A Critical Review of Methods for Real-World Applications to Generalize or Transport Clinical Trial Findings to Target Populations of Interest

Autor:	Ling, Albee Y., Montez-Rath, Maria E., Carita, Paulo, Chandross, Karen, Lucats, Laurence, Meng, Zhaoling, Sebastien, Bernard, Kapphahn, Kris, Desai, Manisha
Rok vydání:	2022
Předmět:	Statistics - Applications
Druh dokumentu:	Working Paper
Popis:	Generalizability and transportability methods have been proposed to address the external validity bias of randomized clinical trials that results from differences in the distribution of treatment effect modifiers between trial and target populations. However, such studies present many challenges. We review and summarize state-of-the-art methodological considerations. We additionally provide investigators with a step-by-step guide to address these challenges, illustrated through a published case study. When conducted with rigor, such studies may play an integral role in regulatory decisions by providing key real-world evidence.
Databáze:	arXiv
Externí odkaz:	http://arxiv.org/abs/2202.00820 Zobrazit plný text záznamu View this record from Arxiv