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Characteristics of Clinical Trials Registered in ClinicalTrials.gov, 2007-2010
Context Recent reports highlight gaps between guidelines-based treatment recommendations and evidence from clinical trials that supports those recommendations. Strengthened reporting requirements for studies registered with ClinicalTrials.gov enable a comprehensive evaluation of the national trials portfolio.
Objective To examine fundamental characteristics of interventional clinical trials registered in the ClinicalTrials.gov database.
Methods A data set comprising 96 346 clinical studies from ClinicalTrials.gov was downloaded on September 27, 2010, and entered into a relational database to analyze aggregate data. Interventional trials were identified and analyses were focused on 3 clinical specialties—cardiovascular, mental health, and oncology—that together encompass the largest number of disability-adjusted life-years lost in the United States.
Main Outcome Measures Characteristics of registered clinical trials as reported data elements in the trial registry; how those characteristics have changed over time; differences in characteristics as a function of clinical specialty; and factors associated with use of randomization, blinding, and data monitoring committees (DMCs).
Results The number of registered interventional clinical trials increased from 28 881 (October 2004–September 2007) to 40 970 (October 2007–September 2010), and the number of missing data elements has generally declined. Most interventional trials registered between 2007 and 2010 were small, with 62% enrolling 100 or fewer participants. Many clinical trials were single-center (66%; 24 788/37 520) and funded by organizations other than industry or the National Institutes of Health (NIH) (47%; 17 592/37 520). Heterogeneity in the reported methods by clinical specialty; sponsor type; and the reported use of DMCs, randomization, and blinding was evident. For example, reported use of DMCs was less common in industry-sponsored vs NIH-sponsored trials (adjusted odds ratio [OR], 0.11; 95% CI, 0.09-0.14), earlier-phase vs phase 3 trials (adjusted OR, 0.83; 95% CI, 0.76-0.91), and mental health trials vs those in the other 2 specialties. In similar comparisons, randomization and blinding were less frequently reported in earlier-phase, oncology, and device trials.
Conclusion Clinical trials registered in ClinicalTrials.gov are dominated by small trials and contain significant heterogeneity in methodological approaches, including reported use of randomization, blinding, and DMCs
Moving Upstream: Policy strategies to address social, economic, and environmental conditions that shape health inequities
Policy Brie
COMMUNITY-DEFINED SOLUTIONS FOR LATINO MENTAL HEALTH CARE DISPARITIES: California Reducing Disparities Project, Latino Strategic Planning Workgroup Population Report
None reported
Type 2 Diabetes and Ethnic Disparities in Cognitive Impairment
Abstract available at publisher's website
Making Sense of the Global Health Crisis: Policy Narratives, Conflict, and Global Health Governance
Health has become a policy issue of global concern. Worried that the unstructured, polycentric, and pluralist nature of global health governance is undermining the ability to serve emergent global public health interests, some commentators are calling for a more systematic institutional response to the “global health crisis.” Yet global health is a complex and uncertain policy issue. This article uses narrative analysis to explore how actors deal with these complexities and how uncertainties affect global health governance. By comparing three narratives in terms of their basic assumptions, the way they define problems as well as the solutions they propose, the analysis shows how the unstructured pluralism of global health policy making creates a wide scope of policy conflict over the global health crisis. This wide scope of conflict enables effective policy-oriented learning about global health issues. The article also shows how exclusionary patterns of cooperation and competition are emerging in health policy making at the global level. These patterns threaten effective learning by risking both polarization of the policy debate and unanticipated consequences of health policy. Avoiding these pitfalls, the analysis suggests, means creating global health governance regimes that promote openness and responsiveness in deliberation about the global health crisis
Virginia Health Equity Report 2012
The 2012 Virginia Health Equity Report draws attention to health inequities among Virginians of varying socioeconomic, racial/ethnic, and urban/rural backgrounds. It recommends various inter-sectoral strategies and collaboration, for promoting health equity in Virginia. It provides a foundation on which partners and stakeholders can develop new plans/strategies and also receive/provide education on the Social Determinants of Health (SDOH), with the goal of shaping policy and decision-making that promotes health equity in Virginia
Literature-Based Appraisal of Racial/Ethnic Cardiovascular Health Care Disparities
Abstract available at publisher's website
Do Latino and non-Latino grocery stores differ in the availability and affordability of healthy food items in a low-income, metropolitan region?
Abstract available at publisher's website