Broader inclusion criteria to double eligible cancer patients for clinical trials, finds study

6th June 2019 (Last Updated June 6th, 2019 18:39)

A study assessing the health records of more than 10,500 patients with advanced non-small cell lung cancer (aNSCLC) from ASCO’s CancerLinQ database found that the use of expanded clinical trial inclusion criteria would nearly double the percentage of eligible cancer patients to enroll in clinical trials.

Broader inclusion criteria to double eligible cancer patients for clinical trials, finds study
On applying expanded criteria method, only 154 (1.5% of patients) did not meet the eligibility criteria. Credit: Marcelo Leal on Unsplash

A study assessing the health records of more than 10,500 patients with advanced non-small cell lung cancer (aNSCLC) from ASCO’s CancerLinQ database found that the use of expanded clinical trial inclusion criteria would nearly double the percentage of eligible cancer patients to enroll in clinical trials.

The study is the result of a joint project between American Society of Clinical Oncology (ASCO) and the nonprofit advocacy group Friends of Cancer Research, which issued recommendations for expanding clinical trial access.

The study involved participation of patients with aNSCLC who had visited oncologists two or more times and had at least one dose of systemic treatment.

CancerLinQ data system collects and analyses real-world data from patients who are involved in the nationwide clinical trials. This data will be used by the researchers to evaluate how many patients would be eligible by traditional criteria versus the expanded criteria recommended by ASCO and Friends of Cancer Research.

The median age group of participants involved in the clinical trials was 67.6, out of which 56% were male and the remaining 44% female.

With the traditional clinical trial criteria, 5,005 (47.7% of patients) patients would not be eligible for enrollment. However, when the expanded criteria method was applied only 154 (1.5% of patients) did not meet the eligibility criteria.

The result demonstrated that use of the expanded criteria would result in nearly twice as many people with aNSCLC being eligible.

ASCO Expert David L. Graham said: “Only about 3% of patients with cancer in the United States currently enroll in a clinical trial, and restrictive eligibility criteria established in an era before advances we have made in supportive care is one reason for this low number.

“This study makes the case for universal adoption of broader clinical trial eligibility criteria, such as that proposed by ASCO and Friends of Cancer Research, so that more lung cancer patients and others have the opportunity to safely participate in potentially lifesaving research.”

In March this year, the US Food and Drug Administration (FDA) issued four draft guidances to broaden criteria for cancer trial eligibility.