Pediatric Drug Development

Subgroup

Projects

Workproducts/Timeline

 

1. AdHoc Projects

(Drop-down)

1.      Youth Onset T2DM Workshop

Steering Committee Membership

2.      DPMH Workshop on Advancing the Development for Pediatric Therapeutics

Steering Committee Membership

2.      Extrapolation

(Drop-down)

Review of literature on Extrapolation

1.      Presentation

2.      Paper

3.      Innovative Design

(Drop-down)

Review of literature on Extrapolation

1.      Presentation

2.      Paper

4.      Special Projects

(Drop-down)

Conference Sessions

1.      JSM/RISW proposals submitted

2.      Short course

3.      Proposals for other conferences

Webpage and Informational slide deck

1.      Webpage Content

2.      Logo for the SWG

3.      Informational slides:

a.      Statistics in Pediatric Drug Development Working Group)

b.      Primer on Pediatric Drug Development

c.      Primer/Survey on Complex Innovative Design and Extrapolation

d.      Survey on Inclusion of Adolescents in Adult Research

e.      Horizon landscape of related organizations and contacts

Short Communications Project

1.      Statistics in Pediatric Drug Development Workgroup – Biopharmaceutical Report

2.      Three decades of pediatric drug development – Clinical Trials

3.      Juvenile Idiopathic Arthritis and how statistics made an impact on endpoint collection

4.      Neonates and maternal health – HIV and the Anti-retroviral Pregnancy Registry

5.      Impact Stories

Pediatric safety exposures and assessments

Survey and paper on Pediatric safety exposures and assessments

Survey of pediatric interest areas and information repository

1.      Survey of Methodologies of interest

2.      Information repository of trials and other useful pediatric information

Landscape Scanning of other Pediatric Interest Groups

Information list and contacts