在初级保健中设计和实施大规模随机对照临床试验的民主化:个人观点。

IF 2.3 4区 医学 Q2 MEDICINE, GENERAL & INTERNAL European Journal of General Practice Pub Date : 2024-12-01 Epub Date: 2024-01-05 DOI:10.1080/13814788.2023.2293702
Christopher C Butler
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引用次数: 0

摘要

背景:在大流行病期间,迅速确定社区使用的有效治疗方法对于个人的福祉以及医疗保健系统和社会的可持续发展至关重要。此外,找出无效的治疗方法可减少研究浪费,使人们避免不必要的副作用,合理降低购买和储存药物的成本,并减少不适当的药物使用。然而,只有极少数针对 SARS-CoV-2 感染的治疗试验是在初级保健领域进行的:大多数试验开展得太晚,很难招募到人员,而且几乎没有产生可操作的结果。参与研究往往受到居住地或接受医疗服务地点的限制,而且试验参与者可能并不代表治疗对象:ALIC4E、PRINCIPLE 和正在进行的 PANORAMIC 试验已随机抽取了 40500 多名 COVID-19 患者。这篇个人观点描述了这些试验如何在以下方面进行创新:试验设计(采用新颖的适应性平台设计);试验实施(对传统的现场招募("病人来参加研究")进行补充,建立机制让病人、感染者足不出户就能参加试验("将研究带到人们身边"),并解决 "反向研究参与法 "问题,该法强调了那些对研究贡献最大并能从研究中获益的人所面临的不成比例的障碍,以及通过评估九种药物来改变证据基础,为全世界 COVID-19 的指导方针和护理决策提供支持,并为抗菌药物管理做出贡献。结论:PRINCIPLE 试验和 PANORAMIC 试验是创新和包容性的典范,体现了初级保健在应对全球紧迫健康挑战方面的领导潜力。
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Democratising the design and delivery of large-scale randomised, controlled clinical trials in primary care: A personal view.

Background: Rapid identification of effective treatments for use in the community during a pandemic is vital for the well-being of individuals and the sustainability of healthcare systems and society. Furthermore, identifying treatments that do not work reduces research wastage, spares people unnecessary side effects, rationalises the cost of purchasing and stockpiling medication, and reduces inappropriate medication use. Nevertheless, only a small minority of therapeutic trials for SARS-CoV-2 infections have been in primary care: most opened too late, struggled to recruit, and few produced actionable results. Participation in research is often limited by where one lives or receives health care, and trial participants may not represent those for whom the treatments are intended.

Innovative trials: The ALIC4E, PRINCIPLE and the ongoing PANORAMIC trial have randomised over 40,500 people with COVID-19. This personal view describes how these trials have innovated in: trial design (by using novel adaptive platform designs); trial delivery (by complementing traditional site-based recruitment ('the patient comes to the research') with mechanisms to enable sick, infectious people to participate without having to leave home ('taking research to the people'), and by addressing the 'inverse research participation law,' which highlights disproportionate barriers faced by those who have the most to contribute, and benefit from, research, and; in transforming the evidence base by evaluating nine medicines to support guidelines and care decisions world-wide for COVID-19 and contribute to antimicrobial stewardship.

Conclusion: The PRINCIPLE and PANORAMIC trials represent models of innovation and inclusivity, and exemplify the potential of primary care to lead the way in addressing pressing global health challenges.

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来源期刊
European Journal of General Practice
European Journal of General Practice PRIMARY HEALTH CARE-MEDICINE, GENERAL & INTERNAL
CiteScore
5.10
自引率
5.90%
发文量
31
审稿时长
>12 weeks
期刊介绍: The EJGP aims to: foster scientific research in primary care medicine (family medicine, general practice) in Europe stimulate education and debate, relevant for the development of primary care medicine in Europe. Scope The EJGP publishes original research papers, review articles and clinical case reports on all aspects of primary care medicine (family medicine, general practice), providing new knowledge on medical decision-making, healthcare delivery, medical education, and research methodology. Areas covered include primary care epidemiology, prevention, diagnosis, pharmacotherapy, non-drug interventions, multi- and comorbidity, palliative care, shared decision making, inter-professional collaboration, quality and safety, training and teaching, and quantitative and qualitative research methods.
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