Use of Data Monitoring Committees in Clinical Trials,Guidance for Industry(draft guidance)——interpret the development and practice of Data Monitoring Committee from the updated FDA guidelines
ZHENG Yu
DANG Hai-xia
LIU Jun
WANG Zhong
YU Ya-nan
Abstract：Use of Data Monitoring Committees in Clinical Trials,Guidance for Industry(draft guidance)is an updated draft of the U.S.FDA guidance issued in February 2024 to address developments in Data Monitoring Committees(DMC)since the issuance of the 2006 guidance.The Draft Update,issued by the FDA in February 2024,intends to accommodate developments in DMC since the 2006 the guidance was issued.The draft update focuses on the organizational structure and operational processes of DMC,and improves the 2006 guidance by focusing on six core elements:expansion of the scope of application,integration of innovative clinical trial designs,refinement of the bylaws,globalization,upgrading of the scope of monitoring,and expansion of the functions of the DMC.Based on the practice and development history of DMC in the past 20 years,this paper provides systematic interpretation and analysis of the draft with the six updated points as the core,with a view to help many clinical researchers to better understand and master the draft,promoting the standardized application of DMC in clinical trials,and enabling them to more effectively fulfill their supervisory roles.
Keywords：Data Monitoring Committeeclinical trialsguidance interpretationFDA draft guidanceadaptive clinical trials
Publication Date：2026-03-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 470-475 )