Gavi

Minimal residual disease (MRD) is a central biomarker in multiple myeloma (MM), offering unprecedented sensitivity for evaluating treatment efficacy and serving as a potential surrogate endpoint. We conducted a comprehensive analysis of clinical trials registered on ClinicalTrials.gov between 2014 and 2025. Interventional trials or observational studies investigating therapeutic interventions were included. Data on therapy response, MRD outcomes, measurement, and their role as primary, secondary, or adaptive endpoints were extracted. A total of 1336 studies met inclusion criteria. Among interventional trials, 86.4% included therapy response and 30.9% MRD as an outcome. Trials assessing MRD increased steadily from 6.7% in 2014 to 56.8% in 2025. Almost 50% of trials with recruiting (46.0%) or not yet recruiting (46.8%) status had an MRD outcome. MRD served as a primary outcome in 28.4% of trials with MRD assessment and guided therapeutic decisions in 7.5%. Most studies used next-generation flow or sequencing at a 10-5 threshold, though reporting heterogeneity persisted. MRD integration in trials has expanded substantially, reflecting its clinical and regulatory importance. Still, there is a need for coordinated evidence generation, standardization, and alignment with evolving EMA and HTA requirements. Future research should integrate patient experience data and emerging non-invasive MRD technologies to enhance clinical relevance and policy acceptance.

ABSTRACT Previous studies have shown that facility autonomy, especially control over budget allocation, and management practices can have a modest positive effect on health facility performance, but the evidence is limited and often qualitative. Data from the evaluation of the Nigeria States Health Investment Project (NSHIP), a study that examined the effects of direct facility and performance-based financing, offers a novel opportunity to quantitatively examine these relationships in the context of a lower middle-income country. We utilize non-parametric statistics and regression methods to test the hypothesis that autonomy, supervision, and management affected facility performance. Results show that facilities with greater autonomy, more budget control, and better management practices generally outperform their peers on a range of facility readiness and service delivery measures. For example, regressions show that facilities with high autonomy held an additional 2.1 outreach sessions per month and facilities with a business plan offered 1.8 additional outreach services (p < 0.05). Supervision practices, including visit frequency and a quantitative checklist, are associated with 26% higher productivity and up to a 29% increase in equipment availability (p < 0.05). Sensitivity analyses validated that results are robust. We conclude that facility-level autonomy and especially budget control can improve primary healthcare facility readiness and service availability. Further, management practices that are reinforced through supportive supervision and routine monitoring can maximize the benefits that accrue from even small amounts of incremental financing. This shows that these policies and practices can contribute critically to efficiently achieving the goals of universal healthcare policies in the context of limited resources.

A common misconception that prevails within some research communities postulates that research results 'speak for themselves' and are thus sufficient to influence policy. Yet, high-fidelity uptake of research is rarely a passive process; more often, researchers need to actively engage with policymakers. This process of policy engagement strives towards producing robust science that contributes to the betterment of our societies-but it is a process for which many researchers are not adequately trained. If publicly funded research fails to influence policy, many would regard it as falling short of fulfilling its potential value to society. Herein, we provide a framework for research-policymaker engagement, framed around the questions of why, on what, with whom, when, where and how clinical and public-health researchers can and should undertake engagement with policymakers. The views presented in this Perspective are a synthesis of the diverse, collective experience of the authors across global health contexts, supported by real-world illustrative case studies. We provide tangible recommendations for researchers, funders and policymakers to facilitate bridging the gap between evidence and policy.

Abstract Background The availability of essential medicines and supplies remains a serious impediment to effective primary health care (PHC) in many lower and lower middle-income countries. Most of these countries rely on centralized procurement, centralized stores, and a “push” distribution system. We describe here the impacts of a large-scale randomized trial in Nigeria, which provided modest funding directly to facilities to spend, on supply availability. Methods Districts in three states were randomly allocated to either direct facility financing (DFF) or performance-based financing (PBF) and matched to a control group. Both DFF and PBF transferred funds to facility bank accounts and allowed the facility management committee to spend on operational costs, including essential drugs. Facilities could procure medicines on the government’s essential drug list from pre-approved suppliers if they were certified by the national drug regulator. We conducted a difference-in-difference (DiD) analysis using facility survey data to assess the impact on availability of essential drugs and supplies. Results Drug availability was initially similar for the three arms of the trial (9 of 29 essential medicines). After three years, DFF and PBF facilities had significantly higher product availability than control (p&lt;0.05). This amounted to an increase of 28/ 34 percentage points in DFF/PBF facilities (an additional 8/10 products, respectively), and only 10% in control (3 additional products). We did note that there was little difference between control and intervention arms in the availability of medicines for donor-supported vertical programs like immunization, family planning, and malaria. However, there were very large improvements for products like antibiotics, obstetrical drugs, diagnostics, and TB medications. Conclusion Providing funds directly to health facilities improved drug availability. It was superior to the typical centralized procurement and “push” distribution system that is widespread in lower-income settings. This approach is already spreading and should be adopted more widely.

Background: Residual blood specimens offer a cost- and time-efficient alternative for conducting serological surveys. However, their use is often criticized due to potential issues with the representativeness of the target population and/or limited availability of associated metadata. We conducted a scoping review to examine where, when, how, and why residual blood specimens have been used in serological surveys for vaccine-preventable diseases (VPDs) and how potential selection biases are addressed. Methods: The review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guidelines and identified relevant papers published in 1990-2022. Results: A total of 601 articles met the inclusion criteria after title, abstract screening, and full-text review. The most studied VPDs using residual blood specimens were COVID-19 (27%), hepatitis E (16%), hepatitis B (10%), influenza (9%), HPV (7%), and measles (7%). Residual blood specimens were primarily sourced from diagnostic specimens (61%) or blood and plasma donations (37%). Almost all articles used specimens linked to basic demographic data (e.g., age and sex), with 47% having access to extended demographic data (e.g., geographic location). Common strategies to address potential biases included comparing results with published estimates (78%) and performing stratified analyses (71%). Conclusions: Residual blood specimens are widely used in seroprevalence studies, particularly during emerging disease outbreaks when rapid estimates are critical. However, this review highlighted inconsistencies in how researchers analyze and report the use of residual specimens. We propose a set of recommendations to improve the analysis, reporting, and ethical considerations of serological surveys using residual specimens.

Previous studies have shown that facility autonomy, especially control over budget allocation, can have a modest positive effect on performance, but the findings depend on the context. Similarly, management practices are often cited as important contributors to facility performance, but the evidence is limited and usually qualitative. Data from the large-scale randomized evaluation of the Nigeria States Health Investment Project (NSHIP) offers an opportunity to quantitatively examine these relationships in the context of a lower middle-income country. We utilize non-parametric statistics to test for difference in means and apply regression analysis to test the hypothesis that autonomy and management affected facility performance. Our results show that facilities with greater autonomy, more budget control, and better management practices generally outperform their peers on a range of facility readiness and service delivery measures. For example, regression results found that facilities with high autonomy held on average 2.1 more outreach sessions per month than those without, and facilities with an annual business plan offered 1.8 additional outreach services. Supervision practices, such as more frequent visits and use of a quantitative checklist, are associated with 26% higher productivity and up to a 28.6% increase in equipment availability (percentage points), respectively. We conduct sensitivity analyses on our variable selection and use a random forest approach to validate that results are robust to changes in the model structure. We conclude that facility-level autonomy and especially budget control can improve primary healthcare facility readiness and service availability, even in resource-constrained contexts, Further, this can be achieved through good management practices that are reinforced through supportive supervision and routine performance monitoring to maximize the gains that result from incremental financing. This shows that these policies and practices can be critical contributors to efficiently achieving the goals of universal healthcare policies in the context of limited resources.

This perspective is focused on the evidence on human resources for health (HRH) solutions for immunization, as a part of a primary health care (PHC) approach.. In the wake of the COVID-19 pandemic and 50 years since the Expanded Program on Immunization (EPI) clocks 50 years since its inception. was initiated, evidence and experience demonstrate the significant HRH gaps in many countries and globally, and how countries are seeking innovative ways of closing them with limited resources. The aim of this perspective article is to highlight the growing gap between the needs and the realities related to health workforce for PHC, including immunization, and to call for increasing the visibility of HRH within global and national immunization agendas. This perspective highlights key guidelines and tools to improve HRH, such as integrating immunization and primary health care, addressing the mental health needs of the health workforce, addressing gender-related issues, rationalizing the roles and composition of PHC workforce teams, and meeting the surge requirements related to health emergencies.