At the 2019 Challenges in Rare Diseases Clinical Trials Symposium and East training, Cytel partnered with Alexion to bring together expertise from academia and industry. David Kerr, Director of DMC Services at AXIO, was among the notable speakers and his talk “Data Monitoring Committees – Behind Closed Doors” covered general considerations and options that the DMC has when reviewing the data presentations during their closed sessions. He presented four specific case studies that highlighted the data provided to the DMC from meeting to meeting and discussed how the DMC arrived at their recommendations for each meeting. We had the opportunity to sit down with David and speak about Data Monitoring Committees, understand their proceedings and talk about his presentation at the symposium.
Cytel: What is the role of a Data Monitoring Committee in a clinical trial?
David Kerr (DK): To protect the safety of current and potential participants in the trial and protect the integrity of the trial while doing so.
Cytel: What do you find most interesting about working with Data Monitoring Committees?
DK: Every study design is different, every DMC interacts differently as a group, and the data evolves differently for every study. Although every DMC meeting has a common goal, which is to make a recommendation about the trial, each DMC meeting is unique. That is how I have stayed fascinated by DMCs throughout my career, attending more than 600 DMC meetings.
Cytel: What is the most important thing for sponsors to understand the proceedings within a DMC meeting?
DK: There are two things really:
- Trust your DMC, don’t micromanage the committee on how to do its job and neither should you hide dirty truths about the study.
- Understand that the Tables, Listings and Figures (TLFs) and the level of data quality needed for the DMC review, it will be different from the TLFs and the level of data quality required for a Clinical Study Report (CSR).
Cytel: Could you give us any insights from “Behind Closed Doors” for someone who’s unfamiliar with the process?
DK: Data Monitoring Committees are very sincere and serious about their role in clinical trials, and this should make potential participants feel comfortable that an independent group is looking out for their well-being. Keeping that in mind, each DMC is a group of individuals and therefore, different DMCs might interpret the data differently. For example, giving the same testimony (think data) to two different juries (think DMC) might result in different verdicts (think recommendations).
Cytel: Are there new and emerging technologies that will affect the way the DMC currently operates?
DK: DMCs should expect an easy-to-navigate report, for example, PDF with bookmarks and/or hyperlinks, that is securely distributed through electronic mediums. TLFs may have innovative elements, such as non-traditional figures, to allow the DMC to quickly digest large amounts of data.
DMCs will also be on the front lines to implement innovative adaptive trial designs, such as dropping dose, sample size readjustment and termination for futility/efficacy. DMC members and the groups that support them will need to provide these reports and facilitate discussion of the adaptive designs.
Click on the button for downloadable copies of the speaker's slides.
About David Kerr
David Kerr received his Master’s in Statistics from the University of Washington and has worked at Axio Research, now part of Cytel, in Seattle for the past 24 years. He currently holds the title of Director of DMC Services where he provides leadership, direction and oversight for all DMC services provided by Axio Research. He was instrumental in developing Axio’s SOPs which govern the company’s DMC Services as well as the specialized statistical programs which produce the materials reviewed by the DMC. In addition to his duties as Director of DMC Services, David has himself provided statistical support as the reporting statistician for more than 100 DMCs covering 150 individual clinical trials, with particular emphasis in disease areas such as oncology, cardiology, infectious disease, respiratory disease, and rheumatology. He has personally attended over 600 DMC meetings, and seen a wide variety of situations from those experiences. He is a strong advocate for improvements in the DMC process and has presented at JSM and SCT and BASS, as well as given tutorials to industry. His goal is to make sure the DMC has the best information available to help them make educated recommendations for the success of the trial and the protection of the study participants.
About Axio, A Cytel Company
Axio Research was established in 1979 by eminent biostatisticians and epidemiologists from the University of Washington and holds a 40-year track record of excellence as an industry leader in Data Monitoring Committee services and other statistical solutions. Leading sponsors have trusted Axio to plan and manage more than 200 data monitoring committee projects across all therapeutic areas. In June 2019, Cytel Inc. and Axio Research joined forces to create the world’s largest biometrics organization focused on delivering advanced analytical solutions for the life sciences industry. The combined expertise of the two companies envisions to address trial sponsors’ toughest drug development challenges and maximize the opportunities offered by emerging data sources.
We will be sharing a video recording of the presentations. Register now to get a copy.