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Purpose Children have historically been excluded from first-in-human studies of promising new cancer drugs and later phase adult clinical trials. Delays in evaluation may result in off-label use without dosing information as the only access to new drugs. A multistakeholder workshop was convened in May 2016 by ASCO and Friends of Cancer Research to identify opportunities for when it would be scientifically appropriate to expand trial eligibility to include children younger than age 18 years in first-in-human and other adult cancer clinical trials. Methods This group convened experts from academia, government, and industry to review barriers to enrolling children and adolescents in oncology clinical trials. We evaluated the historical context, published literature, regulatory considerations, and myriad risks and benefits associated with lowering the age of enrollment on oncology clinical trials. Results We conclude that many of the historical concerns about including children early in oncology clinical trials do not apply in the current scientific and clinical environment of pediatric oncology and drug development; we provide specific recommendations for how the inclusion of children in early-phase investigational cancer drug trials might be accomplished. Automatic inclusion of pediatric patients is appropriate in early-phase trials that assess dose, safety, and pharmacokinetics in a variety of tumor types and later phase trials that assess efficacy in a specific disease that spans adult and pediatric populations. Conclusion Including children in appropriately designed adult clinical oncology trials is feasible and can be done in a way that enhances their access to these agents without compromising safety or development strategies.

Background: To investigate the effects of age and sex on the relationship between socioeconomic status (SES) and the prevalence and control status of diabetes mellitus (DM) in Korean adults., Methods: Data came from 16,175 adults (6,951 men and 9,227 women) over the age of 30 who participated in the 2008-2010 Korea National Health and Nutrition Examination Survey. SES was measured by household income or education level. The adjusted odds ratios (ORs) and corresponding 95% confidence intervals (95% CI) for the prevalence or control status of diabetes were calculated using multiple logistic regression analyses across household income quartiles and education levels., Results: The household income-DM and education level-DM relationships were significant in younger age groups for both men and women. The adjusted ORs and 95% CI for diabetes were 1.51 (0.97, 2.34) and 2.28 (1.29, 4.02) for the lowest vs. highest quartiles of household income and education level, respectively, in women younger than 65 years of age (both P for linear trend < 0.05 with Bonferroni adjustment). The adjusted OR and 95% CI for diabetes was 2.28 (1.53, 3.39) for the lowest vs. highest quartile of household income in men younger than 65 (P for linear trend < 0.05 with Bonferroni adjustment). However, in men and women older than 65, no associations were found between SES and the prevalence of DM. No significant association between SES and the status of glycemic control was detected., Conclusions: We found age- and sex-specific differences in the relationship of household income and education with the prevalence of DM in Korea. DM preventive care is needed for groups with a low SES, particularly in young or middle-aged populations.

Objective: Accurate perception of asthma episodes increases the likelihood that they will be managed effectively. The purpose of the study was to examine the effect of feedback in a signal detection task on perception of increased airflow obstruction in children with persistent asthma., Methods: The effect of feedback training on the perception of resistive loads was evaluated in 155 children with persistent asthma between 8 and 15 years of age. Each child participated in four experimental sessions that occurred approximately once every 2 weeks, an initial session followed by three training sessions. During the initial session, the threshold resistance to breathing was determined for each child. Subsequently, each child was randomly assigned to one of two resistive load training conditions in a signal detection paradigm: training with immediate performance feedback or training with no performance feedback., Results: The threshold resistance to breathing, determined in the initial session, was equivalent between groups. Children in the feedback condition discriminated more accurately between both the presence and the absence of increases in the resistance to breathing (206 [48] versus 180 [39] correct responses, p < .001), and differences over time between groups increased reliably as a function of training (165 [40] versus 145 [32] correct responses, p < .001). Response times and confidence ratings were equivalent between groups, and no differences in breathing patterns were observed between conditions., Conclusions: Feedback training results in improved perception of respiratory sensations in children with asthma, a finding with implications for strategies of asthma self-management.