Core 5 - Biostatistics and Bioinformatics Core

Project Summary – Core 5 – Biostatistics and Bioinformatics Core Dana-Farber Cancer Institute Studies from the previous grant period confirmed that achieving MRD negative status provides significantly superior progression free and overall survival outcome. Moreover, the studies by IFM have shown that high dose chemotherapy followed by autologous stem cell transplant (HDT) provide significant PFS benefit. With the help of this Core, the results of the DFCI sites (determination study) were just recently unblinded showing a significant benefit of HDT even with maintenance till progression. With the help of this Core, the new proposal for clinical study was developed in this renewal application to address how MRD status can inform the therapeutic approach. The proposal is to perform a randomized phase III study comparing HDT versus additional cycles of induction therapy for MRD negative patients and single versus tandem HDT for MRD positive patients. Moreover along with clinical information a large amount of genomic and epigenomic data has been generated using the patients samples that requires integrated analysis. In the prior funding period the Core has supported all the projects with planning, analysis and integration. In this proposal Core will continue to support this effort and will provide 1) support and direction on the formatting, quality control and annotation procedures of clinical and research data as well as the process of transferring the research data a data warehouse for integrative analysis, 2) bioinformatics support for primary and integrative analysis of the high-throughput data and 3) biostatistics support in terms of design and analysis for all projects. Core members will work closely with all project members as well as Cores 1 and 2 with regard to quality control, specimen tracking and data transfer procedures as well as Cores 3 and 4 which will perform next generation sequencing for identifying genomic, epigenomic and transcriptomic changes at bulk and single cell level. Bioinformatics and biostatistics support and analysis is not only required for individual projects, but it is crucial for the integrative analysis from data across the projects and thus overall success of the program.