Diane M Dragaud
Director of Communications
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March 19, 2021
Background: The public statement below relates to the Tomosynthesis Mammographic Imaging Screening Trial (TMIST), an ongoing breast cancer screening trial being conducted by the ECOG-ACRIN Cancer Research Group. On Wednesday, March 17, 2021, the Clinical Trials and Translational Research Advisory Committee (CTAC), an oversight group external to the National Cancer Institute (NCI), voted unanimously to accept the recommendations of an ad hoc working group formed last September to provide advice on TMIST and other NCI-sponsored cancer screening trials. The full report is publicly available here.
Statement to Reporters and the Public
The ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) appreciates CTAC’s unanimous vote to continue the landmark Tomosynthesis Mammographic Imaging Screening Trial (TMIST). We look forward to building on TMIST’s tremendous momentum and working with the National Cancer Institute (NCI) to arrive at study modifications.
ECOG-ACRIN is pleased that the working group unanimously acknowledges the strength of TMIST’s randomized controlled trial (RCT) design, and specifically, that observational studies cannot take the place of an RCT to determine the best breast cancer screening approach. Also, the working group highlights distinct advantages of TMIST over similar European RCTs, including:
The working group also acknowledges successful TMIST site and participant recruitment strategies resulting from our ongoing collaboration with the American College of Radiology®. Since July 2020, TMIST has enrolled more patients than any other NCI trial. About 42,000 women are currently participating. Monthly enrollment in the last five months is higher than at any point in study history – with March accrual (>2700 expected) on pace to be the best month yet. Despite the COVID-19 pandemic, TMIST enrollment increased 700% since January 2019, and the number of participating sites nearly doubled from 59 to 108. We continue to recruit new sites to join the trial.
At a time when the nation is working to address inequities in healthcare, TMIST is recruiting one of the most racially diverse populations of any NCI trial. Currently, 19% of U.S. women in the study are Black, whereas the average Black cohort in U.S. clinical trials is 8%. TMIST funding provides payment for mammography screening for trial participants who qualify for charity care. TMIST may be the only way for many of these women in underserved and rural communities to access routine screening.
We look forward to working with all involved to continue TMIST’s momentum and reach study goals.