Ｄｅｌｔａ－Ｆｌｙ Ｐｈａｒｍａ(株)【4598】の掲示板 2024/04/27〜2024/05/07

>>1080

ご参考

ダイレクトに書いてるわけじゃないけど・・・。
FDAとDMCが直接コミュニケーションするのは非常に稀だと読めるよ。
最も重要であろう安全性の問題に関してすら、スポンサーに依頼してDMCとコミュニケーションを取るって書いてるしね。

https://www.jdsupra.com/legalnews/fda-issues-draft-guidance-on-use-of-1823832/

FDA provides extensive considerations regarding DMC consideration of the impact of new external information on an ongoing clinical trial, such as unexpected adverse safety results in another trial of the investigational product. The draft guidance says, “When FDA has critical safety information regarding another trial of the investigational product or a trial of a related product from the same sponsor that is relevant and important for a DMC to consider,” then FDA may ask the sponsor to confirm that the DMC is aware of the data and/or may request that the sponsor arrange for FDA to communicate with the DMC directly.