What is a Data Monitoring Committee
A Data Monitoring Committee (DMC) comprises a multidisciplinary group of experts who periodically assess the accumulating safety and, where applicable, efficacy data of an ongoing clinical trial. The DMC protects the safety of participants and the scientific integrity of the study, advising the sponsor on study modification, continuation or termination. To avoid bias the DMC is external to the trial and independent of the sponsor.
Not all trials need a DMC, but where they do the DMC allows the sponsor and investigators to fulfil their responsibilities in overseeing the conduct of the trial whilst protecting the integrity of the trial and maintaining the blind.
Why use a Data Monitoring Committee
It may not be ethical to wait until the end of the trial before assessing the efficacy and safety of the treatments under study, such that interim assessments are required to protect the safety of ongoing and future trial participants. Another example is where a study may have preplanned interim analyses to support decisions on early stopping (either for futility or positive efficacy) or design adaptation (for example dropping a treatment in an umbrella design), requiring assessment of unblinded results whilst the study overall is blinded. To avoid the potential for bias or undue influence on subsequent trial conduct, an independent Data Monitoring Committee is used for such interim monitoring of unblinded/aggregate safety and efficacy results.
A DMC requires administrative and logistical support to set up, timely access to relevant (usually unblinded) analyses of accumulating study data during the study, and statistical support. These should also be independent of the sponsor, and are services we can provide.
Why choose Veramed
Our experience and expertise, combined with our processes, planning and technologies mean we can be trusted to seamlessly and independently service a DMC on your behalf, delivering with quality and integrity – on time.
Our teams are flexible, supportive, and driven by diligence and integrity at every stage.
DOWNLOAD THE BROCHURE NOW
What we can provide
Our DMC experience means we’re able to provide a wide variety of DMC offerings, from one-off consultation to full end-to-end Statistical Data Analysis Centre with administrative and logistical support for the DMC, or even DMC statisticians.
As a Statistical Data Analysis Centre we collaborate with the sponsor on the setup of the DMC, independently support the DMC with integrity throughout the trial by providing the required analyses securely through our independent statistician, and at closeout deliver the files and documentation required for the trial masterfile.
Our statisticians and programmers have experience supporting DMCs in this way across a range of therapeutic areas and logistical scenarios, understand the issues inherent in providing analyses for interim decision making on incomplete and often unclean data, and are practiced in ensuring data quality and alignment of DMC and main study analyses whilst maintaining study blind. Our independent statisticians are “hands-on”, developing the deep knowledge of the study and data necessary to oversee reporting to the DMC. Our technology, processes and robust approach to quality ensure effective delivery without compromise.
As a part of our end-to-end service, we are able to take on the burden of administrative and logistical support for the DMC. For example, we can set up and host virtual DMC meetings, make logistical arrangements for secure face to face meetings, manage secure file transfer and storage as well as manage and organise the on-going project management of the DMC process.
Where not otherwise involved in a study we can provide statisticians who are experienced in performing the role of the statistical member of the Data Monitoring Committee (voting or non-voting).
Leading the team
Our team of experts bring over 25 years of experience and are backed up by a diverse pool of dedicated, trusted Statisticians that can add real value to the DMC and the analysis of your clinical data.
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.
Dr Andrew P Holmes, Senior Manager, Statistics & Head of DMC
- BSc in Mathematics, MSc & PhD in Statistics.
- 25+ years experience in clinical biostatistics in academia and industry across multiple therapeutic areas from pre-clinical to Phase IV.
- 20 years DMC experience.
- Trial design, protocol and analysis plans, data standards, programming & platforms, analysis, reporting and publications.
Marie Wagg, Project Manager
- 8 years CRO industry experience
- Experienced in the coordination and management of complex and sophisticated tools, systems and processes
Critical Success Factors
We collaborate transparently during the planning phase of a DMC to ensure absolute clarity on aspects such as charters, roles & responsibilities, specifications, data flows, file transfers, logistics and communications. Our proactive resource planning ensures our teams have the skills and time to efficiently deliver quality with continuity.
We have a team of statisticians with experience working on DMCs across a range of therapeutic areas who are familiar with the unique statistical and logistical issues of interim analyses and DMCs.
Our teams are cognizant of the firewall they provide between sponsor and DMC during a study. 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
Our experienced teams supported by efficient processes and technologies allow us to respond quickly to DMC requests or triggers for meetings, and adapt to data challenges or study changes with agility.
Why choose us?
- Our team of experts have the technical expertise and practical experience you can trust to support DMCs with integrity in any clinical trial across all therapeutic areas, regardless of size or scope.
- We collaborate to ensure clarity during setup, act with integrity to support the DMC during the study, delivering excellence throughout.
- We put people and quality first, proactively resourcing to ensure a continuous team with sufficient skills, support and time to deliver.
- Our strong project management and GCP compliant systems ensure the strict control of the study blind and maintenance of confidentiality.
Get in touch to discuss how we can help.