Understanding eligibility criteria for clinical trials to increase study size

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Published: 3 Jun 2019
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Dr R. Donald Harvey - Winship Cancer Institute of Emory University, Druid Hills, Georgia

Dr R. Donald Harvey talks to ecancer at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting about a study looking at aNSCLC patients from ASCO’s CancerLinQ database and understanding their eligibility criteria.

He explains that three main areas were considered in the criteria: the presence or absence of brain metastases, prior or concurrent history of additional cancer diagnosis and the renal function.

Dr Harvey reports that the percentage of patients excluded was 47.7% for the older, restrictive criteria and 1.5% when the criteria was taken away.

Watch the press conference here.

ecancer's filming has been kindly supported by Amgen through the ecancer Global Foundation. ecancer is editorially independent and there is no influence over content.

We took a look at 10,500 patients through the ASCO CancerLinQ database. These patients had advanced non-small cell lung cancer and were stage 3B or higher. The purpose of the analysis was to try to understand eligibility criteria for clinical trials. We looked at three main areas for those criteria – one was the presence or absence of brain metastases, the other was prior or concurrent history of additional cancer diagnosis and finally renal function, specifically looking at the number of 60ml/minute for creatinine clearance as a marker for eligibility criteria historically. We then said, well, if we take those barriers away, meaning we enrol patients with brain metastases, we enrol patients who have a history of a prior cancer and we drop that number of creatinine clearance from 60ml/min to 30ml/min how many would therefore be eligible to participate in a clinical trial?

If you use the older, more restrictive, criteria we excluded 47.7% of patients from eligibility. However, if you take away those criteria that number dropped to 1.5% and so really doubled, more than doubled, the number of patients who would be eligible for trial participation with advanced non-small cell lung cancer.

The purpose of it overall is to make sure that the trials we conduct in that disease and other cancers reflect the patients that we see in clinic and that that data can be used for the generalisability of the information that we gather in trials. It also can accelerate accrual to trials which has the possibility of bringing effective drugs to patients more quickly.