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.”
