“Having a family is the new normal”: Parenting in neoliberal academia during the COVID-19 pandemic

The outbreak of the COVID-19 pandemic has made explicit the burden of care shouldered by academic mothers, in addition to juggling their scholarly commitments. Although discussions are abundant on the impact of caring responsibilities on the careers of women academics, neoliberal academia continues to minimize such struggles. Despite the disruptions to family routines caused by the health crisis, academic institutions have expected academic mothers and fathers to continue undertaking their professional responsibilities at the same level as before, disregarding their parenting demands. This paper contributes to the research on parenthood in academia by looking at how, throughout the pandemic, academic parents have negotiated the tensions between parenthood and academic demands, and by investigating the strategies they use to confront neoliberal culture of academic performativity, even amid the health crisis. The paper engages with the “space invaders” concept used by Puwar (2004) to analyze the “hypervisibility” of academic mothers' and fathers' “bodies out of place” during the pandemic, and to investigate their “renegade acts” against the uncaring attitudes of their institutions. Evidence is drawn from a qualitative study conducted during December 2020 and January 2021 among scholars affiliated to Portuguese academic institutions: 17 in-depth interviews conducted with women, and two mixed-gender focus groups. Our results research reveal how the experiences of academic mothers and fathers were not uniform during the pandemic. In addition, it shows how, despite their commitment to their academic responsibilities, these parents have crafted various resistance strategies to confront the institutional pressure to continue maintain their working routines, and instead positioning themselves as “more than just academics.”     

Defining estimands for efficacy assessment in single arm phase 1b or phase 2 clinical trials in oncology early development

The addendum of the ICH E9 guideline on the statistical principles for clinical trials introduced the estimand framework. The framework is designed to strengthen the dialog between different stakeholders, to introduce greater clarity in the clinical trial objectives and to provide alignment between the estimand and statistical analysis. Estimand framework related publications thus far have mainly focused on randomized clinical trials. The intention of the Early Development Estimand Nexus (EDEN), a task force of the cross-industry Oncology Estimand Working Group ( www.oncoestimand.org ), is to apply it to single arms Phase 1b or Phase 2 trials designed to detect a treatment-related efficacy signal, typically measured by objective response rate. Key recommendations regarding the estimand attributes include that in a single arm early clinical trial, the treatment attribute should start when the first dose is received by the participant. Focusing on the estimation of an absolute effect, the population-level summary measure should reflect only the property used for the estimation. Another major component introduced in the ICH E9 addendum is the definition of intercurrent events and the associated possible ways to handle them. Different strategies reflect different clinical questions of interest that can be answered based on the journeys an individual subject can take during a trial. We provide detailed strategy recommendations for intercurrent events typically seen in early-stage oncology. We highlight where implicit assumptions should be made transparent as whenever follow-up is suspended, a while-on-treatment strategy is implied.