Social Participation and Loneliness in Older Adults in a Rural Australian Context: Individual and Organizational Perspectives.

A rise in aging populations globally calls attention to factors that influence the well-being and health of older adults, including social participation. In Australia, rural older adults face cultural, social, and physical challenges that place them at risk for isolation. Thus, research surrounding social participation and healthy aging is increasingly relevant, especially in rural areas. This qualitative study in a remote town in Western Australia explores barriers and facilitators to older adults' social participation. To investigate multiple perspectives, 23 adults aged 50+ and 19 organizations from a rural town were interviewed. A stakeholder reference group was engaged to refine the research design and validate the findings. Feedback from early interviews was used to refine the data collection process, thus enhancing the validity of the findings. Thematic analysis showed that health and mobility issues, inadequate infrastructure, poor sustainability, and cultural tensions commonly impacted social participation. Themes of rural town culture, cultural power dynamics, and rural stoicism were identified as cultural aspects that inhibited participation. Based on results of this study and the supporting literature, recommendations for inclusive activities include supporting community-designed programs, utilizing culturally sensitive language and personnel, expanding services using existing community resources, and diversifying older adults' roles in existing groups.

An Evaluation of Novel Oncology Approvals with a PMR/C for Assessing Data in Racial and Ethnic Populations Underrepresented in Premarket Clinical Trials.

Clinical trials supporting oncology drug approvals frequently underrepresent diverse racial and ethnic populations. Recent policies have focused on ensuring premarket clinical trials are more inclusive and representative of racial and ethnic diversity in the general U.S. population or intended patient population; however, recent U.S. Food and Drug Administration (FDA) guidance on postmarketing approaches to collecting data in underrepresented populations demonstrates that, in certain circumstances, postmarketing requirements and/or commitments (PMR/Cs) may be issued to conduct more representative studies if there are remaining questions about safety or efficacy. This analysis demonstrates that prior to 2020, no drugs had PMR/Cs to further characterize use in a more representative population, and in the last 3 years, more than half of novel oncology approvals have had such a PMR/C (21/40, 53%). In addition, this analysis helps to identify characteristics, such as single-arm pivotal trial design, U.S. enrollment, and results of safety subgroup analyses based on race and ethnicity, that may contribute to decisions to issue a PMR/C to conduct a study that is more representative of the racial and ethnic diversity of the U.S. or intended patient population. These results can inform efforts to improve premarket clinical trials to ensure they are representative and able to characterize use in any patient who may need the drug.