Organizational news:
Background, successes and areas of focus can be found in the organization’s Annual & Update Reports.
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.
Advocacy
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 clincian-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.
PeDRA is a major sponsor of the FDA Guidance Document for Industry (GDI), which contain guidelines on developing new therapeutic agents for treatment of atopic dermatitis in children and adolescents. March 2016 GDI Update.
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.
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
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
