Centre for Epidemic Interventions Research, Norwegian Institute of Public Health, Oslo, Norway.
Centre for Evaluation of Public Health Measures, Norwegian Institute of Public Health, Oslo, Norway.
Trials. 2024 Oct 12;25(1):673. doi: 10.1186/s13063-024-08547-2.
Few randomized trials of public health and social measures were carried out during the COVID-19 pandemic. We report on the major barriers we faced when we tried to run such trials.
We reviewed all randomized trials proposed and initiated by the Centre for Epidemic Interventions Research in Norway during the COVID-19 pandemic.
Of the 18 proposed trials, 11 trials were not implemented. One of the key legal and ethical barriers to conducting the trials was the Norwegian Health Research Act, which demands informed consent from all participants who are exposed to an intervention. A lack of sufficient political support was also a challenge, as was unpredictability, due to shifting disease incidence and changing recommendations from the authorities.
Strengthening the evidence base for public health and social measures in pandemics will require political and public understanding and support and a legal framework that allows for the conduct of such trials.
在 COVID-19 大流行期间,很少有针对公共卫生和社会措施的随机试验。我们报告了在尝试进行此类试验时所面临的主要障碍。
我们审查了挪威传染病干预研究中心在 COVID-19 大流行期间提出和启动的所有随机试验。
在提出的 18 项试验中,有 11 项未实施。开展这些试验的一个主要法律和伦理障碍是挪威《健康研究法》,该法要求所有接触干预措施的参与者都要获得知情同意。缺乏足够的政治支持也是一个挑战,因为疾病发病率的不可预测性以及当局建议的不断变化也是一个挑战。
加强大流行期间公共卫生和社会措施的证据基础需要得到政治和公众的理解和支持,以及一个允许进行此类试验的法律框架。