Center for Clinical Research

To improve care for infants, children, and adolescents with acute and chronic medical conditions, the Center for Clinical Research is pursuing breakthrough studies through groundbreaking clinical trials.

Identification and testing of novel therapies requires a rigorous clinical trials program with robust infrastructure to support a vast diversity of therapeutic studies.  Our clinical trials team undertakes interventional studies ranging from Phase I assessment of toxicity of a new agent, to Phase II efficacy evaluations, to Phase III trials aimed at determining whether a new therapy will improve care for patients when compared to a previously determined standard of care.

The collaboration between the clinical trials program and our scientific leaders provides for investigative growth in both programs, with fresh discoveries leading to new clinical trials and innovative treatments for the children and families we serve.

Connecticut Children’s investigators partner with various Sponsors to facilitate multi-center trials including rare disease in neurology, nephrology and endocrinology, gastrointestinal disorders, hematological and oncological disorders, neonatology, and infectious disease. Additionally, investigators seek funding opportunities for investigator-initiated trials. Many are national leaders in their field of study. Some examples of this work include the following:

Gastrointestinal Disorders:  Dr. Jeffrey Hyams will lead an NIDDK-funded multi-site project called CAMEO: Clinical, Imaging, and Endoscopic Outcomes of Children Newly Diagnosed with Crohn’s Disease. This study will be conducted across 20+ sites, with Connecticut Children’s participating as the lead site. CAMEO will examine the association between pre-treatment clinical, radiologic, genomic, and microbial factors and a patient’s ability to achieve complete healing after one year of optimized anti-TNF therapy. This will include personalized anti-TNF biologic therapy guided by therapeutic drug monitoring and a novel dosing algorithm developed by the study team.

Hematological/Oncological Disorders: Dr. Mike Isakoff is the site PI for Children’s Oncology Group, an international consortium of pediatric oncology centers aimed at conducting Phase I, II, and III clinical trials along with biology studies for children, adolescents and young adults with cancer. Dr. Isakoff, in partnership with his scientific and medical collaborators world-wide, pursues vital investigative research to identify cancer pathologies and treatment models for children and families.

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