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Activity Number:
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337
- Interim Monitoring and Analyses: Two-Stage, Multi-Stage, and Group Sequential Designs
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Type:
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Contributed
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Date/Time:
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Tuesday, August 1, 2017 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #324250
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View Presentation
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Title:
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The Three Keys to Having Effective Interim Review Data Monitoring Committee Meetings for Clinical Trials
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Author(s):
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Navneet Hakhu*
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Companies:
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Axio Research
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Keywords:
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Data Monitoring Committee ;
Clinical Trial ;
Interim Monitoring ;
Interim Review ;
Program-wide DMCs
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Abstract:
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A Data Monitoring Committee (DMC) for a clinical trial is an independent group of experts charged with protecting the interests of participating human volunteers while the trial is ongoing through interim reviews of safety and efficacy data to assess risk-benefit and make recommendations to the sponsor. After the DMC Organizational meeting has taken place the focus shifts to interim DMC review meetings. The three keys to having effective interim review DMC meetings for a single clinical trial are: (1) Materials--providing necessary documents and reports to the DMC; (2) Agenda--maximizing time during open and closed sessions to facilitate the DMC's review; and (3) Actions/Recommendations--identifying and documenting the action items and recommendations from the DMC to preserve the integrity of the trial. More recently there has been a shift toward program-wide DMCs in which a single DMC is tasked with monitoring multiple ongoing related trials at each interim review meeting. The three keys of materials, agenda, and actions/recommendations not only apply in this setting, but are more important in order to protect patients' interests and preserve the integrity of the trials.
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Authors who are presenting talks have a * after their name.
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