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Center for Global Research Data

A Systematic Review to Describe the Demographic Diversity of Dermatologic Clinical Trial Participants for Common Dermatologic Diseases

Lead Investigator: Junko Takeshita, University of Pennsylvania
Title of Proposal Research: A Systematic Review to Describe the Demographic Diversity of Dermatologic Clinical Trial Participants for Common Dermatologic Diseases
Vivli Data Request: 5086
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

The US population is rapidly diversifying, and according to the US Census Bureau’s 2014 National Projections report, more than half of the US population is projected to be represented by minority groups by 2044 (L.Colby & Ortman, 2015). Existing literature supports that responses to and adverse events due to drugs, including dermatologic drugs (Taylor, 2002), can differ between population subgroups (Conforti et al., 2018; Ramamoorthy, Pacanowski, Bull, & Zhang, 2015). NIH and FDA policies and guidelines call for adequate inclusion of women and minorities in clinical trials and other clinical research(National Institute of Health, 2001, 2017). However, despite federal efforts, emerging data suggest that clinical trials, including for dermatologic conditions, suffer from under-reporting of demographic data and under-representation of minorities (Charrow, Xia, Joyce, & Mostaghimi, 2017; Chen, Lara, Dang, Paterniti, & Kelly, 2014). There is limited literature on the diversity of clinical trials in dermatology, thus, additional and more detailed studies describing the current composition of dermatologic clinical trial populations are warranted.

Statistical Analysis Plan

Demographic data for the U.S. clinical trial participant pool is being requested through this proposal for clinical trials that were identified in our literature search and included multiple study sites outside of the U.S. The study hypothesizes that racial/ethnic minorities are under- represented in the clinical trials for psoriasis, atopic dermatitis and acne vulgaris in the US. The study will descriptively analyze the demographic factors specifically age, gender and race/ethnicity. Participants with missing data in these clinical trials will be included in the analysis and will be categorized as “not reported” in the descriptive summary. Final data includes descriptive summaries from each clinical trial obtained from different sources. Using the collective data, percentages will be calculated based on the absolute counts provided for each study. The total N will be calculated by summing the total enrolled numbers across the studies for each disease condition separately. To calculate the total number of participants enrolled in each race category (n), the number of participants enrolled in each race category will be summed, separately for each disease condition. The final weighted percentage for each disease condition and each demographic category will be conducted using the following formula,

Weighted percentage = (n/ N) x 100

The study results will be stratified by disease: psoriasis, atopic dermatitis, and acne and, by the study year. The data analysis will be conducted using STATA 15.

Per our study protocol, the purpose of this study is to provide a descriptive summary of the age, sex, and racial/ethnic distribution of U.S. participants in clinical trials for psoriasis, atopic dermatitis, and acne between Jan 1st 2014 and 3rd July 2019. As such, there is no direct comparison group. While we will make indirect comparisons to the U.S. population distribution of the aforementioned characteristics during the study period, this comparison will be qualitative in nature without the use of statistical tests. These indirect comparisons will be made to the U.S. population based on census data which are accepted to be generalizable.

Also, the study will not numerically adjust for the differences in disease prevalence by race/ethnicity. However, indirect references to the racial/ethnic composition of clinical trials by dermatologic condition (the study primary outcome) to what is known about the prevalence of each disease by race/ethnicity will be made to provide context.

Requested Studies:

A 12-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate to Severe Plaque Psoriasis With a Long-Term Extension Period (UNCOVER-3)
Sponsor: Eli Lilly and Co.
Study ID: NCT01646177
Sponsor ID: 13685

A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Versus Placebo in Patients With Moderate-to-Severe Genital Psoriasis (IXORA-Q)
Sponsor: Eli Lilly and Co.
Study ID: NCT02718898
Sponsor ID: 16010

A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Dosing Regimens in Patients With Moderate-to-Severe Plaque Psoriasis (IXORA-P)
Sponsor: Eli Lilly and Co.
Study ID: NCT02513550
Sponsor ID: 15988

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate-to-Severe Plaque Psoriasis (UNCOVER-2)
Sponsor: Eli Lilly and Co.
Study ID: NCT01597245
Sponsor ID: 12973

A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period and a Long- Term Extension Period to Evaluate the Efficacy and Safety of LY2439821 in Patients With Moderate-to-Severe Plaque Psoriasis (UNCOVER-1)
Sponsor: Eli Lilly and Co.
Study ID: NCT01474512
Sponsor ID: 12972

BI 655066/ABBV-066 (Risankizumab) Versus Adalimumab in a Randomized, Double Blind, Parallel Group Trial in Moderate to Severe Plaque Psoriasis to Assess Safety and Efficacy After 16 Weeks of Treatment and After Inadequate Adalimumab Treatment Response (IMMvent)
Sponsor: Abbvie
Study ID: NCT02694523
Sponsor ID: M16-010

BI 655066/ABBV-066 (Risankizumab) Versus Ustekinumab and Placebo Comparators in a Randomized Double Blind trIal for Maintenance Use in Moderate to Severe Plaque Type Psoriasis (UltIMMa-1)
Sponsor: Abbvie
Study ID: NCT02684370
Sponsor ID: M16-008

BI 655066 Versus Ustekinumab and Placebo Comparators in a Randomized Double Blind trIal for Maintenance Use in Moderate to Severe Plaque Type Psoriasis-2 (UltIMMa-2)
Sponsor: Abbvie
Study ID: NCT02684357
Sponsor ID: M15-995

A Phase 3, Multicenter, Double-Blind, Randomized, Parallel-Arm, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Adalimumab for Treatment of Nail Psoriasis in Patients With Chronic Plaque Psoriasis
Sponsor: Abbvie
Study ID: NCT02016482
Sponsor ID: M13-674

Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial
Sponsor: Regeneron
Study ID: NCT02260986

Two Phase 3 Trials of dupilumab versus placebo in atopic dermatitis
Sponsor: Regeneron
Study ID: NCT02277743

Two Phase 3 Trials of dupilumab versus placebo in atopic dermatitis
Sponsor: Regeneron
Study ID: NCT02277769

Public Disclosure:

560 Racial/ethnic diversity in U.S. clinical trials for acne, atopic dermatitis, and psoriasis
Sevagamoorthy, A. et al.
Journal of Investigative Dermatology, Volume 141, Issue 5, S97
DOI: https://doi.org/10.1016/j.jid.2021.02.587