Transparency of Regulatory Data across the European Medicines Agency, Health Canada, and US Food and Drug Administration.

Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.

Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis.

OBJECTIVES: To characterize postmarketing requirements for new drugs and biologics approved by the US Food and Drug Administration (FDA), and to examine rates and timeliness of registration, results reporting, and publication of required prospective cohort studies, registries, and clinical trials. DESIGN: Cross sectional analysis. SETTING: Postmarketing requirements for all new drugs and biologics approved by the FDA between 1 January 2009 and 31 December 2012, with follow-up up to 15 November 2017. MAIN OUTCOME MEASURES: Postmarketing requirements and their characteristics known at the time of FDA approval, including FDA authority, study design, and study characteristics. Rates and timeliness of registration and results reporting on ClinicalTrials.gov and publication in peer reviewed journals of required prospective cohort studies, registries, and clinical trials. RESULTS: Between 2009 and 12, the FDA approved 97 new drugs and biologics for 106 indications with at least one postmarketing requirement at the time of first approval, for a total of 437 postmarketing requirements. Postmarket study descriptions were short (median word count 44 (interquartile range 29-71)) and often lacked information to determine an up to date progress (131 (30%)). 220 (50.3%) postmarketing requirements were for new animal or other studies (including pharmacokinetic studies); 134 (30.7%) were for prospective cohort studies, registries, and clinical trials; and 83 (19.0%) were for secondary analyses or follow-up studies. Of 110 clinical trials, 38 (34.5%), 44 (40.0%), 62 (56.4%), 66 (60.0%), and 98 (89.1%) did not report enough information to establish use of randomization, comparator type, allocation, outcome, and number of patients to be enrolled, respectively. Of 134 required prospective cohort studies, registries, and clinical trials, 102 (76.1%) were registered on ClinicalTrials.gov; of 50 registered and completed studies, 36 (72.0%) had reported results on ClinicalTrials.gov. Among 65 completed studies, 47 (72.3%) had either reported results or were published a median of 47 months (interquartile range 32-67) after FDA approval. 32 (68.1%) of these 47 studies did not report results publicly by the time of their original FDA report submission deadline. CONCLUSIONS: Postmarketing requirements for new drugs and biologics were often briefly described and did not contain enough information to characterize study designs. Approximately three quarters of postmarketing requirements for prospective cohort studies, registries, and clinical trials were registered on ClinicalTrials.gov, and nearly three quarters of completed studies reported results or were published, suggesting that at least a quarter of these required studies are not being publicly disseminated.

Income inequality and child maltreatment in the United States.

OBJECTIVE: To examine the relation between county-level income inequality and rates of child maltreatment. METHODS: Data on substantiated reports of child abuse and neglect from 2005 to 2009 were obtained from the National Child Abuse and Neglect Data System. County-level data on income inequality and children in poverty were obtained from the American Community Survey. Data for additional control variables were obtained from the American Community Survey and the Health Resources and Services Administration Area Resource File. The Gini coefficient was used as the measure of income inequality. Generalized additive models were estimated to explore linear and nonlinear relations among income inequality, poverty, and child maltreatment. In all models, state was included as a fixed effect to control for state-level differences in victim rates. RESULTS: Considerable variation in income inequality and child maltreatment rates was found across the 3142 US counties. Income inequality, as well as child poverty rate, was positively and significantly correlated with child maltreatment rates at the county level. Controlling for child poverty, demographic and economic control variables, and state-level variation in maltreatment rates, there was a significant linear effect of inequality on child maltreatment rates (P < .0001). This effect was stronger for counties with moderate to high levels of child poverty. CONCLUSIONS: Higher income inequality across US counties was significantly associated with higher county-level rates of child maltreatment. The findings contribute to the growing literature linking greater income inequality to a range of poor health and well-being outcomes in infants and children.

Utilizing K-12 school and higher education programs to incorporate homeland security topics for public education.

The broad based mission statements of public institutions whose charters are to educate the public is analyzed so that common threads pertinent to homeland security action items can be correlated with the public education scope. The intent of the coordination is to ensure that the prevention component in addition to the preparedness issues of homeland security is incorporated into the educational system with short and long term goals.

Using resources of public health centers for education and professional societies to incorporate homeland security topics into public teacher continuing education.

The Department of Education, the Association of Schools of Public Health, and national professional societies dedicated to teaching and dissemination of information for health and education in the public sector can form a clearinghouse on information and manpower on Homeland Security by affiliation with Centers for Public Health Preparedness (CPHP). The state licensed or regional societies can contribute further information and guidelines. In the HPS the Science Teacher Workshop (STW) and Public Education (PEC) Committees can assist a CPHP on radiation issues.