How funders can support improved clinical trial practice for outbreaks

The World Health Assembly's resolution 75·8 on strengthening clinical trials is a call to action to improve the quality and coordination of trials globally.1WHOStrengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination.https://apps.who.int/gb/ebwha/pdf_files/WHA75/A75_ACONF9-en.pdfDate: May 24, 2022Date accessed: May 1, 2023Google Scholar Large-scale, sufficiently powered trials are important in the context of outbreak response, when opportunities to gather evidence for clinical management are scarce. During the COVID-19 pandemic, the health system witnessed success in the rapid initiation of adaptive trials that generated life-saving results, but also a proliferation of competing, underpowered trials that were concentrated in high-income settings.2Bugin K Woodcock J Trends in COVID-19 therapeutic clinical trials.Nat Rev Drug Discov. 2021; 20: 254-255Crossref PubMed Scopus (56) Google Scholar For an effective and equitable response during the next pandemic, change across the clinical trial ecosystem is needed to coordinate efforts towards well designed trials that are implemented at scale. Research funding agencies have a key role in deciding both how and what they fund.3Department of Health and Social CareG7 therapeutics and vaccines clinical trials charter.https://www.gov.uk/government/publications/g7-health-ministers-meeting-june-2021-communique/g7-therapeutics-and-vaccines-clinical-trials-charterDate: June 4, 2021Date accessed: May 1, 2023Google Scholar, 4Pandemic Preparedness Partnership100 days mission to respond to future pandemic threats.https://www.gov.uk/government/publications/100-days-mission-to-respond-to-future-pandemic-threatsDate: June 12, 2021Date accessed: May 1, 2023Google Scholar The Global Research Collaboration for Infectious Disease Preparedness (GloPID-R) has been working to improve coordination between global funders since 2013.5Matthiessen L Colli W Delfraissy J-F Hwang E-S Mphahlele J Ouellette M Coordinating funding in public health emergencies.Lancet. 2016; 387: 2197-2198Summary Full Text Full Text PDF PubMed Scopus (11) Google Scholar On the basis of previous experiences and extensive consultation, the GloPID-R Funders Living Roadmap for Clinical Trial Coordination was developed to support implementation of the World Health Assembly's clinical trials resolution. Our roadmap identifies three key goals supported by eleven principles, and recommends actions to support funders in achieving the goals. The first goal is to support clinical trial networks and platforms to strengthen their readiness to rapidly respond to outbreaks. This aim can be achieved by providing the long-term funding needed to maintain research infrastructure, addressing regulatory and contractual challenges, and sustaining trusted relationships. Funders can also promote good clinical trial practice by including grant conditions that embed best practices on the harmonisation of well designed trial protocols, standardised data collection, data sharing, and community engagement. The second goal is to improve coordination across research funding agencies to facilitate a coordinated, agile, effective, and equitable clinical trial response. Funders can deduplicate and synergise investments through funding transparency throughout the grant call-cycle or by jointly funding trials. Individually, funding agencies can also adapt their policies and practices to support the pivot and surge of research capacity towards novel research questions. The final goal is to promote an equitable research environment. Funders can have a key role in facilitating equitable partnerships and governance for clinical trial research globally through their policies and provision of the support necessary for leading and implementing trials worldwide. We are confident that the implementation of the GloPID-R Funders Living Roadmap for Clinical Trial Coordination will improve global capacity to generate high-quality evidence to inform clinical and public health responses and outcomes during disease outbreaks. We declare no competing interests. GloPID-R Clinical Trial Networks and Funders Working group members are listed in the appendix. Download .pdf (.14 MB) Help with pdf files Supplementary appendix