The future of the global clinical trial ecosystem: a vision from the first WHO Global Clinical Trials Forum

• Published in: The Lancet (British edition) Vol. 403; no. 10422; pp. 124 - 126
• Main Authors: Moorthy, Vasee, Abubakar, Ibrahim, Qadri, Firdausi, Ogutu, Bernhards, Zhang, Wei, Reeder, John, Farrar, Jeremy
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 13.01.2024; Elsevier Limited
• Subjects: Best practice; Capacity development; Clinical medicine; Clinical trials; Clinical Trials as Topic; COVID-19; Design; Ecosystems; Ethics; Humans; Infectious diseases; Infrastructure; Maturity; Monitoring; Patients; Research ethics; Review boards; Self assessment; Sustainable development; World Health Organization; United Kingdom > UK
• ISSN: 0140-6736; 1474-547X; 1474-547X
• DOI: 10.1016/S0140-6736(23)02798-8

[...]those engaged in trials should use best practices for well designed and well implemented trials,10 including greater use of digital technologies and a more risk-proportionate approach to trial monitoring and oversight. [...]there is great scope to enable evidence generation by focusing resources on the key features of well designed and well implemented trials; accelerating timelines to ensure faster uptake of proven interventions that save lives and stopping the use of interventions that do not work or cause harm; and reducing costs. [...]to enable monitoring of capacity development progress towards a sustainable global trial infrastructure, a maturity framework for the clinical trial ecosystem should be developed based on the elements of best practices specified in the WHO guidance that is close to finalisation.10 For the maturity framework it will be desirable to build on existing self-assessment maturity tools for national regulatory systems and ethics oversight11,12 by establishing a clinical trial unit global maturity framework to support capacity development in this area. [...]national ecosystems should keep track of inefficiencies and monitor ways to improve them, for example through single Institutional Review Board and Research Ethics Committee models, ensuring parallel rather than sequential regulatory and ethics review, single submission systems for registration, regulatory and ethics review for multicentre studies, enabling importation of investigational products for key trials, and developing master clinical trials agreements to reduce the existing contracting delays.