www.biopharminternational.com March 2021 eBook BioPharm International 31
Extrapolating Data from Adult
Clinical Trials to Advance Pediatric
Drug Development
Adult clinical trial data can be used to support the dose selection
and regimen—or waive the need for a placebo control arm
—for pediatric studies.
E
xtrapolation to the pediatric population using
available data obtained from a reference
population is a well-recognized approach to
achieve more efficient pediatric drug devel-
opment and avoid unnecessary pediatric clin-
ical trials. While regulations regarding the use of
extrapolation date back to 1994 (1), there are still sig-
nificant challenges in the implementation of pediatric
extrapolation (2–4). To ensure the "voice of industry"
was heard as the regulatory landscape evolved, the
Clinical Pharmacology Leader Group (CPLG) of the IQ
Consortium (IQ) established the Pediatric Working Group
(PWG) in 2011, and it has evolved to be an integral part
of the implementation and dissemination of the use of
extrapolation as a framework to optimize the develop-
ment of therapeutics for pediatric use.
The PWG currently consists of 38 members from 24
different organizations, and includes representatives
from IQ corporate members, regulatory agencies, and
non-IQ member companies to strengthen its diversity
in expertise and perspective on pediatric drug devel-
opment. In collaboration with the pharmaceutical
industry, regulatory agencies, academia, and non-profit
organizations, the PWG has organized/co-organized
Paulista
-
Stock.adobe.com
Sebastian Haertter, S.Y. Amy Cheung, Angela James, Ashley Strougo, Christina
Bucci-Rechtweg, Jing Liu, Meina Tao Tang, Paulien Ravenstijn, Raafat Bishai,
Satyendra Suryawanshi, and Solange Corriol-Rohou; all authors are members
of the IQ Consortium.
Regulatory Sourcebook Quality Collaboration