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ABSTRACT:The paper describes empirical investigations of how participants in a MOOC learn, and the implications for MOOC design. A learner capabi lity to generate higher order learning in MOOCs -called crowd-sourced learning (C-SL) capability -was defined from learning science literature. The capability comprised a complex yet interrelated array of attitudes, beliefs, and understandings about learning that participants bring to a MOOC and which shape their behaviour and explain why individuals differ in their ability to generate higher order learning. The capability was formulated as a developmental progression describing behaviours associated wi th five levels, from novice to expert, charting the degree to which learners regulate their own learning, effectively exploit the scale and diversity of MOOCs, and harness opportunities for distributed teaching. Item response theory was applied to log stream data in two MOOCs to construct empirically validated measures of this capability, enabling each MOOC learner to be assessed for learning capability on a scale from novice to expert. The majority of participants di d not behave in ways conducive to the generation of higher order learning, but the C-SL progression suggested principles to guide MOOC design to make them more efficacious, which, when empirically investigated, were found to be efficacious.

A global crisis the magnitude of coronavirus disease 2019 (COVID-19) can transform drug development and review. It has exposed vulnerabilities and inadequacies in the global healthcare ecosystem as well as spurred innovation, rapid adaption of novel solutions, and unprecedented collaboration among global regulatory agencies, sponsors, and researchers. For the continued and future benefit of patients, it is imperative that all stakeholders leverage the solutions, learnings, and momentum catalyzed by this crisis to advance regulatory science in the drug development process.

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