BRIEF—US FDA provides draft guidance on data monitoring

The US Food and Drug Administration has provided a  draft guidance document, consisting of recommendations to help drugmakers decide on best practice in respect of data monitoring.

Aimed at sponsors of clinical trials, the document helps determine what form of data monitoring is most appropriate for a clinical trial.

It also lays out information on what procedures and practices should be considered to guide the operation of data and safety monitoring committees (DSMC), and related trial monitoring groups.

The guidance revises and will eventually supercede an earlier document, which was first issued in March 2006.

Relevant parties are invited to  comment on the draft guidance.