Leading beyond regulatory approval: Opportunities for statisticians to optimize evidence generation and impact clinical practice

The role and value of statistical contributions in drug development up to the point of health authority approval are well understood. But health authority approval is only a true ‘win’ if the evidence enables access and adoption into clinical practice. In today's complex and evolving healthcare environment, there is additional strategic evidence generation, communication, and decision support that can benefit from statistical contributions. In this article, we describe the history of medical affairs in the context of drug development, the factors driving post-approval evidence generation needs, and the opportunities for statisticians to optimize evidence generation for stakeholders beyond health authorities in order to ensure that new medicines reach appropriate patients.     

Connection,connectivity and choice: Learning during COVID-19 restrictions across mainstream schools and Flexible Learning Programmes in Australia

The COVID-19 pandemic and associated school closures may have constrained educational participation particularly for students in disadvantaged circumstances. We explore how 30 disadvantaged students in secondary school (14 mainstream/16 Flexible Learning Programme) from Queensland, New South Wales and Tasmania experienced home learning during the first wave of COVID-19, teasing out nuances across two educational models. Drawing on semi-structured interviews with these students, our analysis revealed three interconnected themes inflecting their learning: connection, connectivity and choice. Connection captures the desire for belonging and practices that facilitated meeting this desire during system-wide disruptions to school routines and face-to-face learning. Connectivity captures the impact of digitally facilitated learning at home on students' ability to engage with curriculum content and with their learning community. Choice captures the availability of viable options to overcome barriers students encountered in their learning and possibilities to flexibly accommodate student preferences and learning needs. Students from Flexible Learning Programmes appeared generally better supported to exercise agency within the scope of their lived experience of home-based learning. Findings indicate a need for strengthening student-centred policy and practices aimed at leveraging the affordances of information technology, balancing self-directed and structured learning and providing holistic support to enable meaningful student choice.     

Progress of the social service professions in South Africa's developmental social welfare system: Social work,and child and youth care work

This paper examines the progress of the social service professions delivering developmental social welfare in South Africa, a subject we have followed closely over the last 20 years. Being policy-driven, developmental social welfare stemmed from expert social analyses that resulted in technically oriented solutions, including the broadening of social service professions. Twenty years on, it is hard to see developmental social welfare, as envisaged in government policy, in action, since the practice reality does not differ drastically from the prior apartheid system with the government's heavy reliance on social security as a poverty-alleviation measure. The expanded social security budget has led to underfunded services and a crisis for social service professionals. This paper focuses on the regulated professions of social workers, and child and youth care workers. Our examination of critical issues for these occupational groups revealed that South Africa still has a long way to go in building a strong social service workforce.