Demographic Composition of Select Oncologic New Molecular Entities Approved by the FDA Between 2008 and 2017

Area of Science:

• Oncology
• Clinical Pharmacology
• Health Disparities

Background:

• Demographic factors like race, ethnicity, sex, and age significantly impact drug efficacy and patient outcomes.
• Certain cancers, including breast, colorectal, lung, and prostate cancer, exhibit varying morbidity and mortality rates across different demographic groups.

Purpose of the Study:

• To analyze demographic subgroup enrollment patterns in new therapeutic products approved by the US Food and Drug Administration (FDA) for select cancers.
• To identify potential under-representation of minority populations in pivotal clinical trials.

Main Methods:

• Review of participant demographics (race, ethnicity, age, sex) in new cancer therapeutic product submissions to the FDA.
• Analysis of enrollment data for products approved between 2008-2013 and 2014-2017.

Main Results:

• Between 2008-2013, trials (n=22,481) comprised predominantly white (80%) and male (56%) participants, with most from outside the US (74%).
• Between 2014-2017, trials (n=3,612) continued to show a majority of white (71%) and male (48-63%) participants, with under-representation of US minority populations.
• Age distribution showed 59-61% of participants were between 17 and 64 years old.

Conclusions:

• Clinical trials for major cancer therapeutics show persistent under-representation of US minority populations.
• Increased diversity in patient subgroups within clinical trials is essential for a comprehensive understanding of drug exposure and response variability.
• Broader demographic representation can facilitate personalized drug therapy and improve cancer treatment outcomes across diverse populations.