The Clinical Trials Unit (CTU) provides a range of support services pertaining to protocol development, implementation, and closeout for our clinical trials. Lead by Giovanni Cizza, M.D., Ph.D., M.H.Sc., Chief Medical Officer, the CTU has an impressive team comprised of a:
- Senior Clinical Trials Specialist
- Senior Regulatory Affairs Specialist
- Clinical Research Associate
- Research Coordinator
This team assists with trial design, feasibility assessments, site developments, monitoring requirements, regulatory guidance, and project management. Additionally, they track each trial’s process to ensure efficiency and attainment of our rigorous ethical and scientific standards. The CTU collaborates closely and is in constant dialogue with our Clinical and Translational Research Divisions. This continuous feedback ensures synergistic and systematic efforts across our work.
The CTU and the clinical cores work together to design trials that optimize feasibility, efficacy, and efficiency. The CTU also works closely with the Translational Research Division to help design preclinical interventional trials that apply clinical trial standards to their data collection and statistical analysis plans. Doing so enhances the potential of translating new preclinical treatments into successful future clinical trials. Promising therapeutics from the Translational Research Division are shared with the CTU and are accompanied with the data necessary to plan study designs for decisive early phase clinical trials.