An Independent Data Monitoring Committee comprises an independent group of experts who review the accumulating data of an ongoing trial and monitor patient safety and, where applicable, treatment efficacy. The committee ensures the interests of current and future patients are well served, and through its independence from the sponsor, ensures the continued scientific integrity of the trial is maintained.
IDMCs are particularly crucial in situations where there are severe risks to patient safety; they are most commonly seen in oncology trials where the endpoints are progression or death, and in studies with hospitalised populations as for COVID.
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What is needed?
For various reasons it may not be ethical to wait until the end of the trial before examining the unblinded data for the first time. The Data Monitoring Committee, therefore, reviews the data at specific predetermined time points to protect the best interests of the patients as the trial progresses. This may be to detect for a highly favorable or unfavorable result, or even assess futility with the view to terminating a study before its planned completion.
Robust statistical input is essential to underpin Data Monitoring Committees. This typically takes the form of an independent Statistical Analysis Centre that runs unblinded analyses and provides outputs for the clinicians to review, and an independent DMC Statistician that acts as a voting member of the Data Monitoring Committee and supports decision making from a statistical viewpoint.
At Veramed, we help sponsors manage their Data Monitoring Committees by providing essential services:
Statistical Analysis Centre
Independent DMC Statisticians
Critical Success Factors in Setting Up a Statistical Analysis Centre
For the IDMC to succeed, all these elements require intensive upfront planning and synchronisation. E.g. IDMC Charter, Data flow, System access and logistics.
We have a team of statisticians with experience working on IDMCs and within a range of therapeutic areas.
We have robust, GCP compliant systems and processes in place for data analysis and transfer to ensure the protection of the study blind and therefore the scientific validity of the trial.
Speed & Agility
We meticulously plan processes in advance to enable speed and agility in execution. We can tailor our approach to work on sponsor systems or using code that executes on different platforms.
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Veramed brings decades of experience in statistical analysis to IDMCs.
Matthew began his pharmaceutical career in SAS programming with Oxford Pharmaceutical Sciences (now Quanticate), where he honed his technical skills through various positions of ascending seniority. He subsequently worked in a variety of freelance and permanent programming positions across the industry for both CRO and large Pharma, and developed a deep working knowledge of several different outsourcing models.
Matthew holds a BSc in Economics from the University of Nottingham (1999) and an executive MBA from Cranfield University (2006).
Katherine’s particular interest is client relationship management: supporting and developing requirements to support the client needs, backed up with excellent project and budget management.
Katherine has an MSc in Applied Statistics (1994, Sheffield Hallam University) and a BSc in Mathematics (1986, Leeds University). As an active member of Statisticians in Pharmaceutical Industry (PSI), Katherine has held positions on their Board of Directors, including Chair (2011-2012).
His expertise includes clinical biostatistics; clinical study design, reporting and logistics; imaging informatics and medical image analysis, with applications in multiple therapeutic areas including neuroscience, cardiovascular, oncology and respiratory.
He also has detailed understanding of computing infrastructures, having been involved in software development, training and support.
Formally trained in pure mathematics (BSc, University of Durham, 1990) and statistics (MSc, University of Sheffield, 1991), Andrew gained a PhD from the University of Glasgow in 1994 for research into statistical methods for functional neuroimaging. He has co-authored numerous publications, book chapters and software packages.
Why choose us?
- We provide a team of expert statisticians who have technical and therapeutic area experience in IDMCs.
- We have GCP compliant systems in place that ensure the strict control of the study blind and to maintain confidentiality.
- As part of our set up process, we invest time and energy into the development of a strong IDMC charter, a comprehensive communication plan and timelines, and rigorous data flow mapping.
Get in touch to discuss how we can help.