CIOMS cited

Clinical trials are considered as a robust study design to establish which therapeutic interventions including vaccine discovery and developments, and diagnostic tests are most applicable to the public. However, there are many ethical implications of conducting clinical trials in low- and middle-income countries (LMIC). The authors adapted the methodology of an umbrella review to delineate the evidence regarding the ethical considerations on clinical trials in LMIC.

Dengue, a mosquito-borne viral disease, is undergoing its largest surge in history, driven by climate and demographic changes. Expanding transmission has highlighted previously under-recognised populations at heightened risk of severe disease, including people with multimorbidity and immunosuppression, for whom live-attenuated vaccines are contraindicated or unlicensed. This evolving epidemiology underscores the urgent need for safe and effective treatments for dengue, particularly for those with complex risk profiles compounded by socioeconomic disadvantage. The authors examined ethical, regulatory, and implementation considerations to support WHO target product profile development for dengue therapeutics. Their analysis highlights the need for better characterisation of groups at risk through approaches such as enhanced surveillance; co-produced approaches for the inclusion of these groups in research prioritisation, trials, and care; and strategies to address key barriers to access for all, such as rapid diagnostics. This framework can potentially inform equitable development and delivery of countermeasures for other infectious disease threats to global health.

Effective project management is crucial for the successful execution of complex health research initiatives, particularly those involving multiple stakeholders and ethical considerations. This paper illustrates how applying a PMBoK-based framework to the "Active Pregnancy" project enhances planning and coordination, ultimately providing a transferable model for managing similar multidisciplinary health research projects.

Fluid overload in critically ill patients with acute kidney injury (AKI) is independently associated with increased mortality, prolonged mechanical ventilation and impaired renal recovery. Net ultrafiltration (UFNET) during continuous renal replacement therapy (CRRT) is a cornerstone de- resuscitation strategy; however, tolerance to fluid removal is highly variable and difficult to predict. Ultrafiltration intolerance, encompassing haemodynamic instability, peripheral perfusion deterioration and tissue hypoperfusion during UFNET, lacks a standardised definition and has not been prospectively evaluated using a comprehensive multiparametric monitoring strategy. The Volume removal Intolerance during Net ultrafiltration in acute Kidney injury patients, an Observational study (VINKO) aims to identify clinical, haemodynamic, ultrasound-based, perfusion- related and biochemical factors associated with the development of ultrafiltration intolerance in critically ill patients with AKI undergoing CRRT.