Independent Data Monitoring Committee (IDMC)
An independent data monitoring committee (IDMC) or data and safety monitoring board (DSMB) can play a vital role in protecting patients enrolled in a clinical trial from harm. An IDMC may also review of interim efficacy outcomes in trials with early stopping rules or adaptive designs.
Sponsors benefit from an IDMC because the independent reviews can ensure trials of effective interventions have the best chance of success while trials of ineffective or unsafe interventions can end with minimal risk to patients. DCRI’s approach advances these aims by providing the right data to answer the right questions at the right time, avoiding overly lengthy clinical research that can bog down a committee’s work.
The DCRI has more than 30 years of experience supporting IDMC activities. Since 2012, we have provided IDMC support to 52 projects (45 individual trials and 7 programs) in multiple therapeutic areas.
The DCRI and Duke helped launch the Clinical Trials Transformation Initiative (CTTI), helping to define and deliver improvements in IDMC formation, activities, and governance. As founding members of the CTTI, we are committed to its recommendations for improvements in IDMC organization and operations.
The DCRI offers experienced teams of biostatisticians and programmers who work in partnership with Duke University faculty experts on IDMC activities. A project team typically includes:
- Faculty/reviewing biostatistician
- Lead biostatistician
- One or more statistical programmers
- IDMC coordinator
The DCRI can provide sponsors and study leadership:
- Identification of IDMC members
- Management of IDMC member contracting and payments
- Development of IDMC charter
- Creation of the Statistical Analysis Plan (SAP)
- Execution of the SAP
- Consultation on design and interpretation of statistical analyses
- Coordination of IDMC meetings, minutes, and meeting documentation
- Attendance at IDMC meetings to present statistical analyses
- Archiving of IDMC materials
Working with DCRI Biostatistics Resources
Faculty/Reviewing DMC statistician
Oversight by the faculty/reviewing statistician results in greater assurance that analyses produced are accurate and valid. Understanding that DMC recommendations can have a major impact on trial operations and expense, DCRI views faculty-level oversight as an important factor positively affecting both the quality and efficiency of trial conduct. The faculty/reviewing statistician:
- Reviews and approves the detailed SAP and DMC reports
- Is an expert in statistical computing and guides the lead statistician in the choice of appropriate statistical routines to use
- Has experience with interim data and is able to identify appropriate supportive, exploratory, or sensitivity analyses which assess the strength of any inferences which might be made from interim data
- Through ongoing interaction with the lead statistician, has sufficient knowledge of the operational aspects of the DMC to substitute for the lead statistician, if needed, for example in presentation of the analyses to the DMC or in activities related to unblinding
Lead DMC Statistician
- Drafts the detailed SAP (directed by the charter and the DMC members). Note that the detailed SAP includes instructions for any data derivations as well as programming specifications for tables, listings, and figures
- Reviews interim data for quality and completeness and informs the DMC of potentially important concerns
- Controls unblinding per DCRI statistics standard operating procedures
- Makes certain DMC analyses and QC documentation are produced in a timely manner
- Disseminates analyses to the DMC, as directed by the DMC Chair
- Presents analyses at DMC meetings, and answers specific questions about the data (such as individual case results, or summaries by subgroup)
- Participates in the taking of minutes from each meeting
- Oversees archival of analyses and data
- Program and validate analysis datasets
- Program and validate statistical output related to the DMC analyses
- Perform data transfers
Collaborative Partnerships and Access to Members
The DCRI has collaborated on trials with a wide range of sponsors and study leaders from both industry and the public sector.
In addition, the DCRI’s affiliation with Duke University provides access to many global therapeutic leaders. This internal access serves as a tool for identification of members who will serve on IDMCs. The DCRI has access to more than 100 potential members external to Duke from around the globe.