ETAC November Kick-Off Meeting November 18, 2019

Clinical Outcome Assessments for Acute Pain Therapeutics in Infants and young Children

I. Research team and ETAC introductions

II. Overview goals/scope

III. ETAC expectations/roles

IV. Upcoming ETAC face-to-face meeting (Feb/March 2020 in Durham, NC)

V. Discuss face-to-face future meeting dates and other next steps

Meeting Agenda

Refer to corresponding ETAC booklet for members’ expertise and perspective

Research Team and ETAC Introductions

o Pain among infants and young children is disproportionately under-recognized and undertreated

o We must identify or develop drugs that provide safe and effective pain management in infants and young children

o This process relies on the existence of high-quality clinical outcome assessments (COAs) and standardized, well-justified endpoints

o To date, no well-accepted core set of COAs exists for use in infants and young children with acute pain.

Clinical Outcome Assessments for Acute Pain Therapeutics in Infants and young Children

○ CEDR Pilot Grant Program: Standard Core Clinical Outcome Assessments(COA) and their Related Endpoints

○ Relevance of COA-APTIC for pediatric clinical trials

Robyn BentUS FDA

CEDR Pilot Grant Program

COA-APTIC: Overview and Milestones

COA-APTIC: Overview and Milestones

1. List outcomes important to stakeholders in the context of pediatric acute pain

2. ETAC cross training from major stakeholder groups

COA-APTIC: Overview and Milestones

1. List of existing COAs for each outcome 2. Evaluation of quality for each COA 3. Final protocols for UH3 phase approved by ETAC

COA-APTIC: Overview and Milestones

1. Standard set of core COAs and endpoints appropriate for use in pediatric acute pain trials

2. Documentation and user manuals for all COAs and endpoints

• Attend teleconferences and face to face meetings each year during the UG3 and UH3 phases.

• Perform cross-training of other ETAC and COA-APTIC members

• Provide input on all key decisionso Provide feedback on approach, findings, and

recommendations for each milestone

ETAC Expectations/Roles

• Cross training to expose all members and research team to different stakeholder perspectives, skills, experiences, and methods

• Additional agenda items –Summary of preliminary literature review–Plans for stakeholder interviews

Upcoming ETAC Face-to-Face Meeting

Discuss Face-to-Face Future Meeting Dates and Other Next Steps