FDA-M CERSI: Analgesic Clinical Trial Designs, Extrapolation, and Endpoints in Patients from Birth to Less Than Two Years of Age Public Workshop
October 13 - 14, 2021
- October 13 - 14, 2021
- Wed, Oct 13
- Thu, Oct 14
FDA’s Division of Pediatrics and Maternal Health (DPMH) in collaboration with the Division of Anesthesiology, Addition Medicine, and Pain Medicine (DAAP) and the University of Maryland CERSI, are announcing a 2-day public workshop, “Analgesic Clinical Trial Designs, Extrapolation, and Endpoints in Patients from Birth to Less Than Two Years of Age”. The purpose of the public workshop is to discuss the current state of therapies to treat acute pain in children, identify data gaps, and consider methods to improve the current drug development paradigm for acute pain in patients less than 2 years of age (e.g., use of pediatric extrapolation, and novel clinical trial designs). The workshop is intended to focus on drugs with well-established mechanisms of action (NSAIDs, acetaminophen, local anesthetics, opioids), rather than drugs with novel mechanisms of action.
The public workshop will be held on:
Date: October 13 and 14, 2021
The public workshop will be held in virtual format only. Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this public meeting via an online teleconferencing platform.
Invite Link: https://collaboration.fda.gov/rnrrqh9l5cgz
Registrants will receive webcast information once registered.
Agenda and Registration:
To access the agenda and registration for the public workshop, visit the following website: https://cersi.umd.edu/event/16557/analgesic-clinical-trial-designs-extrapolation-and-endpoints-in-patients-from-birth-to-under-age-2.
There is no registration fee to attend this public workshop.
Day 1 slides
- Beth Durmowicz, MD. Ethical and Scientific Considerations for the Use of Pediatric Extrapolation
- Suellen Walker, PhD. Development of nociception and pain
- Ricardo Carbajal, MD. Pain epidemiology in neonates and infant patients
- Chris Mcpherson, PharmD. Developmental pharmacology of analgesics
- John van den Anker, MD. Extrapolation of adult efficacy data to pediatric patients
Day 2 slides
- Carolina Donado-Rincon, MD., Joe Kossowsky, PhD., Charles Berde, MD. Trial Design Considerations for Acute Pain in neonates and infants: Academic Perspective
- Edress Darsey, PharmD. Trial Design Considerations for Acute Pain in neonates and infants: Industry Perspective
- Lisa Wiltrout, MD. Trial Design Considerations for Acute Pain in neonates and infants: Regulatory Perspective
- Monique van Dijk, Outcome measures in acute pain clinical trials in neonatal & infant populations
- Kanecia Zimmerman, MD, MPH. PTN COA development and PTN/NICHD trials for off patent drugs
- Rebeccah Slater, PhD Brain-derived approaches to assess neonatal & infant pain
- Brian Anderson, MB ChB, PhD, FANZCA, FCICM. Innovative trial designs including Bayesian approaches
- Amy Cheung, PhD Considerations for PK/PD studies