Interim Analyses. There are no plans to conduct an interim analysis and no criteria by which the study would be terminated early based upon statistical determination.
Interim Analyses. 1Timeframe and data population Eg., safety data at end of week 12 Business Need Eg., IDMC 1Timeframe can be either relative (at end of week 12) or a specific date (18Jun02) 6 CDS involvement in Investigator/Coordinator Meetings {insert level of involvement in meetings} 7 Study-specific Integrated Data Quality Plan and Data Validation Specification {insert doclink to electronic final Quality Framework if desired} {insert agreements surrounding the QF or the DVS if desired, or note these documents are agreed and their location}
Interim Analyses. An independent DSMC will be established to monitor the progress of the study, ensure that the safety of subjects enrolled in the study is not compromised, and determine if the study should be stopped for futility/efficacy or the study population should be enhanced with a higher percentage of patients with lower baseline LVEF to meet the initial event rate assumptions included in calculations of study sample size/power. The DSMC will not be otherwise involved in the conduct of the study. See Section 3.3, Study Committees and Section 12.2.5, Processing Primary Clinical Endpoint Safety Events for additional information on the DSMC.
Interim Analyses. An interim analysis will be performed when all subjects complete Visit 3A (20-40 days post 2nd eye implantation) in order to support the study publication plan of the test articles for near, intermediate and distance visual acuity, contrast sensitivity, defocus curves and adverse events. The interim analysis results will be distributed to a limited audience to limit potential bias in Visit 4A assessments. The clinical trial team with the exception of the Brand Lead will be masked to the interim analysis results.
Interim Analyses. As has been stated, there have been very few trials comparing long-term treatments for COPD to assess mortality. There is therefore a strong a priori desire to obtain a clear and unambiguous result from this trial if possible. However, it is recognised that there are ethical reasons for curtailing recruitment earlier than anticipated should either treatment be substantially more effective in increasing survival than the other, or where safety concerns arise with respect to either treatment. Furthermore, in the absence of a substantial body of data on the mortality rates in this population when treated with either of the study drugs, it is desirable to ensure that the study does not stop before sufficient information has been gathered to provide a definitive result. For these reasons, two interim analyses are planned in addition to the final analysis
6.2.2.1. Timing of planned interim analyses
Interim Analyses. Data Safety Monitoring Board One external independent DSMB will be formed for the study URO-901-2001. The detailed activities including meeting and analysis plan will be described and documented in the DSMB Charter and the DSMB SAP, respectively.
Interim Analyses. No formal interim analyses are planned for this study other than the safety assessments and scheduled external review.
Interim Analyses. No formal interim analyses will be performed in this study.
Interim Analyses. No formal interim safety analyses will be performed in this study.
Interim Analyses. No interim analysis is planned.
