ARE THERE PLANS FOR INTERIM ANALYSES?
ANSWER As per Rita-3 protocol (October 1997 pages 35/36) no interim analysis is planned. However, the Data Safety and Monitoring Committee (DSMC) meet approximately every 6 months to review the data of all patients who have completed their 4 month follow up. Their main aim is to protect the interests of the patients included in the trial in all respects. In previous meetings, they have fed back certain recommendations such as the exclusion log. The DSMC has recorded that the data from the centres has been of the highest quality. They recommend that the Rita-3 trial continue to recruit. The next DSMC is planned for Jan. 2001.
