(株)ジーエヌアイグループ【2160】の掲示板 2020/09/04〜2020/09/05

>>1216

ガイドラインはこちらですかね。
ttps://www.fda.gov/media/119044/download

ガイドラインの中にも以下のように書かれています。
今行われているNASH関連の治験の多くは、BiopsyでNASH（及び肝線維化）と確認されていることをinclusionの条件としていますが、患者への負担なども考えてNASH及び肝線維化の程度を正確に判定する非侵襲なbiomakersの研究もされてるのは確かです。

"At this time, reliable diagnosis and staging of NASH can only be made by histopathological examination of a liver biopsy specimen. Liver biopsy, however, is an invasive procedure that is associated with occasional morbidity and, in rare circumstances, mortality. The use of liver biopsies in clinical trials poses significant logistical challenges (e.g., cost, availability of pathologists with specific expertise in NASH); in addition, some patients are reluctant or unwilling to undergo biopsy. Therefore, noninvasive biomarkers are needed (including imaging biomarkers) to supplant liver biopsy and provide a comparable or superior ability to accurately diagnose and assess various grades of NASH and stages of liver fibrosis. Identification and validation of such biomarkers could significantly accelerate drug development in NAFLD. FDA encourages sponsors to consider biomarker development. "