RESUMEN
Background: The COVID-19 pandemic resulted in the implementation of social distancing measures, travel restrictions, and infection control measures that introduced a myriad of disruptions in the conduct of clinical research worldwide. As a result, many aspects of clinical research were variably impacted. Aim: To explore the impact of the first 18 months of the COVID-19 pandemic on clinical research across accredited nursing, pharmacy, and medicine program providers in Australian and New Zealand universities. Methods: Representatives from all program providers across Australian and New Zealand universities, with publicly available contact information, were invited to participate in this qualitative study, whereby semi-structured interviews were completed with participants who held senior research or leadership positions within their institution. Interviews were transcribed verbatim and inductively analysed using thematic content analysis. Findings: Interviews were conducted with 16 participants between August and October 2021. Two major themes were identified (Immediate Research Impact and Broader Research Impact) with six subthemes: Prioritisation, Continuation, and Dissemination of Research; Modifications to Research; Funding and Changes to Research Focus; Collaboration; Research Workforce; Context-specific Impacts. Discussion: The impact on clinical research in Australian and New Zealand universities included changes to data collection methods, a perceived decreased quality of research, changes to collaboration, neglect of basic disease research, and loss of the research workforce. Conclusion: This study highlights the impact of the COVID-19 pandemic on clinical research within the Australian and New Zealand university context. Implications of these impacts should be considered to ensure long-term sustainability of research and preparedness for future disruptions.
RESUMEN
BACKGROUND: In response to the COVID-19 pandemic, member countries of the Organisation for Economic Co-operation and Development (OECD) rapidly published guidance regarding the conduct of clinical research. A systematic review was conducted to explore the recommendations issued in relation to the commencement, continuation and termination of clinical research during the early phases of the pandemic. METHODS: Searches consisting of the terms "COVID-19", "clinical research", and "guidance", were conducted in PubMed, Embase, MEDLINE, Trip, Guidelines International Network, and Google in April-May 2021 (up to 4 May 2021). Data were extracted from guidance published from OECD member countries and mapped to inductively-developed categories. RESULTS: 9419 references were systematically screened, resulting in the inclusion of 46 publications from 27 OECD countries. Thirty-three sources made recommendations regarding monitoring, risk-benefit assessments and information technology. There was limited specific recommendations made in relation to personal protective equipment (PPE) in the included guidance. Findings demonstrate that guidance differed by publication date demonstrating the rapidly evolving environment within which research was conducted. Importantly, many organisations opted to endorse existing guidance published by the United States' Food and Drug Administration and the European Medicines Agency rather than develop their own recommendations. CONCLUSIONS: Given the rapidly evolving nature of the pandemic, particularly in the early stages, findings demonstrate the global response in relation to clinical research conduct, thereby providing important insights for future public health emergencies.
