Online Program

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Friday, September 14
Fri, Sep 14, 9:55 AM - 11:10 AM
Lincoln 5
Considerations for Adequate Representation of Geriatric Patients into Clinical Trials

Disparities in Oncology Clinical Trials (300709)

*Laura Fernandes, FDA/CDER 

Keywords: Subgroups, Drug Trial Snapshot program,

Race, sex, age and other demographic characteristics are routinely collected in oncology clinical trials. Patients are enrolled in a clinical trial to meet strict inclusion/exclusion criteria to make it easier to demonstrate a treatment difference in a homogenous patient population. In practice, when using the drug, most patients are interested in knowing the treatment benefit in demographic subgroups, and in patients like them.

The FDA initiated the Drug Trial Snapshot program to describe the safety and efficacy of new drugs in certain demographic subpopulations enrolled in clinical trials. A day long symposium was conducted in association with ASCO to improve the enrollment of geriatric patients in oncology clinical trials. This talk will discuss some of the results of aggregated demographic data in oncology trials and present some trial designs that could be implemented to improve diversity in clinical trials.