Demographic Gaps and Requirements for Participation: A Systematic Review of Clinical Trial Designs in Hidradenitis Suppurativa.

ABSTRACT:

Background

Hidradenitis suppurativa (HS) is a chronic inflammatory disease that disproportionally affects women, as well as Black and biracial individuals. While adalimumab remains the only therapy approved by the Food and Drug Administration for HS, many HS clinical trials for novel and re-tasked therapies are ongoing or upcoming. To optimize treatment equity, reflect the patient population, and facilitate trial participation, it is important to elucidate aspects of clinical trial protocols that may systematically exclude specific patient groups or impose hardships.

Objective

The study aimed to systematically review inclusion and exclusion criteria as well as participant demographics in HS clinical trials.

Methods

A literature search of PubMed, Embase, Cochrane Centr

SUBMITTER: James JF 

PROVIDER: S-EPMC9946439 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature