By Peter J. O’Dwyer, MD (left)
and Mitchell D. Schnall, MD, PhD

We are well-established into the year 2023, and the Year of the Rabbit, with ECOG-ACRIN activities focused on a multitude of trial activations, advances in correlative research and the structures to support it, and engagement with NCI as the Division of Cancer Prevention (DCP) launches a dedicated Cancer Screening Research Network in which we plan to participate with enthusiasm. Two key committees met for the first time at the Fall 2022 Group Meeting: the Data Science Committee and the Real-World Data Working Group. The former brings together expertise in clinical data, genomics, pathomics, radiomics, and patient-reported outcomes to allow state-of-the-art analyses of our trials.

The scrutiny of clinical data collected on our trials has been a topic at NCI and FDA for some time now. Much of the information captured on our case report forms is never used and contributes little to establishing the safety of new therapies. We fully agree that paring back data collection to meet the endpoints of the trial will decrease both the burden on sites and patients as well as the cost of the research. A concern, however, is in collection of baseline data. Candidly, we know very little about the patients treated on our studies. If diversity of accrual is a goal, how can we know if we are making progress without information on diversity? We classify patients according to race and ethnicity, but we do not collect sufficient information to assess BMI, or any of several aspects of the patient in their environment that would be informative as to both the kind of tumor that they harbor and their response to treatment. As we explore ways to better understand our patients, we welcome suggestions and guidance as to how to do this without adding burden at our institutions.

The issue has been further highlighted by a recent FDA RFA to set up cooperative agreements for the acquisition and analysis of real-world data in order to provide evidence of the effectiveness of novel therapies beyond the restricted populations that comprise the phase 3 trials upon which FDA approval was based. Recognition of this aspect of our therapeutic mission through the Real-World Data Working Group, led by Dr. Al Benson, should serve as a focus for innovative research in this arena, and we welcome your participation. In particular, this is an activity of special relevance in the community setting as much as in academic sites, and the practical implementation of real-world data studies will depend on your insights.

We view these efforts plus the expanded focus on screening—especially with Multi-Cancer Detection (MCD) blood tests—as continuing priorities for ECOG-ACRIN. NCI has issued three RFAs to establish a network through which to complete these studies. ECOG-ACRIN has a strong history of screening trials that dates back 20 years, and we have two large screening studies underway (read the TMIST update in this issue). The cooperative groups are in the best position to manage and implement this work, and our sister groups are entirely in accord. We look forward to having key roles in these studies going forward. The first initiative will be a trial called Vanguard, which will assess feasibility of the approach in some 24,000 participants. Wisely, DCP is holding off on finalizing design and other issues until the network is assembled, and we will share with you details of this initial study as they become available. We have a busy year ahead!

Read the February 2023 issue here.