Q&A on Data Monitoring Committees: EMA Drafts Consultation
Posted 06 August 2018 | By
The European Medicines Agency (EMA) last week opened a consultation on a new question and answer document on data monitoring committees.
The seven questions and answers deal with whether DMC recommendations are binding for a sponsor, whether a DMC can stop a study or change study design aspects (e.g. increase sample size, drop treatment arms), and communications between competent regulatory authorities and a DMC.
The document also questions if investigators should be informed about the outcomes of DMC meetings, when a DMC might be needed in early development phases and whether DMC members have to be external to a sponsor in early development.
The consultation ends on 31 July 2019.
Questions and answers on Data Monitoring Committees issues: Draft