Interim Analyses – DMC

Experts in Data Monitoring Committee Services

A unique combination of experience and expertise positions IDDI as a premier provider of comprehensive data monitoring committee services.

A Data Monitoring Committee (DMC) is a group of clinicians and biostatisticians appointed by the study Sponsor who provide independent assessment of the safety, scientific validity and integrity of a clinical trial while it is ongoing.

DMCs are strongly recommended by Regulatory Authorities in all trials that assess new interventions but also trials that can have safety issues and/or double blind/double mask treatment assignment. The main objective of these DMCs is to protect the patient.

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Data Monitoring Committees Comprehensive Services

DMC member contractingProgramming
Presentation of results at open and closed meetingData quality review
DMC organization including logisticsBlinded or unblinded analyses
Charter design and/or reviewTFLs for interim analyses
Safety and interim efficacy analysesReports
Design of templatesPresentation of results at open and closed meeting
Data Transfers
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DMCs as Independent Statistician in various therapeutic areas and indications

Deep Data Monitoring Committee (DMC) Experience

IDDI dedicates a portion of its biostatistics team to IDMC support: (experienced biostatisticians serving as independent statisticians, experts serving as DMC Members).

Our biostatisticians are true experts, delivering only what the committee members need in a succinct, complete and reproducible fashion.

Our years of experience supporting multiple DMCs have positioned us to develop a clear, precise report format that enables swift and thorough review of reports by DMC members.

Thanks to their extensive experience in DMCs, IDDI biostatisticians are highly knowledgeable about relevant statistical methods associated with interim analyses, including sequential designs, group-sequential designs, adaptive designs, conditional power and futility calculations, and sample-size adjustments.

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“My interaction with IDDI staff have been through e-mails and teleconferences. They were prompt in calling into meetings, and responding to e-mails.  They were quite flexible to AZ/IDMC requests. They were adept at pointing out risks that AZ had inadvertently overlooked, and would always offer solutions to mitigate the risks. The planning and actual meeting with the IDMC was hitch-free. IDDI staff was always very professional, and I would rate them 5 on a scale of 1 – 5.”
Ugochi A Emeribe, Principal Statistician, Astrazeneca R&D, Wilmington, DE, USA