Representation of sex, race, and ethnicity in pivotal clinical trials for dermatological drugs.

ABSTRACT:

Background

It is of paramount importance that clinical trials are designed with adequate health equity considerations to prevent disproportionate analyses of specific demographics.

Objective

In this study, we investigated the representation of sex, race, and ethnicity in pivotal clinical trials for drugs with dermatological disease indications approved by the U.S. Food and Drug Administration between 1995 and 2019.

Methods

Thirty-six novel drugs with indications to treat dermatological diseases, approved by the U.S. Food and Drug Administration between January 1995 and December 2019 were abstracted from Drugs@FDA. The drug approval label, statistical review, official record, and trial publication were reviewed for data on disease indication, approval year, pathway, nu

SUBMITTER: Ding J 

PROVIDER: S-EPMC8484973 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature