Fred Hutch’s health services researcher Joe Unger, PhD, MS, working with the American Society of Clinical Oncology (ASCO), the U.S. Food & Drug Administration (FDA) and the Friends of Cancer Research, published a study last week that found clinical trials have started to modify eligibility criteria to be more inclusive of patients with brain metastasis, per the collaboration’s 2017 task force recommendation.
Unger and others evaluated more than 3,000 interventional clinical trials for metastatic breast, colorectal, lung and skin cancers (melanoma) held between 2012 and 2022. Overall, they found the proportion of trials not excluding patients with brain metastasis increased from 11.5% to 17.3% and that those “conditionally excluded” decreased from 82.3% to 75.2%.
All in all, Unger and others found the ASCO/FDA/FOCR task force recommendation was associated with a “shift in patterns of brain metastases … to not excluded.” Further, they said their findings demonstrate the “cancer clinical trial community has begun to change the way trials are written to be more inclusive.”
In another study published this week in the Journal of Clinical Oncology and conducted with the American Cancer Society Cancer Action Network and other institutions, lead author Unger and collaborators found that when participation in all types of cancer research studies are considered, at least one in five people with cancer in the U.S. (nearly 22%) participate in some form of clinical research.
“As we work to increase participation in cancer research studies and make them more accessible to patients, we need an inclusive, accurate assessment of current participation to inform these policies,” Unger said. “While we knew that patients play a significant role in advancing all types of cancer research, now we better understand just how commonly people are participating in all types of cancer studies today.”
Unger also praised patients with cancer for their contribution to medical research.
“These contributions are much more extensive than was previously recognized,” he said. “Cancer clinical research is a true partnership between those with cancer and those who study and treat cancer.”
Diane Mapes is a staff writer at Fred Hutchinson Cancer Center. She has written extensively about health issues for NBC News, TODAY, CNN, MSN, Seattle Magazine and other publications. A breast cancer survivor, she blogs at doublewhammied.com and tweets @double_whammied. Email her at dmapes@fredhutch.org. Just diagnosed and need information and resources? Visit our Patient Care page.
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