Title
Pediatric Early Phase Clinical Trials Network (UM1)
Agencies
National Institutes of Health (NIH)
Description
The purpose of this Funding Opportunity Announcement (FOA) is to enhance NCI’s program for conducting early phase clinical trials in children with cancer, currently supported as the Children's Oncology Group (COG) Phase 1 & Pilot Consortium. The overall goal is to ensure that high priority novel agents can be tested in pediatric patients in a timely manner. Towards this end, applications are solicited for the Pediatric Early Phase Clinical Trials Network (PEP-CTN) to continue the clinical research activities now supported through the COG Phase 1 & Pilot Consortium.
The scope of the proposed PEP-CTN should cover the design and conduct of pediatric Phase 1 trials that will be expected to often include Phase 2 expansion cohorts. In addition, the Network will be expected to conduct pilot studies of novel regimens to determine their tolerability so that promising agents/regimens can proceed to definitive testing in Phase 3 clinical trials. These clinical trials should meaningfully advance pediatric oncology drug development during the award period. The awardee will lead the PEP-CTN Operations and Data/Statistics Center (ODSC) and will interact with selected Core Member institutions and Phase 2 Expansion Institutions on the conduct of early phase clinical trials.
This FOA is designed to enhance the existing program so that the Network can more efficiently and expeditiously develop and implement state-of-the-art early phase clinical trials. The important changes include:
Recognition of the need for seamless transitions from Phase 1 to Phase 2 testing, reflected by the modified initiative name (PEP-CTN) emphasizing "early phase" clinical trials;
The establishment of the Pediatric Early Phase (PEP) Agent Prioritization Committee to prioritize agents for evaluation by the PEP-CTN and to expedite the pace at which novel investigational agents enter clinical testing in pediatric patients;
The addition of central monitoring for all PEP-CTN clinical trials; and
Funds to support genomic characterization to establish eligibility and/or treatment assignment for PEP-CTN clinical trials and/or to facilitate factors determining the activity of agents studied by the PEP-CTN.
Applicants responding to this FOA must base their plans for the PEP-CTN institutional accrual base for Network clinical trials on the NCI's intention to include the current member institutions of the COG Phase 1/Pilot Consortium as the PEP-CTN Core Member Institutions. An additional 20 institutions are expected to be selected post-award to participate in Network clinical trials when additional accrual potential is needed (e.g., for Phase 2 expansion cohorts).
More Information
https://grants.nih.gov/grants/guide/rfa-files/RFA-CA-17-027.html
Submission Limits
Applicant institution may submit only one application as defined in Section III. 3. Additional Information on Eligibility.
Deadlines
Internal Notice of Intent |
Jun 22, 2017 |
Notification of Internal Competition |
Jun 23, 2017 |
Internal Pre-proposal |
Jun 30, 2017 |
Results of Internal Competition |
Jul 7, 2017 |
Agency Notice of Intent/Pre-proposal |
Jul 16, 2017 |
Agency Proposal |
Aug 16, 2017
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