Biomarker-driven protocol model broadens lung cancer trial access for some underrepresented groups

As in comparison with standard, stand-alone medical trials in superior non-small cell lung most cancers (NSCLC), the biomarker-driven Lung Most cancers Grasp Protocol (Lung-MAP) has enrolled increased percentages of sufferers who’re older, sufferers who’re from rural or socioeconomically disadvantaged areas, and sufferers who’ve Medicaid or no insurance coverage.

These are a number of the outcomes of an evaluation of the representativeness of the greater than 3,500 patients enrolled to Lung-MAP from its 2014 launch by means of 2020. That work is being revealed within the journal JCO Precision Oncology.

Riha Vaidya, Ph.D., of the SWOG Statistics and Information Administration Middle and Fred Hutchinson Most cancers Middle, is lead creator on the evaluation.

“Lung-MAP is the primary protocol performed inside the NCTN as a public–personal partnership,” Vaidya stated, referring to the Nationwide Scientific Trials Community. “There is no revealed knowledge on whether or not this partnership strategy improves entry to clinical trials over conventionally performed trials. So, our objective was to look at the sociodemographic traits of sufferers enrolled to Lung-MAP and the way they in comparison with different SWOG trials for superior NSCLC.”

The Lung-MAP partnership contains the Nationwide Most cancers Institute (NCI)—a part of the Nationwide Institutes of Well being (NIH)—and its NCTN, together with SWOG Most cancers Analysis Community, and Mates of Most cancers Analysis, the Basis for the Nationwide Institutes of Well being, Basis Medication, pharmaceutical corporations that present their medicine for the research, and several other lung cancer advocacy organizations. The trial supplies an infrastructure for conducting a portfolio of biomarker-driven medical trials in NSCLC below a shared screening protocol.

A gaggle of Lung-MAP researchers got down to decide whether or not the grasp protocol strategy improved entry to trials, notably for teams traditionally underrepresented in medical analysis research.

The crew examined sociodemographic traits for all 3,556 sufferers enrolled to the Lung-MAP screening protocol between the activation of the research in June 2014 and December 31, 2020. They in contrast Lung-MAP participant traits to these from a set of two,215 sufferers enrolled to different, particular person medical trials in superior NSCLC that had been performed by the SWOG Most cancers Analysis Community.

In comparison with sufferers enrolled to different NSCLC research, Lung-MAP sufferers had been extra prone to be 65 years of age or older (57.2 % versus 46.3 %), to reside in a rural area (17.3 % versus 14.4 %), to reside in a neighborhood categorized as socioeconomically disadvantaged primarily based on its Space Deprivation Index rating (42.2 % versus 36.7 %), or to have Medicaid insurance coverage or no medical health insurance (of sufferers youthful than 65, 27.6 % versus 17.8 %).

Sufferers on Lung-MAP, nevertheless, had been much less probably than these enrolled on different trials to be feminine (38.6 % versus 47.2 %), to be Asian (2.8 % versus 5.1 %), or to be Hispanic (2.4 % versus 3.8 %). In explaining the underrepresentation of feminine sufferers, the authors word that earlier than 2019, Lung-MAP enrollment was restricted to sufferers with squamous cell carcinoma, a tumor histology that’s considerably extra widespread amongst males.

“Our discovering of improved entry to medical trials for some underrepresented affected person teams supplies a possibility to look at how we will apply web site and affected person engagement practices from Lung-MAP to different trials so we will attain extra sufferers,” Vaidya stated. “We’ve extra work to do, notably relating to illustration of racial and ethnic minority teams. SWOG’s DEI infrastructure will probably be vital in figuring out and resolving boundaries to trial entry for these affected person teams.”

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