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Conducting clinical trials is often complex and involves many individuals from a variety of services, each with a specific role in ensuring its successful implementation. Although an experienced clinical trialist may anticipate many of the challenges, others may be unexpected and detrimental to the successful completion of a study. We describe the use of simulation during preparation for initiation of a randomized clinical trial of a new preparation of antiseizure medication in neonates with seizures. The process of identification of stakeholders and roles, scenario development, and identification of challenges are described. Lessons learned included the potential benefits of simulation exercises, simulation challenges, and challenges associated with the study itself. We posit that going through the steps of a study, rather than merely reading them from a manual of procedures, will help identify potential barriers, complexities, and contingencies that are not readily apparent and may result in fewer protocol deviations and violations.

Abstract Background: A gap in the literature exists pertaining to a global research nurse/research midwife resources and communication skill set necessary to engage with participants of diverse populations and geographic regions in the community or home-based conduct of decentralized clinical trials. Aims: An embedded mixed methods study was conducted to examine research nurse/research midwife knowledge base, experiences, and communication skill sets pertaining to decentralized trials across global regions engaged in remote research: the USA, Republic of Ireland, United Kingdom, and Australia. Methods: An online survey was deployed across international research nurse/research midwife stakeholder groups, collecting demographics, decentralized trial experience, barriers and facilitators to optimal trial conduct, and the self-perceived communication competence (SPCC) and interpersonal communication competence (IPCC) instruments. Results: 86 research nurses and research midwives completed the survey across all countries: The SPCC and IPCC results indicated increased clinical research experience significantly correlated with increased SPCC score (p < 0.05). Qualitative content analysis revealed five themes: (1) Implications for Role, (2) Safety and Wellbeing, (3) Training and Education, (4) Implications for Participants, and (5) Barriers and Facilitators. Conclusions: Common trends and observations across the global sample can inform decentralized trial resource allocation and policy pertaining to the research nurse/research midwife workforce. This study demonstrates shared cultural norms of research nursing and midwifery across varied regional clinical trial ecosystems.

Communication is well-known to increase cooperation rates in social dilemma situations, but the exact mechanisms behind this remain largely unclear. This study examines the impact of communication on public good provisioning in an artefactual field experiment conducted with 216 villagers from small, rural communities in northern Namibia. In line with previous experimental findings, we observe a strong increase in cooperation when face-to-face communication is allowed before decision-making. We additionally introduce a condition in which participants cannot discuss the dilemma but talk to their group members about an unrelated topic prior to learning about the public good game. It turns out that this condition already leads to higher cooperation rates, albeit not as high as in the condition in which discussions about the social dilemma are possible. The setting in small communities also allows investigating the effects of pre-existing social relationships between group members and their interaction with communication. We find that both types of communication are primarily effective among socially more distant group members, which suggests that communication and social ties work as substitutes in increasing cooperation. Further analyses rule out better comprehension of the game and increased mutual expectations of one’s group members’ contributions as drivers for the communication effect. Finally, we discuss the role of personal and injunctive norms to keep commitments made during discussions.