Enhancing global clinical trial transparency for better health outcomes for all
Zhang W., DeVito N., Chan A-W., Cunningham C., Pymento J., Karam G., OWUOR J., Moorthy V.
Background: In 2022, WHO’s World Health Assembly adopted resolution WHA75.8, emphasizing the critical role of clinical trials in generating high-quality evidence and promoting equitable access to health interventions globally. In response, rapid landscape reviews were conducted to assess global clinical trial regulations, capacities, and funding distribution. Methods The analysis synthesized regulatory frameworks from 94 countries, institutional capacity data from the WHO International Clinical Trial Registry Platform (ICTRP), and funding data from World RePORT for trials registered between 2018-2022. Gaps in data availability and quality were assessed. Results Most countries reference international ethical guidelines, with universal requirements for ethics approval and informed consent. However, only 66% mandate public trial registration, and 40% require results reporting, with stark disparities between high- and low-income countries. High-income countries host over half of global trials; low-income countries contribute less than 1% despite high disease burden. Clinical trials sponsored by non-commercial entities are particularly scarce in low- and middle-income countries. Funding remains concentrated in the Americas and European regions, primarily driven by major funders such as the National Institutes of Health in the United States of America and European Commission. Significant data accessibility challenges persist due to incomplete registry records, inconsistent standards, lack of harmonized identifiers, and limited bulk data access. Recommendations Urgent actions include reinforcing international standards for trial registries, harmonizing data fields, improving registry interoperability, leveraging unique identifiers, enhancing multilingual accessibility, auditing data quality, pooling analytical resources, promoting open data policies, and investing in registry infrastructure and trained personnel. Conclusion Addressing data gaps and inequities in clinical trial ecosystems requires concerted action by global stakeholders. Improved data transparency and interoperability are essential to guide equitable research investments, foster coordination, and strengthen clinical trial capacity worldwide.