ETAC Informational Webinar: Proposed Electronic Logging Device Rule
ETAC November Kick-Off Meeting...ETAC Expectations/Roles •Cross training to expose all members and...
Transcript of ETAC November Kick-Off Meeting...ETAC Expectations/Roles •Cross training to expose all members and...
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