Approach
Following a comprehensive, multidimensional approach, we will study seven diseases both in parallel and jointly using a combination of data and samples from three main sources:
1) academic study collections funded external to 3TR (e.g. PRECISESADS, PEAC);
2) industry-driven clinical trial data (e.g. BENREX);
3) a de novo observational prospective study collection of patients treated with standard of care (SOC) therapy.
In total, 3TR will have access to an unprecedented quantity of clinical data and samples of more than 50,000 patients across 50 clinical trials.
The various sources of data available in 3TR vary greatly with regard to their stage of progression: some will have been completed, others – as the prospective trial for instance – will be just started. Aiming to swiftly and flexibly analyse new data as it is produced and processed, we will adopt a dynamic Carousel Model: Data generated by the different studies will be integrated and analysed in the carousel backbone once their profiling is completed in order to be cross-verified with subsequent collections of data entering the carousel or to be meta-analysed across diseases or for single diseases. Each entered data set will confirm or verify the previous one, independently.
At the beginning, existing studies will be analysed and harmonised, and a decision on profiling needs will be taken. The types of trials envisioned are:
a) finalised trials without additional profiling needs;
b) finalized trials with additional profiling needs;
c) prospective trials brought into the project by different participants; and
d) dedicated prospective observational trial.
Industry will design and align its planned trials as much as possible with the 3TR trial.