PeDRA News

Organizational News:

Background, successes and areas of focus can be found in the organization’s Annual and Update Reports.

2017 Annual Report

Report of PeDRA 2016  Activities

2016 Update Report

2013-2014 Report

PeDRA  published the PeDRA Post, PeDRA’s twice yearly e-newsletter, which tracks progress being made with studies, highlights patient advocacy organizations engaged with PeDRA, and profiles special donors. PeDRA also offers educational opportunities for investigators.

Summer 2018 News


PeDRA Published Studies

> View Studies

Title: Pediatric Psoriasis Comorbidity Screening Guideline
Citation: JAMA Dermatology; Published online May 17, 2017; 10.1001/jamadermatol.2017.0499
Link to Publication

Title: Pediatric Skin Cancer: Patient Perspectives
Citation: Pediatric Dermatology; 2017; 34(2):187-188; 10.1111/pde.13135
Link to Publication

Title: Safety of Systemic Agents for the Treatment of Pediatric Psoriasis
Author: Inge M. G. J. Bronckers, MD
Citation: JAMA Dermatology; 2017;153(11):1147-1157; 10.1001/jamadermatol.2017.3029
Link to Publication

Title: First Guideline on Pediatric Psoriasis Comorbidity Screening
Author: News Author: Veronica Hackethal, MD; CME Author: Laurie Barclay, MD
Link to Publication

Title: Prescribing practices for systemic agents in the treatment of severe pediatric atopic dermatitis in the US and Canada: The PeDRA TREAT survey
Authors: Totri CR, Eichenfield LF, Logan K, Proudfoot L, Schmitt J, Lara-Corrales I, Sugarman J, Tom W, Siegfried E, Cordoro K, Paller AS, Flohr C.
Citation: J Am Acad Dermatol; 2017;76(2):281-285; 10.1016/j.jaad.2016.09.021
Link to Publication


Advocacy

> PeDRA Position Papers

PeDRA advocates for better access to treatments for children with dermatology diseases. Read PeDRA’s position statement submitted to the FDA on patient-focused drug development for alopecia areata: PeDRA position on alopecia areata drug development and the National Alopecia Areata Foundation’s statement: NAAF position on alopecia areata drug development

PeDRA advocates for better access to treatments for children with dermatology diseases. Read PeDRA’s position statement submitted to the FDA on patient-focused drug development for psoriasis: PeDRA position on psoriasis drug development.

The FDA has announced publication of the Psoriasis Voice of the Patient report that summarizes patient input from the March 17, 2016 FDA Patient-Focused Drug Development meeting on psoriasis. PeDRA clinician-investigators made comments at the meeting, as did a PeDRA pediatric patient, and provided the psoriasis position statement referenced above. The FDA report can be found here: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm368342.htm.

In 2015, PeDRA testified at an FDA hearing on developing atopic dermatitis systemic treatments for children. In addition to testifying, PeDRA developed a position statement, endorsed by several organizations, supporting the inclusion of children in appropriate clinical trials for these treatments. Read the position statement here.

In 2015, PeDRA provided leadership with the NIH on the question of advantages in using a central IRB for multisite studies. The PeDRA position outlined how a central IRB can eliminate redundant work efforts, streamline research and encourage collaborative work. Read PeDRA’s position statement here

PeDRA Guidance Documents
PeDRA is a major sponsor of the FDA Guidance Document for Industry (GDI), which contains guidelines on developing new therapeutic agents for treatment of atopic dermatitis in children and adolescents. Read the Guidance Document submitted to the FDA GDI submitted
> Policy Developments
The Pediatric Research Equity Act (PREA), passed in 2003, is a program that authorizes the FDA to require the study of a new drug or biologic in pediatric populations. PREA has the potential to provide pediatric labeling data as new products enter the market, thus helping to prevent non evidence-based use of new therapeutics in children. Read how updates to PREA can generate the evidence needed for pediatric drug development: The Pediatric Research Equity Act Moves Into Adolescence
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