Clinical Trials and Organ Transplantation Come Together in Reissued Funding Opportunity

Funding News Edition: May 20, 2020
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To improve our understanding of immune-mediated causes of morbidity and mortality in transplant recipients, evaluate interventions to address them, and ultimately improve transplant outcomes.

Such are the goals of the research sought through the reissued funding opportunity announcement (FOA) Clinical Trials in Organ Transplantation in Children and Adults (CTOT-CA) (U01, Clinical Trial Optional). The FOA represents a merger and expansion of two prior research consortia: the Clinical Trials in Organ Transplantation (CTOT) and the Clinical Trials in Organ Transplantation in Children (CTOT-C).

Consider applying if you want to participate in a clinical studies/clinical trials program to improve outcomes of recipients of thoracic or abdominal organ transplants, vascularized composite allografts, or cell replacement allografts (e.g., pancreatic islet or hepatocyte transplants).

The CTOT-CA will support a cooperative, multi-institutional consortium for conducting interventional trials (Phase 1, 2, or 3) or observational clinical studies in adult and/or pediatric candidates for or recipients of allogeneic organ, vascularized composite tissue, or cellular replacement transplants requiring lifelong immunosuppression under the current standard of care.

Each clinical study must include associated mechanistic studies that focus on immune-mediated pathologic processes in allotransplantation, including but not limited to: mechanisms of immune activation and quiescence; biomarkers of immune activation, rejection, or tolerance; the interplay of alloimmunity and pathogen response; and mechanisms of susceptibility to/protection from infection that are particularly relevant to transplant recipients.

Examples of clinical trials, observational studies, and associated mechanistic studies include the following (see the FOA, linked above, for others as well as nonresponsive study types that will not be reviewed):

  • Evaluating improved, less toxic, or more specific immunosuppressive agents or regimens
  • Interventions in the living or deceased donor that will result in improved recipient outcomes
  • Identifying and validating biomarkers that will enable accurate non- or minimally-invasive monitoring of the recipient’s immunoreactive state, so that therapy can be individualized and proactive
  • Prospective observational studies characterizing the course of viral, fungal, or mycobacterial infections in the organ transplant population that address key unknowns and correlates of risk

Milestones and Other Program Details

Note that the CTOT-CA program is milestone-based, with the flexibility to quickly redirect or replace research projects during the funding period. Before award, applicants and NIAID staff will negotiate milestones that will be reviewed on an annual basis.

Refer to the FOA to learn about Program components, such as data coordination and management and clinical trial support, CTOT-CA steering committee and associated subcommittees, and an Ancillary Studies Fund (ASF).

Award, Budget, and More

NIAID intends to commit $17 million in fiscal year 2021 to fund five to seven awards, including $4 million annually to support an ASF.

Application budgets are not limited but need to reflect the actual needs of the proposed project. NIAID anticipates that the yearly direct costs per award for clinical trials and/or studies will be approximately $2 million, not including the ASF.

If you have questions about the FOA, touch base with Dr. Nancy Bridges or Dr. Jonah Odim, our scientific/research contacts.

Applications are due October 9, 2020.

Lastly, to learn more about the Program, go to its websites Clinical Trials in Organ Transplantation (CTOT) and Clinical Trials in Organ Transplant in Children (CTOT-C).

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