Perspectives on Enquiry & Evidence
Cytel's blog featuring the latest industry insights.
April 15, 2024
In the context of clinical trials, reducing the workload of the clinical team without compromising data quality is...
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April 2, 2024
The FDA’s New Draft Guidance on DMCs: What to Know
Data monitoring committees (DMCs) review ongoing clinical trial data to make recommendations regarding trial conduct...
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January 19, 2024
Accelerated DMC Safety Reports for Biotech’s Central Nervous System Studies: A Case Study
Independent data monitoring committees help to ensure patient safety and uphold trial integrity. In Central Nervous...
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December 4, 2023
Preserving Trial Integrity After Receiving an Unanticipated IDMC Recommendation
Independent data monitoring committees review unblinded clinical trial data and issue recommendations to designated...
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November 10, 2023
Conduct of IDMCs for Cell and Gene Therapy Trials
Independent data monitoring committees review unblinded clinical trial data and issue recommendations to designated...
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September 25, 2023
Reducing Independent Data Monitoring Committee Timelines: A Focus on Formal Interim Analyses
As the pressure to reduce timelines rises across the industry, independent data monitoring committees (IDMCs) — which...
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September 13, 2023
Setting Expectations for Formal Interim Analyses with Independent Data Monitoring Committees
Independent data monitoring committees (IDMCs) review ongoing clinical trial data to make recommendations regarding...
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October 14, 2022
Career Perspectives: A Conversation with Nicolas Rouillé
In this edition of the Career Perspectives series, I interview Nicolas Rouillé, Senior Director, Statistical...
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November 19, 2020
10 Key Qualifications for Independent Statisticians Reporting to the DMC
Data Monitoring Committees (DMCs) are groups of independent experts who periodically receive (by-arm) reports created...
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November 27, 2019
Interview with David Kerr: Data Monitoring Committees (DMCs) – Behind Closed Doors
At the 2019 Challenges in Rare Diseases Clinical Trials Symposium and East training, Cytel partnered with Alexion to...
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