Winship Cancer Institute of Emory University researchers conducted a retrospective study based on real-world data that revealed that if clinical sponsors expanded the inclusion criteria for NSCLC trials they could double the number of trial participants helping all: the sponsor, the investigator and patients in dire need of care.
The recent findings produced by R Donald Harvey and research colleagues presented their findings recently at ASCO Chicago 2019.
The Emory University-based team analyzed the effect of using broadened trial criteria in which—unlike traditional criteria—patients with previous or concurrent cancers, brain metastases, or limited kidney function (creative clearance ≥30 mL/min) would secure far greater eligibility as Catherine Booth reported in MedWireNews.
CancerLinQ Leads to Results
The team leverage the powerful data in ASCO’s CancerLinQ Discovery database (powered in part by SAPs Hana next generation database technology). The team probed electronic health records for 10,500 patients with advanced NSCLC (lung cancer) and found 5,005 (47.7%) that would be excluded from trial participation under traditional criteria, compared with just 154 (1.5%) under the broadened criteria. This translated to an increase in the trial population from 5495 (52.3% of patients in the database) to 10,343 (98.5%).
The growth of patient participation includes a majority of those 75 and older, with the population of such patients jumping from 16.1% (traditional) to 22.2% (broadened criteria); the median age increases from 66.1 to 67.5 years old.
The broadened criteria leads to a more representative sampling of the broader patient population. Clinical sponsors need to consider broadening the inclusion criteria now—“narrower criteria to exclude patients should only be used based on compelling scientific rational.” Ms. Booth included ASCO expert comments from David Graham of the Levine Cancer Institute, who stated, “This study makes the case for universal adoption of broader clinical trial eligibility criteria so more lung cancer patients and others have the opportunity to safely participate in potentially lifesaving research.”
TrialSite News believes the time for cancer research as a care option is now. Many of the roadblocks in the way are created by conservative, risk-averse institutions more concerned about avoiding lawsuits than truly helping patients and progressing science. Time for that to change. It takes leadership, a clarity of conviction of what the right thing to do actually is. Put a strategy in place and execute. The time is now for universal adoption of broader clinical trial eligibility criteria in cancer trials.