This week, we officially launched our Data Monitoring Committee (DMC) service. This is an exciting step forward as we grow globally and expand our service offerings for clients across the pharma-biotech industry. We are now able to provide an end-to-end DMC service that focuses on the core aspects of a DMC – from helping set up committee members and the DMC charter to trial analysis, on-going administrative management and final filing at closeout.
However, understanding the need for a Data Monitoring Committee and how it operates can sometimes be confusing. In fact, there are multiple services with differing acronyms that provide the same or similar function, such as a DSMB (Data Safety Monitoring Board), DSMC (Data & Safety Monitoring Committee), and IDMC (Independent Data Monitoring Committee) – all of which are primarily focused on serving two key elements: patient safety and trial integrity.
So what is a Data Monitoring Committee (DMC)?
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. Essentially, the DMC protects the safety of participants and the scientific integrity of the study and ultimately advises the sponsor on study modification, continuation or termination. To avoid any bias from the sponsor, the DMC acts as an external party to the trial and is 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 remaining blind and unbiased.
When is a DMC needed?
There are many cases where a DMC is required, such as clinical trials for life threatening diseases or of treatments with particular safety concerns. A strong early indication of a favourable or unfavourable result may mean it is unethical to continue with one or more treatments, which can be the case in late phase Oncology trials. Therefore, interim assessments are needed through a DMC in order to protect the safety of ongoing and future trial participants.
DMCs are also used when 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 an independent Data Monitoring Committee to assess unblinded/aggregate safety and efficacy results whilst the study overall is blinded.
What can Veramed offer in a DMC service?
We provide an end-to-end DMC service that is built on diligence and integrity. Our team brings years of experience and a strong reputation for delivering high quality DMC support and analysis to the market. Our DMC service is here to suit the needs of the trial and client, providing anything from one-off consultation to a full independent Statistical Data Analysis Centre with administrative and logistical support for the DMC, or even DMC statisticians.
Where our previous DMC service delivered independent Statisticians to support the DMC and provide unblinded analysis to the trial data, we are now able to better facilitate the entire DMC process – from planning/setup to on-going administrative support, unblinded trial analysis, and feedback.
Our team of experts have worked on DMCs across a range of therapeutic areas and are familiar with the unique statistical and logistical issues of interim analyses and DMCs. As the clinical data specialist with people at its heart, the very nature of a DMC service also reflects our ethos – in putting patients and the integrity of a clinical trial above all else. This is one of the reasons why we are excited to develop our DMC offering into a robust DMC business unit that will continue to expand and build for years to come.
To learn more about our DMC business unit, simply click here or get in touch with us directly below.
