Dear PALISI Investigators,
Please review the important updates and announcements in the digest below.
Inside this issue:
Membership Dues
Clinical Research Course
CRC Spring 2024 Speakers Survey
PALISI Platform Trials
PALISI 2024 Spring Meeting
Communications Update
Membership Dues
Paid membership is required to participate in PALISI Network activities. Attendees at PALISI meetings who have not paid their annual (i.e., AY 2024: July 2023 – June 2024) dues will be given the opportunity to submit dues payment on site by credit card.
The PALISI Network relies on your membership dues to sustain its operations, and your prompt dues payment is vital to our continued functioning. Monae Dove has issued email notifications to all sites and members who have yet to initiate the dues process or have outstanding invoices. We urge you to promptly follow the instructions provided in the email to bring your site up to date. Additionally, we kindly ask that you verify your current membership status, ensuring sufficient attendances are remaining after the fall meeting to accommodate all individuals planning to attend the upcoming spring meeting. Should you have any inquiries regarding your membership status or require assistance with remitting payment, please make use of the resources available at www.palisi.org/join-renew-membership or feel free to contact us via email at admin@palisi.org. Your timely cooperation is greatly appreciated, and we thank you for your ongoing support in keeping PALISI Network operational.
Clinical Research Course
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
CRC Spring 2024 Speakers Survey
We are working on putting together PALISI's Clinical Research Course (CRC) for the Spring 2024 conference and we need your help! We are looking for PALISI members with experience to share with the next generation of researchers. If this is you, we would love for you to participate as a lecturer, panelist, or facilitator for the course.
In the past, we have directly reached out to people to solicit their help and we have had wonderful and compelling sessions. If you have been one of the past speakers, thank you - we sincerely hope you are willing to participate again. This year we are doing a hybrid approach, so in addition and to open up the opportunity to more of the PALISI community, we have decided to reach out more broadly.
If you are interested, please complete the survey link included below. Each of the sessions includes a tentative time to help with planning. We will do our best to accommodate folks as we are able depending on interest. Please complete the survey by January 11th.
Again, we so appreciate all of you and hope you will consider helping out with the course.
Thanks,
Alison Nair and Tina Cifra
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)
Get Ready for the PALISI Spring Meeting!
Get Ready for our Spring Meeting in San Juan, Puerto Rico! The Clinical Research Course and a few subgroup meetings will be held on Wed 2/28. The main meeting will be Thurs 2/29 and ending midday Sat 3/2. Please register and reserve your hotel room on our website https://www.palisi.org/springmeeting24. Be sure to use our group code PLSI24 as per the instructions to get our discounted room rate.
Communicating with the PALISI Team
Don’t forget to follow us on X/(formerly Twitter) @PALISINet
Do 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!