Clinical Trials in Organ Transplantation in Children (CTOT-C)

Improving outcomes for pediatric transplant recipients

The Clinical Trials in Organ Transplantation in Children (CTOT-C) project is a cooperative research program sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), with co-funding from the National Heart, Lung and Blood Institute (NHLBI). CTOT-C is an investigative consortium for conducting multi-institutional clinical and associated mechanistic studies that will lead to improved outcomes for pediatric transplant recipients. The purpose of these studies is to improve short and long-term graft and patient survival in children who have undergone heart, lung or kidney transplantation.

Visit the CTOT-C website for more information.

As the Statistical and Clinical Coordinating Center (SACCC) for the CTOT program, Rho’s responsibilities encompass a broad range of functions for the clinical trials and mechanistic studies, which include:

• statistical design and analysis,
• computer-based data collection and management,
• database storage and management,
• quality control,
• reporting and associated training for clinical site personnel,
• safety oversight and reporting of serious adverse events (SAEs),
• regulatory guidance and support for investigational new drugs (INDs),
• clinical site monitoring,
• operational support,
• management of study drug supply to sites,
• preparation of study-related materials, and
• website development and maintenance.

Project team members coordinate activities to support the design and conduct of a series of clinical, mechanistic, and biomarker studies. Rho statisticians provide leadership for the design and analysis of clinical trials and studies of underlying mechanisms. They also collaborate with clinicians during concept development, providing statistical and clinical trial expertise essential to creating the protocol. The administrative and infrastructure support tools established for this project include:

• EDC and randomization systems,
• specimen tracking systems,
• a secure website,
• standard operating procedures, and
• document templates.

David Iklé (Ph.D., Senior Statistical Scientist) is the Principal Investigator (PI) for this coordinating center.