Clinical Trials in Organ Transplantation (CTOT)

Improving outcomes for transplant recipients

The Clinical Trials in Organ Transplantation (CTOT) 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) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). CTOT is an investigative consortium for conducting clinical and associated mechanistic studies that will lead to improved outcomes for transplant recipients. The purpose of these studies is to improve short and long-term graft and patient survival.

CTOT supports research to:

• Evaluate new therapeutic regimens to overcome immunologic barriers to graft acceptance and/or long-term graft and patient survival;
• Evaluate approaches to the treatment or prevention of immune-mediated complications of transplantation;
• Investigate the underlying mechanisms of action of the pathologic processes, agents or regimens under study; and
• Develop diagnostic tests for and/or surrogate biomarkers that will facilitate routine surveillance, early diagnosis, and ongoing monitoring of those processes that contribute to post-transplant morbidity and mortality.

Visit the CTOT 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.