Biostatistics

For standard experiments (no high-throughput measurements) recorded in spreadsheet files, samples/observations/replicates should be entered in rows, features/characteristics in columns. If multiple measurements per sample have been made (e.g. time series), each measurement should go into a separate row and an identifier variable for samples should be included. Column names should not contain any special signs. If measurements are coded, a legend must be provided. Dates should all be in the same format. If during the process of analysis your data must be updated or corrected, please provide an updated file without changing column names, formats etc. Information supplied by highlighting, coloring or any other type of formatting cannot be imported and used for the analysis.

The DKFZ provides SPSS SigmaPlot for standard analysis in a user-friendly environment. GraphPad Prism is another user-friendly statistical software frequently used at the DKFZ but without a campus-wide license. The Genomics and Proteomics Core Facility provides bioinformatics  tools for conducting standard microarray/sequencing analysis, such as Chipster and IPA. Our division generally uses R/Bioconductor and SAS for power/sample- size estimations.

We consider reproducible research to be essential for scientific work. For this reason, we prepare our analysis in R/Bioconductor in combination with Sweave/Knitr in order to allow for reproducibility of results, figures and tables. If requested, we can also provide stand-alone analysis scripts that can be used to reproduce results and can be submitted along with your manuscript.

We encourage PhD candidates and their supervisors to contact us whenever they need statistical advice on their experimental design, the methods to use, the correct application of statistical software, or the proper interpretation of results. We normally expect PhD candidates to perform the statistical analyses for their theses themselves. Of course, in case of a more complex analysis requiring advanced statistical knowledge and/or software expertise we will provide the necessary support.

Please email the division of Biostatistics at biostatistics-consulting(at)dkfz.de and briefly describe your experiment/question and your aim.

Lecture series for researchers and PhD students in the biological or clinical sciences without prior knowledge in statistics.

Topics:
 

• Descriptive statistics: plots, measures of location and spread
• Confidence intervals
• Statistical hypothesis testing, p-value, etc.
• Statistical tests for quantitative data, e.g., t-test
• Statistical tests for qualitative data, e.g., chi-square test
• Correlation and regression
• Study design

This lecture series accompanies "Basic Principles of Biostatistics" and shows how the methods introduced there are coded in R. Participants should have a working R installation on their computers.

Team-taught lecture series by members of the division of Biostatistics for researchers and PhD students in the biological or clinical sciences with basic knowledge of statistics.

Topics:

• Analysis of Variance
• Non-parametric methods
• Multiple linear regression
• Logistic regression
• Linear mixed models
• Dose-response modeling
• Diagnostic tests
• Measuring agreement
• Survival analysis: Kaplan-Meier curves, logrank tests, Cox PH regression
• Variable selection in regression
• Design of clinical trials
• Multiple Testing
• Introduction to Bayesian thinking

This lecture series accompanies "Advanced Topics in Biostatistics" and shows how the methods introduced there are coded in R. Participants should have some basic R programming skills, including the ability to use the basic statistical methods shown in the "Basic principles" course.
In addition to the courses organized by the division of Biostatistics, the Advanced Training department of the DKFZ also offers programming courses in R and SAS, and the Genomics and Proteomics Core Facility at DKFZ offers courses on specific data analysis tools for high-throughput genomics data. DKFZ employees please visit the Training Portal for further information.

The German-speaking Myeloma-Multicenter Group (GMMG) conducts active research to improve treatment methods for multiple myeloma. Therein our long-term collaboration with the GMMG has witnessed treatment modifications that have been/will be implemented in the German health system. So, the current standard of care for patients with newly diagnosed multiple myeloma includes chemo-combination therapy followed by autologous stem cell transplantation. Based on the analysis of the GMMG-MM5 trial, it was shown that patients aged 65 to 70 years benefit from stem cell transplantation in the same way as the age group <= 65 without additional safety risks [Mai EK, Miah K et al. 2021]. As a consequence, cost absorption of ASCT is now admissible for multiple myeloma patients up to the age of 70 years by statutory health insurances (cf. https://gmmg.info/atp/). In addition, in part 1 of the randomized phase III study GMMG-HD7, it could be shown that the addition of a novel immunotherapy client significantly reduces the risk of detecting residual disease in the bone marrow which is a surrogate for prolongation of progression-free survival. Based on the results of this IIT trial, the monoclonal antibody will be sought for regulatory approval [Goldschmidt et al 2022]. Furthermore, the test for free light chains in the blood has so far been an easy-to-use diagnostic tool for predicting tumor activity. It has now been shown that the normalization of free light chains has a prognostic impact on progression-free survival, allowing an individualized therapy for this subgroup of responding patients. [Klein EM, Tichy D et al., 2021]

The German-Austrian AML Study Group (AMLSG) is one of the world's largest study groups for the research and treatment of AML, initiating a number of innovative national and interventional clinical trials and running the AMLSG BiO Registry Study with around 1,500 newly diagnosed AML patients being recruited annually. All patients included in the AMLSG BiO Registry Study agree to a systematic central biobanking and undergo in-depth molecular and genetic diagnostics which allow for prestigious translational research projects that are published in high-impact journals. Members of the working group have been responsible statisticians in the clinical trials since the study group was founded in 2003 and support many of the accompanying research projects.

In cooperation with the Section of Allogeneic Stem Cell Transplantation at Heidelberg University Hospital we investigate the usefulness of EASIX as prognostic and predictive biomarker for several diseases and endpoints. For instance, we illustrate the prognostic and predictive value of EASIX for time-to-sepsis, the effectiveness of statin-based prophylaxis for non-relapse mortality in different EASIX subgroups and the prognostic value of EASIX for severe complications after CAR-T cell therapy.

• Goldschmidt et al. Addition of isatuximab to lenalidomide, bortezomib, and dexamethasone as induction therapy for newly diagnosed, transplantation-eligible patients with multiple myeloma (GMMG-HD7): part 1 of an open-label, multicentre, randomised, active-controlled, phase 3 trial. Lancet Hematology 9(11):e810-821 (2022). doi: 10.1016/S2352-3026(22)00263-0
• Klein EM, Tichy D et al. Prognostic Impact of Serum Free Light Chain Ratio Normalization in Patients with Multiple Myeloma Treated within the GMMG-MM5 Trial. Cancers 13(9): 4856 (2021). DOI: 10.3390/cancers13194856
• Mai EK, Miah K. et al. Bortezomib-based induction, high-dose melphalan and lenalidomide maintenance in myeloma up to 70 years of age. Leukemia 35(12): 3636 (2021). doi: 10.1038/s41375-021-01357-4.
• Sauerbrei W, et al. STRengthening analytical thinking for observational studies: the STRATOS initiative. Stat Med. 33(30):5413-5432 (2014)

• Goldschmidt et al. Addition of isatuximab to lenalidomide, bortezomib, and dexamethasone as induction therapy for newly diagnosed, transplantation-eligible patients with multiple myeloma (GMMG-HD7): part 1 of an open-label, multicentre, randomised, active-controlled, phase 3 trial. Lancet Hematology 9(11):e810-821 (2022). doi: 10.1016/S2352-3026(22)00263-0
• Klein EM, Tichy D et al. Prognostic Impact of Serum Free Light Chain Ratio Normalization in Patients with Multiple Myeloma Treated within the GMMG-MM5 Trial. Cancers 13(9): 4856 (2021). DOI: 10.3390/cancers13194856
• Mai EK, Miah K. et al. Bortezomib-based induction, high-dose melphalan and lenalidomide maintenance in myeloma up to 70 years of age. Leukemia 35(12): 3636 (2021). doi: 10.1038/s41375-021-01357-4.
• Sauerbrei W, et al. STRengthening analytical thinking for observational studies: the STRATOS initiative. Stat Med. 33(30):5413-5432 (2014)