TOMI-T1D is a JDRF and Diabetes UK funded international partnership between researchers from academic institutions, pharmaceutical industry and independent non-profit organizations. TOMI’s mission is to accelerate drug development and optimize immune intervention trials in T1D through the development of a composite outcome measure which 1) improves clinical interpretability and patient acceptability 2) shortens the time to primary outcome and 2) minimizes the number of participants required in trials.
To accomplish this, we are developing an open access Clinical Trial Simulation Tool (CTST) which will model anticipated drug and placebo effects based on variability that is specific and relevant to selected patient populations and that will also identify clinical endpoints for optimal clinical trial design. Our goal is to seek regulatory agency (FDA and EMA) endorsement of this CTST which may help facilitate 1) identification of appropriate clinical endpoints and 2) a clearer path for drug development T1D.
Our first step is to assemble a worldwide inventory of completed clinical trials and observational studies with the goal of identifying as many datasets as possible. This will ensure that we build a CTST based on robust data that can be endorsed by regulators and be used in confidence by the biopharmaceutical industry to optimize clinical trial designs. By combining patient level data across studies, the power and interpretability of individual studies are increased and importantly, the CTST will include data from studies where treatment effect may not have been demonstrated, but which are valuable in characterizing disease progression and heterogeneity in T1D.
For more information, please watch the TOMI-T1D video below and explore the information in the Data Contributors tab.