In American patients with advanced non-small lung cancer, how do broader eligibility criteria to participate in clinical trials compare with the eligibility traditionally used?

How can a patient’s opportunities to participate in a clinical trial be increased?

An American study discovered that nearly twice as many patients would be able to participate in research trials if the eligibility criteria to take part were broadened. The  trial results are more likely to be representative of the general public and applicable to the ‘real world’ if this were to happen.

This study was based on de-identified data from 10,500 American patients Electronic Health Records obtained from the American Society of Clinical Oncology (ASCO) Cancer LinQ Discovery database.

Read on to learn how sharing health data can save lives

Why was this work needed?

Researchers generally look to achieve the clearest possible research findings by carefully selecting those patients that are allowed to participate in a clinical trial. For example, large differences in age range, patients with other diseases in addition to the one being studied or differences in how far the disease being studied has progressed could, potentially, complicated matters resulting in less-clear outcomes.

Therefore, researchers often apply ‘eligibility criteria’ to patients interested in participating in a trial. The patient has to meet certain and multiple criteria around their health – a similar in approach to that often used by dating agencies. However, for some types of research this can have the effect of excluding a high proportion of patients. The research results are therefore likely to be less representative of and less effective in the real world.

What did research find?

The purpose of the research was to understand the impact of broader eligibility criteria when compared with the eligibility criteria traditionally used for research on patients with advanced non-small cell lung cancer in the USA.

The research was led by the American Society of Clinical Oncology (ASCO) and other collaborators, based on prior recommendations developed by ASCO and the Friends of Cancer Research (‘Friends).

They considered the data from following aspects of the disease: prior or simultaneous cancers, presence of brain metastases (secondaries) and reduced kidney function.

From the group of 10,500 patients less than half (5,005 patients) would have been eligible for a trial using traditional eligibility criteria. Using the broader eligibility criteria (as specified by ASCO/’Friends’), almost double the number of patients (10,346) would be eligible. In other words, from the group of 10.500 patients only 154 patients would have been excluded from participating.

What was the impact on patients?

Nearly twice as many patients would be able to participate in research trials and research results are therefore likely to be more representative of and effective in the real world.

It is likely that, whilst this research was carried out using data from advanced non-small cell lung cancer, this type of approach could be used in nearly all cancer clinical trials across the world.

This research was presented at the ASCO Annual Meeting in 2019.

What data was used?

De-identified Electronic Health Record data contained from the American Society of Clinical Oncology (ASCO) CancerLinQ Discovery database was used. This data was originally sourced from patient records of routine patient care from around 50 cancer centres and oncology practices in the USA.

Identifiable Electronic Health Record data had originally been collected by ASCO for quality improvement purposes by the 50 participating centres. The collection of this identifiable data is allowable under the Health Insurance and Portability Act (HIPAA) in the USA and therefore it was not necessary to gain patient consent.

The identifiable data was automatically converted into de-identified by software and stored in the ASCO CancerLinQ database. Only de-identifiable data from 10,500 patients was used in this research.

Further information

Scientific research paper: Impact of broadening clinical trial eligibility criteria for advanced non-small cell lung cancer patients: Real-world analysis.

This work uses data provided by patients and collected by the health professionals as part of the care and support provided.