5:36 PM
Jun 07, 2019
 |  BioCentury  |  Product Development

ASCO 2019 sessions provide guidance on expanding patient pools for clinical trials

Perspectives from ASCO on how to match more patients to trials

Two sessions at this year's American Society of Clinical Oncology meeting gave drug developers a glimpse of how to match more patients to clinical trials by broadening eligibility criteria and encouraging trial enrollment in community settings.

Both measures could increase patient enrollment, especially in rare indications or those where enrollment at academic centers is competitive, and they could increase access to patients who better reflect the diversity in the real world.

According to ASCO presenters and panelists, more than 80% of patients live near a community hospital or practice, but only about 3-5% of them enroll in a clinical trial compared with 7-10% of patients living near an academic hospital.

"Community is a very, very viable option. Pharmas should not necessarily go back to the same well over and over again hoping that the patients show up," Carla Balch, CEO of Inteliquet Biopharma, told BioCentury. Inteliquet, which uses real-world data to find and match patients with clinical trials, presented at a separate ASCO session.

“Sponsors need to choose sites based on the data -- where are the patients? We know where the patients are,” said Balch.

Balch was previously CEO of Altos Solutions, which Flatiron Health acquired in 2014 for its oncology-specific medical record system, OncoEMR.

While the panelists at the two sessions were largely from community hospitals and ASCO working groups, pharmas have started demonstrating movement on these topics in the last year, through partnerships with community hospital networks and digital health companies designing site-less trials.

FDA is on board with both ideas and has taken steps to support broadening of inclusion criteria and research in community clinics.

In a March statement, former FDA Commissioner Scott Gottlieb said, “Some eligibility criteria have become commonly accepted over time or used as a template across trials without a clear scientific or clinical rationale or justification. In other cases, eligibility criteria can be deliberately restrictive, even though it is not clinically merited.”

FDA published five guidance documents in March and another on June 6 to expand eligibility criteria for...

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