Design, analysis, and reporting of diagnostic and prognostic trials in molecular imaging

---- Response evaluation -----

** Gerke (2020) PET/CT-based response evaluation in cancer – a systematic review of design issues. https://doi.org/10.1007/s11307-019-01351-4. (SharedIt: https://rdcu.be/byrOE ; Author’s Accepted Manuscript: https://www.ogy.dk)

** Vach (2011) How to study optimal timing of PET/CT for monitoring of cancer treatment. http://ajnmmi.us/files/ajnmmi1106001.pdf

----- Sequential and adaptive trial designs in diagnostic research -----

** Hot (2021) Randomized test-treatment studies with an outlook on adaptive designs. https://doi.org/10.1186/s12874-021-01293-y

** Vach (2021) The potential for seamless designs in diagnostic research. https://doi.org/10.1016/j.jclinepi.2020.09.019

** Zapf (2020) Adaptive trial designs in diagnostic accuracy research. https://doi.org/10.1002/sim.8430

** Gerke (2017) Group-sequential analysis may allow for early trial termination: illustration by an intra-observer repeatability study. http://rdcu.be/wd5R

----- Agreement -----           

** Diagnostics Special Issue “Planning and evaluating agreement and reliability studies”. https://www.mdpi.com/si/35356

** Vach (2021) How replicates can inform potential users of a measurement procedure about measurement error: basic concepts and methods. Diagnostics. 2021; 11(2):162. https://doi.org/10.3390/diagnostics11020162

** Möller (2021) An extension of the Bland-Altman plot for analyzing agreement of more than two raters. Diagnostics. 2021; 11(1): 54. https://doi.org/10.3390/diagnostics11010054

** Gerke (2020) Nonparametric Limits of Agreement in method comparison studies: a simulation study on extreme quantile estimation. https://doi.org/10.3390/ijerph17228330

** Frey (2020) Nonparametric Limits of Agreement – a simulation study. https://doi.org/10.3390/stats3030022

** Gerke (2020) Reporting standards for a Bland-Altman agreement analysis: a review of methodological reviews. https://doi.org/10.3390/diagnostics10050334

** Gerke (2018) Experience applying the Guidelines for Reporting Reliability and Agreement Studies (GRRAS) indicated five questions should be addressed in the planning phase from a statistical point of view. https://doi.org/10.3390/diagnostics8040069

** Gerke (2016) How to assess intra- and inter-observer agreement with quantitative PET using variance component analysis. http://rdcu.be/nhN5

Current position

Biostatistician, Department of Nuclear Medicine, Odense University Hospital & Professor in Clinical Biostatistics in Diagnostic Research, Dept. of Clinical Research, University of Southern Denmark

Former positions

2011-18 Associate Professor (20%), Dept. of Business and Economics, SDU

2006 Senior Statistician, Early Clinical Development, Novartis Pharma AG, Basel

2002-06 Biometrician, Clinical Statistics Europe, Schering AG, Berlin

2001/02 Junior Specialist, Information Resources GfK GmbH, Nürnberg

Higher education & academic degrees

2010 Lecturer Training Programme, University of Southern Denmark

2001 PhD, Institute of Statistics and Econometrics, Faculty of Economics, University of Hamburg

1998 MSc in Mathematics and Economics, University of Hamburg

Membership of scientific societies

International Biometric Society (IBS)

International Society for Clinical Biostatistics (ISCB)

German Statistical Society (DStatG)

Danish Society for Theoretical Statistics (DSTS)

Co-advisor of ongoing PhD projects: 5

Co-advisor of completed PhD projects: 20

Main supervision of completed master theses: 8

Teaching: BSc and MSc level

Odense, 26 October 2021