Clinical Trial Diversity for Common Dermatologic Diseases: A Systematic Review

Clinical Trial Diversity for Common Dermatologic Diseases: A Systematic Review

Background: Existing literature supports that responses to drugs and therapeutics differ between population subgroups. Emerging data suggest that clinical trials suffer from under-reporting of demographic data and under-representation of minorities. Literature on diversity of dermatologic clinical trials is limited, warranting further research. Objective: The study aims to describe the demographic composition of dermatologic clinical trial participants in the U.S. for psoriasis, atopic dermatitis and acne vulgaris reported between 2014 and 2019. Study design: A systematic review of literature on psoriasis, atopic dermatitis and acne vulgaris phase 3 clinical trials published between 2014 and 2019. Data will be compiled from two sources−for studies conducted exclusively in the US, demographic data reported in the published articles and among international studies, descriptive analysis and summary for each clinical trial requested from study sponsors. Final data includes descriptive summaries from each clinical trial obtained from different sources. Participants: Dermatologic clinical trial participants, specifically from psoriasis, atopic dermatitis and acne vulgaris trials reported between 2014 and 2019 and enrolled in the US. Main outcomes: Participant enrollment in the US measured by mean/median age of the participant pool and proportion by sex and race/ethnicity. Statistical Analysis: Collective data will be weighted for the total population across the clinical trials and descriptive data analysis using weighted study population will be conducted.

[{ "PostingID": 3956, "Title": "NOVARTIS-CAIN457A2302", "Description": "A Randomized, Double-blind, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis" },{ "PostingID": 3957, "Title": "NOVARTIS-CAIN457A2303", "Description": "A Randomized, Double-blind, Double-dummy, Placebo Controlled, Multicenter Study of Subcutaneous Secukinumab to Demonstrate Efficacy After Twelve Weeks of Treatment, Compared to Placebo and Etanercept, and to Assess the Safety, Tolerability and Long-term Efficacy up to One Year in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis" },{ "PostingID": 4068, "Title": "NOVARTIS-CAIN457A2304", "Description": "A randomized, double-blind, multicenter study of subcutaneous secukinumab, assessing Psoriasis Area and Severity Index (PASI) response and maintenance of response in subjects with moderate to severe chronic plaque-type psoriasis on either a fixed dose regimen or on a retreatment at start of relapse regimen Study Comparing secukinumab Use in Long-term Psoriasis maintenance therapy: fixed regimens vs reTreatment Upon start of RElapse (SCULPTURE" },{ "PostingID": 4069, "Title": "NOVARTIS-CAIN457A2307", "Description": "A randomized, double-blind, double dummy, multicenter study to assess the safety, tolerability and long-term efficacy of intravenous (10 mg/kg) and subcutaneous (300 mg) secukinumab in patients with moderate to severe chronic plaque-type psoriasis who are partial responders to secukinumab Secukinumab Trial Analyzing the potential of intravenous administration To Upgrade the REsponse in psoriasis (STATURE)" },{ "PostingID": 4070, "Title": "NOVARTIS-CAIN457A2308", "Description": "A randomized, double-blind, placebo controlled, multicenter study of subcutaneous secukinumab in prefilled syringes to demonstrate efficacy after twelve weeks of treatment, and to assess the safety, tolerability, usability and long-term efficacy in subjects with chronic plaque-type psoriasis" },{ "PostingID": 4071, "Title": "NOVARTIS-CAIN457A2309", "Description": "A randomized, double-blind, placebo controlled, multicenter study of subcutaneous secukinumab in autoinjectors to demonstrate efficacy after twelve weeks of treatment, and to assess the safety, tolerability, usability and long-term efficacy in subjects with chronic plaque-type psoriasis" },{ "PostingID": 20264, "Title": "NOVARTIS-CAIN457A2317", "Description": "A 52-week, multicenter, randomized, double-blind study of subcutaneous secukinumab to demonstrate efficacy as assessed by Psoriasis Area and Severity Index at 16 weeks of treatment compared to ustekinumab and to assess long-term safety, tolerability and efficacy in subjects with moderate to severe plaque psoriasis (CLEAR)" },{ "PostingID": 20265, "Title": "NOVARTIS-CAIN457A2326", "Description": "A 52-week, randomized, double-blind study of secukinumab (300 mg) compared to ustekinumab in subjects with moderate to severe plaque psoriasis" },{ "PostingID": 20266, "Title": "NOVARTIS-CAIN457A2312", "Description": "A randomized, double-blind, placebo-controlled, multicenter study to demonstrate the efficacy at 16 weeks of secukinumab 150 and 300 mg s.c. and to assess safety, tolerability and long-term efficacy up to 132 weeks in subjects with moderate to severe palmoplantar psoriasis" },{ "PostingID": 20267, "Title": "NOVARTIS-CAIN457A2313", "Description": "A randomized, double-blind, placebo-controlled, multicenter, study to demonstrate the efficacy at 16 weeks of secukinumab 150 and 300 mg s.c. and to assess safety, tolerability and long-term efficacy up to 132 weeks in subjects with moderate to severe nail psoriasis" }]