Maleyeff Lara, Moodie Erica E M, Golchi Shirin
Department of Epidemiology, Biostatistics, and Occupational Health McGill University, Montréal, QC, Canada.
J Infect Dis. 2024 Oct 9. doi: 10.1093/infdis/jiae493.
Traditional Randomized Controlled Trials often fall short in addressing the specific needs of clinical practice due to their one-size-fits-all treatment approaches. Sequential Multiple Assignment Randomized Trials (SMARTs) offer a dynamic and adaptive approach, allowing for multiple randomizations based on patient responses and evolving conditions. SMARTs enable personalized treatment pathways, such as in the trial for antiretroviral therapy (ART) in South Africa, which adjusts treatment based on patient outcomes. Despite these advantages, the use of SMARTs in infectious diseases remains limited. Greater adoption of SMARTs could promote more personalized treatment approaches, improve flexibility in response to public health needs, and enhance the effectiveness of interventions. However, challenges such as recruitment and increased expertise needed for more complex analyses must be addressed. Additionally, combining SMARTs with other adaptive designs could further improve the relevance and outcomes of clinical research.
传统的随机对照试验往往因采用一刀切的治疗方法而无法满足临床实践的特定需求。序贯多重分配随机试验（SMARTs）提供了一种动态且适应性强的方法，允许根据患者反应和不断变化的病情进行多次随机分组。SMARTs能够实现个性化的治疗路径，比如在南非的抗逆转录病毒疗法（ART）试验中，该试验会根据患者的治疗结果调整治疗方案。尽管有这些优势，但SMARTs在传染病领域的应用仍然有限。更广泛地采用SMARTs可以促进更个性化的治疗方法，提高应对公共卫生需求的灵活性，并增强干预措施的有效性。然而，诸如招募患者以及进行更复杂分析所需的专业知识增加等挑战必须得到解决。此外，将SMARTs与其他适应性设计相结合可以进一步提高临床研究的相关性和成果。
