ecosystems to prioritise collaborative, informative and efficient research responses to public health challenges.
ADVANcing Clinical Evidence in Infectious Diseases (ADVANCE-ID), Africa Health Research Institute (AHRI), Oxford University Clinical Research Unit (OUCRU), The Global Health Network (TGHN), and the GCTC coordinating centre at Protas, have formed Good Trials Prism. Supported and funded by Wellcome, Good Trials Prism will promote and implement the principles of good RCTs to strengthen clinical trials systems in Latin America, Southeast Asia, and South Africa.
These principles are outlined in GCTC’s Guidance for Good Randomised Clinical Trials and incorporated in the recently published draft guidance for best practices for clinical trials by the World Health Organisation.
Addressing challenges in low resource settings
Good Trials Prism is the first programme of its kind to put these principles into practice across a diverse range of geographies and health challenges, particularly focusing on their applicability to low- and middle-income countries – where there remains a high level of communicable disease and an increasing burden of noncommunicable disease coupled with limited research capacity and resources.
High quality, principles-based guidance can play a crucial role in mitigating these challenges by providing a robust platform for all stakeholders to focus their efforts effectively and work towards common goals.
A collaborative partnership
Central to Good Trials Prism is the development of education and training materials to promote understanding and adoption of the principles, openly available for others to utilise and benefit from. The programme will also undertake capacity strengthening, policy, advocacy, training and communications work, including delivering workshops, webinars, and training courses to promote sharing of knowledge and best practices.
The networks will play a leading role in promoting and implementing the principles in their respective regions by leveraging their local knowledge and existing relationships, tailoring resources to the needs of their research environments.
“Good Trials Prism is a fantastic platform to further our mission to promote and support high-quality clinical trials globally. By working together to apply the principles of a good trial as outlined in our guidance and now in WHO’s draft guidance, this partnership seeks to strengthen clinical trial systems and help overcome barriers in generating reliable evidence in low resource settings and across the world,” said Professor Sir Martin Landray, senior lead of the Good Clinical Trials Collaborative.
“We need trials that are more relevant, fair, and transparent in areas where improved treatments are urgently required. ADVANCE-ID, in conjunction with Good Trials Prism, is dedicated to delivering such trials to enhance patient outcomes and bolster public health,” said Dr Mo Yin, deputy director of ADVANCE-ID.
“AHRI is pleased to be a partner on this important project. Working in a rural, under-resourced setting means we are acutely aware of the challenges of running high-quality trials in such a context. We look forward to helping develop and strengthen clinical trials capacity in the African region so that the latest drugs, vaccines, and diagnostics can be safely brought to the people who need them most,” said Professor Limakatso Lebina, clinical trials lead and faculty member at AHRI.
“Being a part of Good Trials Prism allows institutions like OUCRU to share their vast expertise in clinical research and champion sustainable and equitable development of capacity in Southeast Asia. By embracing the principles of good clinical trials and working in tandem with other leading networks, we firmly believe we are well positioned to tackle the unique challenges facing clinical research and make a meaningful impact to health outcomes in this region,” said Evelyne Kestelyn, head of Clinical Trials Unit of OUCRU.
“Empowering researchers and healthcare workers to conduct high quality clinical trials in every healthcare setting with guidance, tools and support, will contribute to addressing the burden of diseases on health systems and save lives. This partnership is critical to ensure such resources are developed and implemented in contextually relevant ways and that all stakeholders may contribute to and benefit from these efforts,” said Professor Trudie Lang, head of The Global Health Network.
The name Prism underlines the key objectives of the programme – “PRomoting” and “Implementing” the principles of good RCTs with the aim of “Strengthening” clinical trial systems in low resource settings. Just like a prism, which refracts light into various components, the name also reflects the programme’s approach of applying the principles of good RCTs across multiple health challenges and diverse contexts.
Top photo: Prof Limakatso Lebina, clinical trials lead at Africa Health Research Institute.