Institute for Transformative Clinical Trials (ITCT)

Apr 2, 2021 | Conduits News

Working in conjunction with ConduITS, the newly constituted Institute for Transformative Clinical Trials (ITCT) has as its mission the design, conduct, and analysis of innovative clinical trials that span the spectrum from early phase to confirmatory to large-scale pragmatic trials. What ITCT offers:

Expertise in the design and analysis of clinical trials

ITCT offers expertise in novel trial designs, including Bayesian and adaptive designs, bucket and platform trials, novel pragmatic and point-of-care trials, registry-based trials, and EHR-based trials, among others.  Institute faculty have designed trials with a broad array of outcomes and data types that encompass imaging data, genomic and biomarker data, and health economic data, in addition to the traditional morbidity and mortality data.  The Institute has extensive experience with patient-centered outcomes, such as return to independent living at home, cognitive status, quality of life and frailty.

In terms of analytical expertise, the Institute is experienced in conducting survival analysis, hierarchical modelling, cost-effectiveness modelling, longitudinal methods for analyzing quality of life and neuro-cognition, decision analysis, and predictive modelling using “big data”.

Expertise in the Coordination of Clinical Trials and Regulatory Compliance

ITCT offers coordinating center expertise, especially in the coordination of multi-site clinical trials.  The regulatory group assists in obtaining approvals for clinical trials from the FDA, Health Canada and European regulatory authorities, as well as from central and local IRBs.  It does the annual reporting to regulatory agencies.  The Institute has managed Event Adjudication Committees and DSMBs for an array of device, biological and procedural trials.

One area of specialization is the application of novel approaches to recruit and retain patients, and strategies to ensure the involvement of diverse and vulnerable populations.

Expertise in Data Collection for Multicenter Trials

ITCT has faculty with long-standing knowledge in the design of electronic data capture systems that are 21CFR part 11 compliant, include drug and device tracking, upload features for imaging data, and EAC modules. It also has a wealth of expertise in REDCap programming.

The Institute also collaborates with others Institutes at Sinai, offering expertise in digital health tools for collecting patient-derived outcomes and bio-wearables to collect data directly from patients.

ITCT faculty and staff welcome inquiries and are happy to provide consultations. Please e-mail or reach out to Melissa Chase at Melissa.chase@mountsinai.org or at 212-659-5967.

“ConduITS is supported by grant UL1TR001433 from the National Center for Advancing Translational Sciences, National Institutes of Health.”

Recent ConduITS News

The Mount Sinai ConduITS Informatics Core

Mount Sinai’s ConduITS Informatics Core is comprised of experts at the intersection of biomedical informatics, computational and data science, and artificial intelligence (AI). We partner with researchers and clinicians to utilize Mount Sinai’s computational and data...

read more

Trainee Corner

Mount Sinai CTSA Featured Trainees

Megan Januska

Megan Januska

Megan Januska, MD is an Assistant Professor in the Division of Pediatric Pulmonology in the Jack and Lucy Clark Department of Pediatrics and in the Department of Genetics and Genomic Sciences at the Icahn School of Medicine at Mount Sinai and Mount Sinai Kravis...

read more
Sangeetha Vadakke-Madathil

Sangeetha Vadakke-Madathil

Sangeetha Vadakke-Madathil, PhD, is currently a junior faculty (Instructor of Medicine) at Icahn School of Medicine at Mount Sinai, New York, NY. After receiving her Ph.D. degree in human hematopoietic stem cells and transplant biology from National Centre for Cell...

read more