Related Experiment Video
Updated: Aug 28, 2025
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Demographic Gaps and Requirements for Participation: A Systematic Review of Clinical Trial Designs in Hidradenitis
JaBreia Fanita James1, Victoria M Madray1, Nicole Salame2
1Medical College of Georgia, Augusta University, Augusta, Georgia, USA.
Insights
Clinical trials for hidradenitis suppurativa (HS) often exclude diverse patient groups and lack demographic data. Future trials need broader criteria and pragmatic designs to improve equity and participation for all HS patients.
Area of Science:
- Dermatology
- Clinical Trials
- Health Equity
Background:
- Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition disproportionately affecting women and minority groups.
- Current HS treatment options are limited, with adalimumab being the only FDA-approved therapy, necessitating ongoing research into new treatments.
- Clinical trial protocols may present barriers to participation for specific patient populations, impacting treatment equity.
Approach:
- Systematically reviewed inclusion/exclusion criteria and participant demographics in 23 randomized controlled trials (RCTs) for HS.
- Searched major databases (PubMed, Embase, Cochrane, Web of Science) for English-language RCTs with at least 10 participants.
- Two independent reviewers screened titles/abstracts and extracted data, with a third reviewer resolving disagreements.
Key Points:
- A total of 1,496 adult participants were included across 23 trials.
- Race and ethnicity data were missing for 31.6% and 94.9% of participants, respectively.
- Trials frequently excluded pregnant/breastfeeding individuals, pediatric patients, and those with mild or severe HS, and imposed long placebo periods or washout requirements.
Conclusions:
- HS clinical trials exhibit significant barriers to participation and underrepresentation of key demographics, particularly Black individuals.
- Missing demographic data hinders understanding of trial generalizability and treatment equity.
- Future HS trials should adopt pragmatic designs, broaden inclusion criteria, and recruit from diverse communities to enhance participation and equity.
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 Central, and Web of Science databases was conducted. Peer-reviewed publications of randomized controlled trials that were written in English and had at least 10 participants were included. Title and abstract screening and data extraction were completed by two independent reviewers, with disagreements resolved by a third.
Results:
Twenty-three studies totaling 1,496 adult participants met the inclusion criteria. Race and ethnicity were not reported in 473/1,496 (31.6%) and 1,420/1,496 (94.9%) trial participants, respectively. Trial participants were predominantly white (811/1,023, 79.3%) and female (1,057/1,457, 72.5%). The median of each study's average age was 35.7 years (IQR 33.5-38.0), and 17/23 (73.9%) trials excluded pediatric patients. Nearly all participants had Hurley Stage II (499/958, 52.0%) or Hurley Stage III (385/958, 40.2%) disease. Many trials excluded patients who were pregnant (19/23, 82.6%) and breastfeeding (13/23, 56.5%), or who had HS that was "too severe" (8/23, 34.8%) or "too mild" (16/23, 70.0%). Frequently, trial protocols required prolonged washout periods from HS therapies, relatively long duration in the study's placebo arm, and prohibited concurrent analgesic use.
Conclusions:
This systematic review of 23 HS clinical trials totaling 1,496 participants identified substantial hardships imposed by trial participation, high rates of missing race and ethnicity data, and low representation of key patient groups, including those who identify as Black. Future trials with pragmatic study designs, broader inclusion criteria, and study sites in diverse communities may alleviate burdens of trial participation and improve enrollment of diverse patient groups.
More Related Videos
09:32Resolving Water, Proteins, and Lipids from In Vivo Confocal Raman Spectra of Stratum Corneum through a Chemometric Approach
Published on: September 26, 2019
06:28E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
Published on: August 1, 2019
Related Concept Videos
01:20Study Designs in Epidemiology
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and...
01:11Clinical Trials: Overview
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
01:16Clinical Trials
There are four phases in a clinical trial. A phase one...
01:15Study Design in Statistics
Does aspirin reduce the risk of heart attacks? Is one brand of fertilizer more effective at growing roses than another? Is fatigue as dangerous to a driver as the influence of alcohol? Questions like these are answered using randomized experiments with proper...
01:12Hazard Ratio
For example, in a clinical trial...