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Alternative Data Presentation For Treatment Outcomes in Psoriasis
Proposal
5951
Title of Proposed Research
Alternative Data Presentation For Treatment Outcomes in Psoriasis
Lead Researcher
Robert Gniadeki
Affiliation
University of Alberta, Faculty of Medicine & Dentistry, Division of Dermatology, Canada
Funding Source
Potential Conflicts of Interest
Data Sharing Agreement Date
Lay Summary
Modern patient care is built upon evidence-based medicine and relies on clinical trial data. However, traditional outcomes such as proportions of patients achieving a primary outcome lack clinical relevance for physicians. This project will investigate the usage of alternative methods of data analysis and presentation focusing on capturing individual patient outcomes, such as: waterfall plots and spider plots. We will also explore n-of-1 level analyses in psoriasis biologic clinical trials to further describe individualistic therapy outcomes and explore the possibility of designing smaller and more cost-efficient studies. We hypothesize these methods will provide more clinically relevant information and facilitate psoriasis treatment decisions for clinicians.
Study Data Provided
[{ "PostingID": 4450, "Title": "LILLY-I1F-MC-RHBL", "Description": "Pharmacokinetic Evaluations of Ixekizumab Following Subcutaneous Administration Using Prefilled Syringe or Auto-Injector in Patients With Moderate-to-Severe Plaque Psoriasis UNCOVER-A" },{ "PostingID": 4451, "Title": "LILLY-I1F-MC-RHAJ", "Description": "A Dose-Ranging And Efficacy Study of LY2439821 (An Anti-IL-17 Antibody) In Patients With Moderate-To-Severe Psoriasis" },{ "PostingID": 4452, "Title": "LILLY-I1F-MC-RHAZ", "Description": "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" },{ "PostingID": 4453, "Title": "LILLY-I1F-MC-RHBA", "Description": "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" },{ "PostingID": 4454, "Title": "LILLY-I1F-MC-RHBC", "Description": "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" },{ "PostingID": 5059, "Title": "LILLY-I1F-MC-RHBS", "Description": "A 52-Week Multicenter, Randomized, Blinded, Parallel-Group Study Comparing the Efficacy and Safety of Ixekizumab to Ustekinumab in Patients With Moderate-to-Severe Plaque Psoriasis (IXORA-S)" },{ "PostingID": 16102, "Title": "LILLY-I1F-MC-RHBE", "Description": "Safety and efficacy of ixekizumab in patients with PsA and previous inadequate response to TNF inhibitors: week 52 results from SPIRIT-P2." },{ "PostingID": 16125, "Title": "LILLY-I1F-MC-RHAP", "Description": "A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients With Active Psoriatic Arthritis (SPIRIT-P1)" },{ "PostingID": 16126, "Title": "LILLY-I1F-JE-RHAT", "Description": "A Multicenter, Open-Label, Long-Term Study to Evaluate the Efficacy and Safety of LY2439821 in Japanese Patients With Moderate-to-Severe Psoriasis (UNCOVER-J)" },{ "PostingID": 16127, "Title": "LILLY-I1F-MC-RHBP", "Description": "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)" },{ "PostingID": 19616, "Title": "LILLY-I1F-MC-RHBQ", "Description": "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)" }]
Statistical Analysis Plan
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