A roadmap for fostering timely regulatory and ethics approvals of international clinical trials in support of global health research systems.

Abstract

The global clinical research ecosystem faced highs and lows during the COVID-19 pandemic. Key issues included research waste from poor-quality trials and fragmented regulatory and ethical reviews. Streamlining and harmonising these review processes is crucial for efficient, robust, and timely multinational trials, ensuring rigorous scientific standards, proper safety, and ethical oversight. Robust regulatory and ethics review systems thrive on continuous learning and efficient processes, crucial for high-quality research. Enhancing trial design and implementation, and guiding innovative approaches including decentralised trials and patient-centric designs are essential for the regulatory and ethics authorities to advance public health. These approaches are built on the principles of global guidance outlined in International Coalition for Harmonization Good Clinical Practice guidelines and the WHO guidance for best practice for clinical trials. To realise the agreed vision at the first WHO Global Clinical Trials Forum in 2023, a panel of international experts in clinical research, including representatives from national and regional regulatory and ethics authorities, proposes key actions to improve coordination and streamlining of regulatory and ethics review. The actions emphasise: leveraging existing trial networks and capacity-building initiatives; advancing joint and parallel regulatory and ethics reviews and single national ethics review; improving transparency on approval requirements; simplifying and standardising informed consent forms and processes; and developing mechanisms to improve efficiency for trial site contracting as well as exportation and importation of investigational products for trials. The proposed actions for the reform are urgent and key to generate evidence to enable access to safe and effective interventions for populations most in need.