Overview
Short Course Registration: 7:30-5:30PM
Over the past five decades as the role of the randomized clinical trial (RCT) has appropriately evolved to become the gold standard for evaluation of new pharmaceuticals, devices, procedures, and behavioral interventions, so has the role of the IDMC, also referred to as the Data and Safety Monitoring Board (DSMB), recommended by the Greenberg Report in 1967. On the basis of the review of the totality of the evidence, including the emerging unblinded data, the IDMC may recommend changes in the RCT or perhaps early termination if the data show evidence of harm or overwhelming evidence of benefit.The number of clinical trials that are overseen by independent Data Monitoring Committees (DMC)/Data and Safety Monitoring Boards is ever-increasing. Accompanying the growth of the use of IDMCs in the past 35 years has been the increase use of an independent SDAC which provides interim reports for the IDMC. Despite this enormous growth, the number of clinical and statistical scientists trained to be members of IDMCs and statistical groups with expertise and experience in providing SDAC-type support to IDMCs has lagged behind. The Clinical Trial Transformation Initiative (CTTI) surveyed the state of activity and training by contacting current DMC members, RCT sponsors, SDAC groups, and regulatory agencies regarding the level of participation in IDMCs and SDACs. This revealed that almost none had had training in DMC practices prior to their first time on a DMC, and most of those felt that such training would have been beneficial. Additionally, while many statistical centers and CROs have substantial experience in developing DMC reports and presenting them at DMC meetings, many others are new to these processes.
This course will cover the basics of DMC operations, including the following topics:
- Typical responsibilities of DMCs
- DMC composition
- Structure of DMC meetings
- Responsibilities of the statistical center reporting to the DMC
- Development and content of optimal reports
- Statistical aspects of data monitoring
- Best operational practices
- Regulations and policies regarding operation of DMCs
- Emerging and controversial issues in data monitoring
Case studies to illustrate challenges that DMCs have faced will be presented. Presenters are all experienced clinical trialists who have served on many DMCs and have developed and presented DMC reports.
Have an account?