On September 15, 2008, the independent data and safety monitoring committee recommended the discontinuation of study supplements because the alternative hypothesis of no evidence of benefit from either study agent was convincingly demonstrated and there was no possibility of a benefit to the planned degree with additional follow-up.
In addition, a data and safety monitoring committee is appointed to monitor most phase Ill trials and some phase II trials to safeguard the well-being of study subjects and ensure the scientific integrity of the research.
A pre-planned interim analysis of the study data by an independent Data and Safety Monitoring Committee (DSMC) demonstrated a statistically significant improvement in time to treatment failure (TTF) for patients receiving Rituxan and chemotherapy compared to chemotherapy alone.
BUSINESS WIRE)--March 6, 2003 IRIDEX Corporation (Nasdaq:IRIX) announced that the Executive Committee for the TTT4CNV Clinical Trial accepted the recommendations of the independent Data and Safety Monitoring Committee (DSMC) for the TTT4CNV Clinical Trial that adequate enrollment has now been attained, and an orderly process of concluding enrollment activities should commence with an end date to those activities to be set in mid-April, 2003.
An independent assessment of the interim results was performed by a Data and Safety Monitoring Committee (DSMC), comprised of third-party external reviewers.
The Data and Safety Monitoring Committee (DSMC) for the PTAMD Trial recently convened to review the data of patients enrolled in the PTAMD study, and has determined that enrollment and follow-up of patients in the bilateral study arm (BSD patients with "dry" AMD in both eyes) is to continue.
The just completed 6 and 12-month follow-up evaluations were undertaken at the recommendation of an Independent Data and Safety Monitoring Committee, following collaborative discussions with the FDA.
