Katharine Wright et al.
Emergencies in public health resulting from either new or recurring infectious diseases necessitate swift answers regarding the efficacy of medical countermeasures. Traditional trial designs, as observed in previous pandemics, struggled to deliver results promptly enough to support effective responses. An encouraging solution lies in adaptive platform trials, which employ a master protocol across multiple sites, incorporate numerous intervention arms, and utilize adaptive methodologies. Noteworthy examples of such trials, including RECOVERY, Solidarity, PRINCIPLE, and REMAP-CAP, played a pivotal role in the global research response to COVID-19. Their substantial scale and flexible capacity to add or remove arms based on emerging information facilitated the rapid generation of evidence on the effectiveness of both repurposed and novel interventions for COVID-19, ultimately saving numerous lives. Crucially, these trials also swiftly provided evidence indicating ineffectiveness of some widely-used interventions, thereby minimizing harm to patients and reducing unnecessary costs for health systems.
Questions raised by the reviews
- What lessons can be drawn from COVID-19 adaptive platform studies to enhance the ongoing integration of ethics into project management processes?
- How can meaningful involvement of researchers, public health officials, communities, and other essential stakeholders in Low- and Middle-Income Countries (LMICs) be ensured in the planning and implementation of adaptive platform trials to establish equitable partnerships?
- What were the factors that facilitated or hindered Good Participatory Practice (GPP) in significant COVID-19 adaptive platform studies, and how can this inform the development of revised guidance for GPP within the context of adaptive platform trials?
- How can researchers be supported and incentivized to thoroughly document and report on the outcomes and experiences of community engagement, with the aim of strengthening best practices?
- What information is appropriate to convey to participants regarding the adaptive features of trials to facilitate informed consent, and how can this information be effectively communicated, especially during an infectious disease outbreak?
- What challenges and experiences did research ethics committees and data safety and monitoring boards encounter in reviewing protocols and data for adaptive platform studies during COVID-19, and how can these committees be better supported in the future?
- What evidence exists regarding the benefits to less well-resourced countries from their involvement in adaptive platform trials, including any impact on medical practices, improvements in health outcomes, or advancements in research capacity?
Conclusion
Large multi-country adaptive platform trials organized by global research networks are poised to become significantly more influential in both urgent and routine research. Securing funding for these extensive networks inevitably requires sacrifices in terms of other research areas and institutions not participating in these networks. The article emphasizes the importance of addressing crucial ethical concerns related to power dynamics, fairness, and consideration for local circumstances and requirements across the entire research ecosystem as it advances these impactful research models.
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