Key Dates

Related Announcements

• April 15, 2020 - Clinical Trials in Organ Transplantation in Children and Adults (CTOT-CA) (U01 Clinical Trial Optional). See NOFO RFA-AI-20-029.
• July 29, 2013 - Clinical Trials in Organ Transplantation (CTOT) (U01). See NOFO RFA-AI-13-006.
• January 4, 2012 - Clinical Trials in Organ Transplantation in Children (U01). See NOFO RFA-AI-12-005.
• June 12, 2008 - Clinical Trials in Organ Transplantation (CTOT/U01). See NOFO RFA-AI-08-015.
• January 12, 2007 - Clinical Trials in Organ Transplantation in Children (U01). See NOFO RFA-AI-07-006.
• December 9, 2003 - Clinical Trials in Organ Transplantation (CTOT). See NOFO RFA-AI-04-003.

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The National Institute of Allergy and Infectious Diseases (NIAID) is seeking input to enhance the Clinical Trials in Organ Transplantation in Children and Adults (CTOT-CA) cooperative research program.

Background

NIAID has sponsored highly successful cooperative research in solid organ transplantation for over two decades through three initiatives: 1) Clinical Trials in Organ Transplantation (CTOT, initiated in FY04); 2) Clinical Trials in Organ Transplantation in Children (CTOT-C, initiated in FY08); and 3) Clinical Trials in Organ Transplantation in Children and Adults (CTOT-CA, initiated in FY21).  These three initiatives solicited applications with rigorously designed clinical trials coupled with robust mechanistic studies with emphasis on improving patient outcomes through a better understanding of transplant immunology and collaboration across centers. With the participation of approximately 200 clinical sites and core laboratories, these consortia have enrolled nearly 7,000 participants in the conduct of 33 multi-center observational studies and interventional clinical trials in organ transplantation.

The scientific agenda and scope of studies have evolved from biomarker discovery and validation to early and late phase interventional trials of drugs, biologics, and cellular therapies.

The design and implementation of transplant clinical trials is highly challenging due to the severity of illness of the target population and the need to establish equipoise; the paucity of new drugs for the prevention and treatment of transplant rejection and the need to establish agreements with pharmaceutical partners to obtain investigational drugs and biologics; the impact of the organ allocation system on accrual projections; and regulatory requirements for the safe conduct of clinical trials. Nevertheless, prior and current CTOT studies have made important contributions to the field of transplantation, and the CTOT consortium is uniquely positioned to carry out impactful studies because of its well-developed infrastructure and well-established collaborations throughout the U.S. transplant clinical and research communities and with regulatory agencies.

Information Requested

In this Request for Information (RFI), NIAID seeks broad input from all stakeholders with an interest in improving outcomes in pediatric and adult solid organ transplant candidates and recipients through the next CTOT cooperative research initiative.

Areas of potential comment include, but are not limited to:

• The top three challenges solid organ transplantation will face over the next 10 years, with a focus on transplant immunology and outcomes.
• How the CTOT initiative can facilitate prompt study initiation after awards are made.
• How the CTOT consortium can be nimble in adapting to enrollment challenges, changes in the regulatory environment (including organ allocation policy changes), and introduction of new therapies or adoption of new protocols.
• Ways to increase utilization of existing CTOT clinical trial data and samples.
• Other approaches that would allow CTOT investigators to maximize their contributions to scientific insights and patient outcomes.

How to Submit a Response

RFI responses should be directed to Stuart Sweet, M.D., Ph.D., Chief, Transplant Branch, Division of Allergy, Immunology and Transplantation (DAIT), National Institute of Allergy and Infectious Diseases (NIAID) via e-mail at [email protected].

Responses must be received by January 19, 2026.

Responses to this RFI are voluntary. This RFI is for planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government, the National Institutes of Health, or NIAID. The NIH does not intend to make any award in response to this RFI or to pay for either the preparation of information submitted or the Government’s use of such information.

Responses should be limited to no more than 3 pages and emailed as an attachment (Microsoft Word or PDF). No proprietary, classified, confidential, or sensitive information should be included in your response. Submitted data and information will not be returned and will not be considered confidential.

Inquiries

Please direct all inquiries to:

Stuart Sweet M.D., Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-255-5649
Email: [email protected]