My name is Tonse Raju. I'm a Program Officer
in the Environmental influences on Child Health Outcomes office, managing the IDeA States
Pediatric Clinical Trials Network, or ISPCTN. Thank you for your interest in this new funding
opportunity titled, “Clinical Sites for the Environmental influences on Child Health
Outcomes IDeA States Pediatric Clinical Trials Network, third Cycle”.
The purpose of this webinar is to provide potential applicants with an overview of the
ECHO Program and ECHO IDeA St
ates Pediatric Clinical Trials Network.
I intend to provide an orientation to this funding opportunity announcement and answer
some frequently asked questions. In 2016, NIH launched a nationwide program
called the ECHO Program. The mission of the ECHO Program is to enhance
the health of children for generations to come.
The ECHO Program research on child health and development focuses on five key pediatric
outcome areas that have high public health impact.
These areas are pre-, peri-, and postna
tal health; upper and lower airway conditions;
obesity; neurodevelopment; and positive health. In 1993, following a Congressional mandate,
the NIH implemented IDeA programs with a goal to broaden the geographic distribution of
NIH funding. These programs support faculty development
and institutional research infrastructure enhancement in IDeA states that have historically
received low levels of support from NIH. In addition, the programs serve the unique
populations in the IDeA States, which are
predominantly rural or underserved.
The 23 states and the Commonwealth of Puerto Rico are named as Institutional Developmental
Award eligible States and they are shown in this slide.
I’m going to read the names of these 23 states and Puerto Rico in alphabetical order:
Alaska, Arkansas, Delaware, Hawaii, Idaho, Kansas, Kentucky, Louisiana, Maine, Mississippi,
Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma, Puerto
Rico, Rhode Island, South Carolina, South Dakota, Ver
mont, West Virginia, and Wyoming.
In 2016, NIH established the ECHO IDeA States Pediatric Clinical Trials Network.
The overall goals of the network are to provide children from rural or underserved populations
access to state-of-the-art clinical trials, to build pediatric research capacity within
the IDeA States to conduct these trials. Additional goals include engaging communities
and interested parties in ECHO ISPCTN research processes; and enhance diversity, equity,
inclusion, and accessibili
ty in workforce and participants.
In this slide, I'm showing the NIH ECHO Program that has two main Components.
On your left side is the ECHO Cohort Consortium, and on your right side is the IDeA States
Pediatric Clinical Trials Network, or ISPCTN. The ISPCTN is the intervention arm of the
ECHO Program and it is the focus of this presentation. In addition, specific goals through the first
two cycles of ISPCTN are listed on this slide. ISPCTN overall goals from the first cycle,
that is from 2016
through 2020, were to allow children from rural or underserved populations
access to state-of-the-art clinical trials, and to build pediatric research capacity in
the ECHO ISPCTN-funded IDeA States. In the second cycle, we added engaging communities
and interested parties in ISPCTN research processes, and we also required one to two
Junior Investigators. Additional crosscutting goals added in Cycle
2 include: to enhance diversity, equity, inclusion, and accessibility in the workforce and researc
h
participation. In section one of the RFA you will find a
high-level description of this funding opportunity. This RFA invites applications from entities
and institutions in the IDeA States to participate as Clinical Sites in the ECHO ISPCTN.
The announcement runs in parallel with the companion RFA-OD-24-009, soliciting applications
for a Data Coordinating and Operations Center (DCOC) within the IDeA States.
The Clinical Sites and DCOC together will form the ECHO ISCPTN.
The Clinical Sites of t
he ECHO ISPCTN are required to develop, conduct, and disseminate
findings from pediatric multicenter clinical trials, assuring the participation of children
living in rural or underserved communities located in the IDeA States; it is also required
to build pediatric clinical trial network capacity in the IDeA States funded by the
ECHO ISPCTN; and to engage interested parties such as community members, nonprofit organizations,
and professional societies to enhance ECHO ISPCTN clinical trial impac
t, transferability,
rigor, and feasibility. This award will support approximately five
pediatric clinical trials related to the prevention or treatment of conditions in at least two
of the five outcome areas mentioned earlier, namely: pre-, peri-, and postnatal outcomes;
obesity; upper and lower airway conditions; neurodevelopment; and positive health.
This actually means that a single topic cannot be the focus of research in more than three
trials. Therefore, among the five clinical trials, at
least two topics will be represented.
NIH intends to fund an estimated 15 to 20 awards corresponding to a total of $7 million
dollars for fiscal year 2025. Future year amounts will depend upon the annual
appropriations, and the number of awards also is contingent upon the NIH appropriations
and the submission of a sufficient number of meritorious applications.
Award budget: Applicants may request a direct cost of up to $300,000 for each of the five
years of the award. The application should incl
ude a detailed
budget for each of the study years that are being proposed.
The award project duration is five years. Eligibility information for the institutions
that can apply include institutions of higher education, nonprofit entities other than the
institutions of higher education, for-profit organizations, local governments, and, of
course, the federal government. Only the institutions located in the 23 IDeA
States and Puerto Rico are eligible to apply as the lead applicant organizations in
response
to this RFA. I am going to read the names of these 23 states and Puerto Rico in an alphabetical order: Alaska, Arkansas, Delaware, Hawaii, Idaho,
Kansas, Kentucky, Louisiana, Maine, Mississippi, Montana, Nebraska, Nevada, New Hampshire,
New Mexico, North Dakota, Oklahoma, Puerto Rico, Rhode Island, South Carolina, South
Dakota, Vermont, West Virginia, and Wyoming. The Program Director or Principal Investigator
from an IDeA State should have skills, knowledge, and resources necessary to
carry out the proposed
research work. The PD/PI must be capable of providing both
administrative and scientific leadership to the development and implementation of the
proposed research programs. At least one PD/PI for the clinical site should
be a board-certified pediatrician in an IDeA State.
PD/PI(s) will supervise the development and conduct of ECHO ISPCTN clinical research at
their institution and any participating partner performance site.
To enhance the research expertise and potential t
o build capacity to include needed expertise
on multicenter clinical trial proposals, ECHO ISPCTN Clinical Site and DCOC applicants may
propose collaborations. Applicants may consider collaborating with
other components or investigators within their own state or in other IDeA or non-IDeA states.
For partner institutions from non-IDeA States, total budget per year should be no more than
25% of the total annual cost awarded to the applicant organization.
Applicants are encouraged to leverage resou
rces and facilities supported by other NIH programs
such as the IDeA Program-Infrastructure for Clinical and Translational Research or IDeA-CTR,
and the Clinical and Translational Science Award (CTSA) Program.
A letter of intent is not required; however, such a letter helps NIH staff to estimate
review workload and accordingly plan for the review of applications.
In the letter of intent, please include the five elements listed here, namely: descriptive
title of the proposed activity, PD/PI conta
ct information, contact information of the other
key personnel, participating institution or institutions, and the number and title of
this RFA. Please address the letter of intent to Dr.
Lisa Steele, spelled as L I S A, first name, S t e e l e, ‘Steele’, last name, PhD,
Centers for Scientific Review, MSC 7768, 6701 Rockledge Drive, Bethesda, Maryland, 20892-7768.
Her work phone number 301-257-2638, and her email address, lisa.steele@nih.gov.
The key dates to remember are: Letter of intent, whic
h is optional, due date
April 1st, 2024. Application due date April 15th, 2024.
Scientific Merit review October 2024. Advisory Council review January 2025.
Earliest estimated award date is May 2025, and then
the earliest estimated start date is June 2025.
Some suggestions for all applicants are shown on this slide.
Please read both funding opportunity announcements for the third cycle of ISPCTN that have been
published. And these are: RFA-OD-24-008 and RFA-OD-24-009.
Please read both frequently
asked questions on FAQ files, which are available on this
website. And these are the Word file for the Clinical Sites
RFA-OD-24-008 and the Word file for the Data Coordinating and Operations Center RFA-OD-24-009.
And please see both webinars available on this website, which are one for the Clinical
Sites RFA and the other one is for the Data Coordinating and Operations Center RFA.
If you have additional questions, please feel free to send me a note. My name is Tonse Raju.
I’m going to spell that
. My first name, T o n s e and my last name,
R a j u. And my email address is tonse.raju@nih.gov. Thank you very much for your interest in this
funding opportunity announcement.
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