Online Program

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Thursday, September 13
Thu, Sep 13, 11:45 AM - 1:00 PM
Various Rooms
Roundtable Discussions

TL24: Disparities in Oncology Clinical Trials (300622)

*Laura Fernandes, FDA/CDER 

Keywords: subgroups, race disparities, oncology, clinical trials

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. This roundtable will discuss challenges in translating the treatment benefit in underpowered subgroups, the need for enrolling patients in certain racial and age subgroups to match the disease incidence of cancer sub-types, and the efforts to improve diversity in clinical trials.