July 11 2024
Article by Lisa Taylor an NRG Oncology Patient Advocate on the Data Management Committee (DMC)
NRG’s Data Management Committee (DMC) reviews NRG trials in progress to make sure that continuing a trial is both scientifically sound and ethically responsible. Based on that review, the DMC makes a recommendation to the NRG Group Chairs to continue, terminate, or pause a trial; the ultimate decision is made by those Group Chairs. To me, the DMC helps deliver relevant trials, executed safely, without undue delay.
The NRG fields two DMCs that monitor ongoing Phase 2 and 3 treatment trials, with each Committee covering a specific set of tumor types. I serve on DMC A, which covers gynecological, breast, and gastrointestinal cancers.
Our semiannual DMC meetings consist of 3 sessions—open, closed, and executive—and we receive between 150 and 300 pages of material to review before each meeting. During my tenure, we’ve monitored between 13 and 24 trials at a time.
In the open session, NRG Biostatisticians review the trial design and present a summary of each active study that is an “open label trial”, meaning the trial where participants and researchers both know which treatment is being administered. Occasionally, during this session we discuss non-accruing open label trials if there is an interest. The meeting includes both voting and non-voting members of the DMC, and sometimes the research physicians and staff who are implementing a particular trial at their institutions.
Our discussions cover the status of recruitment—including the impact of competing trials or new approvals--and how to boost recruitment, if needed. We also review the demographic data for each arm of the trial, and when to expect the outcome data. Our strongest focus is on the safety data, and we look not only at the type of adverse events (AEs) but also at their severity, and whether these AEs are unanticipated given what is known about the drugs under study. We may also ask questions of the trial-related personnel.
In this open session, I comment most often on what will affect the speed of both the trial completion and the release of the data. Specifically, I look at whether recruitment is going according to schedule, and at the proportion of patients whose assessment data is not yet logged into the trial database.
In our closed session, we review unblinded data on ongoing trials, including those with planned interim analyses, which is a review of the available data from an ongoing clinical study prior to the actual completion of data collection to determine how a study is performing. As we do in the open session, we examine recruitment and patient demographics, but primarily focus on the safety data, and discuss the interim efficacy and compliance data in detail with the protocol statistician(s) when we have it. For the AE reports, we consider attribution, grade, and we review detailed reports of the most severe events as available. As an advocate, I examine all degrees of adverse events as well as the impact of those events on quality of life.
Finally, in our executive session, the voting and non-voting members discuss all trials we monitor and vote on our recommendations for each. We may:
- Ask for more data
- Suggest modifications to the trial design or to management of specific AEs
- Recommend that a trial continue as planned, or advise that it be stopped
If we advise stopping, reasons may include recruitment that seems unfeasible or a safety or efficacy concern. In that case, I focus particularly on what course we should recommend for the patients who are doing well on that trial. In rare cases we may recommend stopping because the interim analysis shows the study arm is superior to the standard-of-care arm.
If you look at the makeup of the NRG Patient Advocate Committee, you’ll see that collectively we are diverse, not only in our lived experiences, but also in our professional training and the areas of advocacy that interest us. My role on the DMC is reflective of my personal and professional strengths and interests. For example, in evaluating the data, I draw most often on the clinical trial design and statistical analysis lectures I attended as a Faculty member for the AACR/ASCO Methods in Clinical Cancer Research Workshop, my degree in Human Biology from Stanford, and on my day job working with small biotech startups on company strategy and the information they need to make decisions about initiating a trial.
Over the course of my involvement with this committee, I have been extremely impressed with the clinicians and statisticians I have worked with on the DMC, not only in the depth of their individual experience and the breadth of their collective knowledge, but in the collaborative nature and creativity of our discussions. I am honored to be a member of the DMC.
About the Author
Lisa Taylor is a long-time NRG Patient advocate, having joined the Gynecologic Oncology Group in 2007. She has served on the Developmental Therapeutics and Uterine Corpus Committees, as well as on NCI’s Uterine Cancer Task Force. In addition to her work as a faculty member at the Vail Workshop, Lisa has made various patient-focused presentations at the annual Accelerating Anticancer Agent Development and Validation (AAADV) Workshop.She is also a reviewer for JAMA Oncology. Lisa was catapulted into patient advocacy by her mother’s diagnosis of ovarian cancer and continues to help individuals navigating their way through diagnosis and treatment.