Data Monitoring Committee (DMC) Services
Ensure Independent, Expert Oversight of Clinical Trial Data
Leverage a worldwide network of experienced biostatistical and medical experts to provide the appropriate independent oversight to support participant safety and statistical evaluations.
Advarra provides trusted oversight of clinical trials needing an independent data monitoring committee (DMC) (also known as a data safety monitoring board [DSMB]) consistent with US FDA and EU EMA guidelines.Get Started
When Is DMC/DSMB Review Required?
Independent DMC or DSMB review and oversight is essential for mitigating risks to study participants and ensuring certain types of trials have adequate data safety monitoring plans. US FDA regulation and GCP E6 R2 requires sponsors to have adequate data safety monitoring plans in their clinical protocols. Guidance from US FDA and EU EMA indicate an independent DMC is an effective and appropriate way to provide an adequate safety monitoring plan for clinical trials where:
- The study endpoint is such that a highly favorable or unfavorable result, or even finding a futility at an interim analysis, might ethically require study termination before its planned completion.
- There are reasons for a particular safety concern; for example, if the procedure for treatment administration is particularly invasive.
- There is prior information suggesting the possibility of serious toxicity with the study treatment.
- The study is performed in a potentially fragile population such as children, pregnant women, the very elderly, or other vulnerable populations, such as those who are terminally ill or of diminished mental capacity.
- The study is performed in a population at elevated risk of death or other serious outcomes, even when the study objective addresses a lesser endpoint.
- The study is large, of long duration, blinded, or multi-center/multi-national and would benefit from additional oversight.
If your trial has any of these attributes, establishing an independent DMC or DSMB is likely in order and may be required by the IRB, ethics committee (EC), or regulators.
Learn about the process of establishing an independent DSMB or DMC.
Biostatistical Expertise for Every Program
With a worldwide network of over 1,500 biostatisticians, medical experts, and other clinical professionals, we have deep expertise in all therapeutic areas, trial designs, and complex biostatistical endpoints.
We work with you to determine the right membership for your data monitoring committee, while operating independently to eliminate any suggestion of conflict.
Want to Become a Data Monitoring Committee Member?
Advarra is always seeking additional experienced biostatisticians and medical experts to serve on our committees. Committee members across the world assist on a part-time basis with DMC reviews and biostatistical-related projects.
Barbara Schneider, PhD, MBA
Executive Director, Biostatistical Services
Barbara Schneider is Executive Director of Biostatistical Services at Advarra. She heads Advarra’s independent data monitoring committee and endpoint adjudication services, which provide trusted safety oversight for hundreds of clinical trials around the world. Prior to joining Advarra, Schneider was the founder and CEO of Watermark Research Partners. Watermark was the first company to provide independent data safety monitoring board services and endpoint adjudication to the clinical trial industry. (Watermark joined Advarra in 2021.)
Data Monitoring Committee Services
- Independent committee formation administered by Advarra
- Collaborative development of DMC charter and member selection with sponsor or contract research organization (CRO)
- Recruitment and staffing of qualified biostatistical and disease condition experts
- Secure data exchange management
- Establishment of secure data transfer
- Programming of statistical charts and methods per DMC charter
- Convene meetings for interim analysis
- Active collaboration with sponsor/CRO on safety or design issues
- Rapid production of DMC recommendations and report to sponsor/CRO
- Year-round compliance management
- On demand meeting services
- Sponsor/CRO training on DMC process
- Data safety monitoring plan development consulting for clinical protocol
- Biostatistical design consulting for efficient endpoints
Leverage decades of statistical experience to help design your overall DMC statistical analysis plan (SAP) for the protocol. Our experts will design and customize a solution to meet your planning and implementation needs.
Our experts provide the necessary programming and validation to complete the tables, listings, and graphs (TLGs) necessary for the DMC.
- Develop DMC SAPs
- Create SAS-derived dataset programs
- Create TLG programs
- Validation of SAS programming per 21 CFR Part 11 standards
- Prepare periodic statistical reports for the DMC per SAP
- Serve as unblinded statistician(s) on the DMC
While our DMC Statistical Center typically works with the Advarra-administered DMC, we can also prepare TLGs for DMCs administered by other parties.
DMC / DSMB FAQ
What is a data monitoring committee (DMC)?
A DMC or DSMB is often a requirement for clinical trials. The DMC is an independent group of experts that conduct a periodic review of accumulated data during a clinical trial. The primary purpose of the DMC is to report early evidence of benefit or harm, taking into account the safety of the participants and the integrity and validity of the data. The key to an effective DMC is truly independent members. DMC members should not have conflicts of interest that may compromise an unbiased review and recommendation to the sponsor.
What is the difference between a DMC and a DSMB?
The terms DMC and DSMB are essentially synonymous and used interchangeably. The US FDA and EU EMA guidelines both use the DMC’s terminology; however, in practice, these committees are typically called DSMB or independent safety monitoring boards (ISMB). Also, the DMC terminology is more common in the EU, while DSMB is the term most common in North America to describe these independent committees.
What is a DMC or DSMB charter?
The charter defines the overall procedure the committee will follow. Each clinical trial is unique, so the DMC overseeing the trial is created with that specific trial in mind. The charter outlines, among other key elements, how the DMC will conduct its review, the committee membership requirements, meeting timelines, and most importantly, the specific statistical methods used to prepare data for the committee to review.
At Advarra, the charter is created collaboratively with the sponsor or CRO and is a key part of our rapid DMC startup process.
Who serves on a DMC?
While regulatory agency guidelines do not mandate a specific committee composition, all Advarra DMCs follow industry best practice and are typically comprised of:
- Five or more total members who collectively have the expertise to assess the interim statistical data and risks associated with the clinical trial.
- At least two members who are experienced biostatisticians.
- At least one member with specific scientific and medical expertise to evaluate safety.
- At least one non-scientifically trained member to represent the general perspective of research participants.
DMC membership varies based on the nature of the protocol, and final membership demographics are outlined in the DMC charter in collaboration with the sponsor or CRO.
During the trial, the DMC convenes meetings at the frequency outlined in the charter. After the meeting, Advarra provides the DMC’s recommendations to the sponsor/CRO within 1 business day.
Setup time for your study’s DMC or DSMB will depend on the nature of the trial and complexity of programming the statistical tables for presentation to the DMC members. Typically, this process takes a month or more, and is completed in advance of the study activation and first patient visit. The sooner you start the process, the less likely it will impact study startup.
day or less
from meeting to delivery of DMC recommendations
Understanding how to Build and Leverage a DSMB Statistical Plan
Find out about the DSMB statistician’s roles, how study design can impact DSMB analysis, and what goes into a DSMB statistical plan.
What Goes into a Charter for DSMB or Endpoint Adjudication?
This blog outlines the key elements of a DMC/EAC charter document, explaining its importance in conducting safe and compliant research.
Data Monitoring Committee Info Sheet
Designing your data monitoring committee to provide the appropriate oversight to support participant safety and statistical evaluations.