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

As the new academic year gets into full swing after the summer, ECOG-ACRIN activities are ramping up in committees, in new protocol and grant submissions, and in activities related to our two major NIH grants (cooperative agreements) for the National Clinical Trials Network (NCTN) and the NCI Community Oncology Research Program (NCORP). At the same time, we are in the final planning stages of our Fall Group Meeting in Fort Lauderdale, the commitment for which goes back to the early days of the pandemic. The meeting starts the day after Election Day. We mention this to remind you that your voting plans may be affected, and advance planning may be needed!  We also want to draw attention to the Comis Translational Science Symposium, which will occur as usual on the first day of the meeting. The spotlight this time is on inflammation as a cause of cancer, and as a target for cancer prevention and screening. We expect that, as with previous symposia, proposals for interventions directed at relevant patient populations will be of high interest. We look forward to seeing you there.

As we are all aware, the current structure of NCI funding is such that we were extended with flat funding for the current grant year, and our grant applications were deferred for about a year—hence the renewed focus on our resubmissions. The first Request for Applications (RFA) is due to be released this month, and part of the fall meeting will be devoted to refining the proposed elements. We look forward to comments and criticisms of all of our activities so that we may best represent our very dynamic cooperative group. Please provide feedback to us regarding what you like, what you want to see improved, and what priorities we may be missing. In particular, we would like to hear from the constituencies that make up the membership of ECOG-ACRIN.

Dr. Kimryn Rathmell, the NCI Director, has proposed a budget for FY2026 that allocates over $500 million in additional funding for clinical cancer research. Included in this allocation is a commitment to expanding community involvement by facilitating processes at community sites. Part of this has already begun with the establishment of a Virtual Clinical Trials Office to assist with screening and enrollment. It is our intention to work with these new frameworks, with the understanding that all interventions to accelerate completion of our trials will get novel treatments to patients faster. How can we make ECOG-ACRIN trials easier to implement, especially in community practices?

A trend in recent years has been an increase in eligibility and exclusion criteria that results in higher proportions of screen failures and a less representative patient population. At the same time, the number of in-study procedures and consequently data points has increased exponentially. There is general agreement that this trajectory is unsustainable. Many institutions, especially in resource-poor areas, are simply unable to meet the intensity of the effort needed. In response to a review of clinical trials by Friends of Cancer Research (Friends) and the American Society of Clinical Oncology (ASCO), broadened eligibility criteria were implemented for NCI-sponsored trials beginning in 2022. These changes have brought the populations tested, especially in phase 3 trials, closer to the general population, closer to the “real world.”  Again with Friends support, the institution of the Pragmatica-Lung Trial led by SWOG has simplified trial design further, and a key focus of the Clinical Trials Innovation Unit established by Dr. Monica Bertagnolli is on increasing the pragmatism of our trial portfolio. By employing simple questions and streamlined designs to get fast answers, it is hoped that we can accrue a higher proportion of patients with cancer into clinical trials.

This joint focus on the design of the trials and the institutions accruing patients creates opportunities for greater efficiency and patient engagement. It underlies our increasing efforts in developing real-world evidence to complement clinical trials, to help tailor treatments to patients not represented in the key phase 3 trials, and to create an environment in which we can learn from more than the current 3% of patients who participate in this research. More about this in future issues.

Read the September 2024 issue here.