Dear PALISI Investigators,
Please read the important spring meeting updates and other announcements below.
DRAFT Spring Meeting Agenda
Spring Meeting Registration Process Reminder
Clinical Research Course
Additional Positions of Interest at the NIH
PALISI Platform Trial
General PALISI Communication Reminders
PALISI Network
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DRAFT Spring Meeting Agenda
As per your feedback and the goals of the PALISI Executive Committee, we are sharing the draft agenda for our spring meeting in San Juan, Puerto Rico, and online. Based on member feedback, we are trialing some different daytime schedules. We have scheduled subgroups per the recommendations of the subgroup leaders to minimize conflicts. We look forward to your feedback. Please send any feedback to Heidi Flori heidiflo@med.umich.edu, and copy Neethi Pinto on any subgroup PINTONP@chop.edu.
Spring Meeting Registration Process Reminder
As you prepare the for meeting, a reminder that you are NOT fully registered and able to attend the meeting unless you have a ticket in hand, such as the attached ticket. You/your organization must be up to date in your membership dues to receive a ticket and attend. In addition, please reserve your hotel room(s) ASAP if not already done. Meeting information can be found at https://www.palisi.org/springmeeting24
Clinical Research Course- Register Today!
Are you a junior investigator interested in developing your research skills from leading scientists in the field of pediatric critical care? Join us for PALISI’s Clinical Research Course on February 28, 2024 from 8am-5pm. This one-day intensive workshop is designed to expose junior investigators to key components of a research career and develop connections in the PALISI community. Topics will include developing your research career, cultivating mentorship and collaborations, strategies for your professional success, and more!
Register at: www.palisi.org/clinicalresearchcourse
Questions? Contact: Alison.Nair@ucsf.edu
Additional Positions of Interest at the NIH
Please see additional positions and notices of interest to this group from the NIH in the attachment. Contact information is included in the announcement.
PALISI Platform Trial
Over the past several months the PALISI Platform Trial Steering Group (PTSG) has continued to meet and has reached consensus on several critical points that we wanted to share with you. We are writing to you today to solicit candidate initial Phase 3 trials that are ready to accompany our funding proposal.
Our purpose is to build a single integrated adaptive platform trial (APT) to efficiently evaluate multiple therapies, individually or in combination, focused on critically ill children in the pediatric intensive care unit. An APT allows for the concurrent evaluation of multiple groups of mutually exclusive treatments (referred to as “Domains”; e.g., high vs low target glucose control or high vs low PEEP) across several different therapeutic clusters (e.g., immune/endocrine modulation, respiratory support). We intend to enroll PICU patients and randomly assign each to a single treatment regimen that includes a combination of one or several treatment domains.
Our inclusion criteria will potentially include children admitted to the PICU for either primary or secondary cardiovascular or respiratory dysfunction (i.e., heart or lung failure; cardiac dysfunction would include children supported on inotropes or vasopressors, ECMO/VAD; respiratory dysfunction would include children supported on HHFNC, NIV, IMV, ECMO).
Our Primary Outcome variable (inferential whole) is ICU-free days.
Our Secondary Outcomes will include Mortality, MODS, plus Domain-Specific outcomes.
We have also outlined an organizational structure that will include a large interprofessional Steering Committee and several Cores.
At this time, we would like to identify interventions that YOU think are ready for a Phase 3 RCT that could become integrated into the APT as described above, including the intended patient population, and delineated outcomes.
If you or your group has an idea, we ask that you please provide a one-page outline including the following points. (Note that we are not looking for a Specific Aims page.)
Draft Title
Lead Investigator(s): Name(s) and contact information
PALISI subgroup: Has the study been vetted in a PALISI subgroup?
Therapeutic cluster: e.g., Immune/endocrine modulation, Respiratory support,
Transfusions, ECMO, other Critical Care therapies
Brief overview of the compelling rationale for the proposed study
Importance of the research (Significance)
Preliminary data supporting a Phase 3 trial
Domain – what intervention arms will be compared?
Treatment arms
Inclusion/exclusion criteria (major)
Timing of randomization (if important)
To make sure that we are conducting important Phase 3 trials on the platform, we will curate the submitted ideas and vet study prioritization with the PALISI membership before/during the Spring meeting. Note that the lead investigator(s) submitting the study idea, if it is prioritized, will become a member of the steering committee. Finally, this is intended as the starting point. We are seeking near-ready Phase III proposals to maximize our chances with funding opportunities. If this first phase is successful, then the PLATFORM will be expanded to accommodate earlier phase studies (i.e. Phase I/II) and potentially more therapeutic clusters and more domains. If you have any questions or concerns or other suggestions, please reach out to any member of the PTSG. Please send your outline to Lou Ventura at VENTURAL@chop.edu by January 31, 2024. If that timing doesn’t work for you, please drop us a note with a timeframe that would work.
Our best,
Martha A.Q. Curley (Curley@UPENN.edu)
Michael Agus (Michael.Agus@childrens.harvard.edu)
Roby Khemani (RKhemani@chla.usc.edu)
Tell Bennett (TELL.BENNETT@CUANSCHUTZ.EDU)
David Wypij (David.Wypij@cardio.chboston.org)
Roger J. Lewis (roger@berryconsultants.net)
General PALISI Communication Reminders
Don’t forget to follow us on X/(formerly Twitter) @PALISINetDo you have any information that you would like to share in the monthly digest? Make sure to submit it to Ann-Marie Brown by the 1st day of the month at www.palisi.com/communications. (Direct Email: ann-marie.brown@emory.edu). This is also the place for questions for the Executive Committee or administrative team anytime!