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Department of Medical Statistics
Norbert Benda

PD Dr. Norbert Benda

Research Associate Working Group Statistical Methods for Clinical Trials

telephone: +49 551 3961193

fax: +49 551 3965605

e-Mail address: norbert.benda(at)med.uni-goettingen.de

location: Humboldtallee 32, GF 0.164

Short biography

[Since 2025]
Scientific Officer, Department of Medical Statistics, University Medical Center Göttingen, Germany

[Since 2025]
Statistical Consultant to the Icelandic Medicine Agency (Lyjastofnun), Reykjavík, Iceland

[2010 – 2025]
Head of Biostatistics and Special Pharmacokinetics Unit, Federal Institute for Drugs and Medical Devices, Bonn, Germany

[2015]
Appointed as Lecturer (Habilitation), Venia Legendi for “Medical Statistics”, University Medical Center Göttingen, Germany

[2006 - 2010]
(Senior) Expert Statistical Methodologist, Novartis AG, Basel, Switzerland

[1997 - 2006]
Statistician, Schering AG, Berlin, Germany

[1993 - 1997]
Research Assistant, Department of Medical Biometry, University of Tübingen, Germany

[1989 - 1993]
Research Assistant, Institute of Mathematics, Free University of Berlin, Germany

[1992]
Doctorate (Dr. re. nat.) in Mathematics (Mathematical Statistics), Institute of Mathematics, Free University of Berlin, Germany

[1988]
Diploma in Mathematics, Technical University of Aachen (RWTH Aachen), Germany

Publications

Further publications since 2010

  1. Karres D, Pino-Barrio MJ, Benchetrit S, Benda N, Cochat P, Galluzzo S, García-Solís A, Gonzalez S, de Lisa R, Khan D, Lankester R, Lentz F, Martínez-Ortega PA, Montilla S, Morales DR, Musuamba Tshinanu F, Pulido Sánchez S, Rossignoli Montero A, Scherer S, Thomson A, Torres Garrido B, Umuhire D, Wang S, Bax R, Hedberg N (2024). Evidence generation throughout paediatric medicines lifecycle - current experience and challenges from a regulatory and Health Technology Assessment perspective – learnings from the collaborative work between the European Medicines Agency and the European network for Health Technology Assessment on use of extrapolation. British Journal of Pharmacology, https://doi.org/10.1111/bph.17396.
  2. Liu X, Benda N, Mittmann C, Koch A (2025). Combining recurrent and terminal events into a composite endpoint may be problematic. Statistics in Biopharmaceutical Research17, 417–424. https://doi.org/10.1080/19466315.2024.2395404.
  3. Hot A, Benda N, Bossuyt PM, Gerke O, Vach W, Zapf A (2022). Sample size recalculation based on the prevalence in a randomized test-treatment study. BMC Med Res Methodol. 22(1):205.
  4. Kesselmeier M, Benda N, Scherag A (equal contributions of all authors) (2020). Effect size estimates from umbrella designs: handling patients with a positive test result for multiple biomarkers using random or pragmatic subtrial allocation. PLOS One. Published online: 14 Aug 2020.
  5. Benda N, Haenisch B (2020). Enrichment designs using placebo nonresponders. Pharm Stat.  19(3):303-314.
  6. Prus M, Benda N, Schwabe R (2020). Optimal Design in Hierarchical Random Effect Models for Individual Prediction with Application in Precision Medicine. Journal of Statistical Theory and Practice14(2).
  7. Holtkamp F, Gudmundsdottir H, Maciulaitis R, Benda N, Thomson A, Vetter T (2020). Change in Albuminuria and Estimated GFR as End Points for Clinical Trials in Early Stages of CKD: A Perspective From European Regulators. Am J Kidney Dis.75(1):6-8.
  8. Hampel H, Vergallo A, Afshar M, Akman-Anderson L, Arenas J, Benda N, Batrla R, Broich K, Caraci F, Cuello AC, Emanuele E, Haberkamp M, Kiddle SJ, Lucía A, Mapstone M, Verdooner SR, Woodcock J, Lista S (2019). Blood-based systems biology biomarkers for next-generation clinical trials in Alzheimer's disease. Dialogues Clin Neurosci.21(2):177-191.
  9. Graf von Kielmansegg S, Benda N, Grass G, Sudhop T (2019). Die Rolle von Ethikkommissionen bei der Bewertung klinischer Arzneimittelprüfungen [Ethics committees in clinical trials involving medicinal products]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 62(6):706-712. German.
  10. Unkel S, Amiri M, Benda N, Beyersmann J, Knoerzer D, Kupas K, Langer F, Leverkus F, Loos A, Ose C, Proctor T, Schmoor C, Schwenke C, Skipka G, Unnebrink  K, Voss F, Friede T (2019). On estimands and the analysis of adverse events in the presence of varying follow-up times within the benefit assessment of therapies. Pharm Stat. 18(2):166-183.
  11. Friede T, Posch M, Zohar S, Alberti C, Benda N, Comets E, Day S, Dmitrienko A, Graf A, Günhan BK, Hee SW, Lentz F, Madan J, Miller F, Ondra T, Pearce M, Röver C, Toumazi A, Unkel S, Ursino M, Wassmer G, Stallard N (2018). Recent advances in methodology for clinical trials in small populations: the InSPiRe project. Orphanet J Rare Dis. 25;13(1):186. Review.
  12. Hampel H, Vergallo A, Aguilar LF, Benda N, Broich K, Cuello AC, Cummings J, Dubois B, Federoff HJ, Fiandaca M, Genthon R, Haberkamp M, Karran E, Mapstone M, Perry G, Schneider LS, Welikovitch LA, Woodcock J, Baldacci F, Lista S (2018). Alzheimer Precision Medicine Initiative (APMI). Precision pharmacology for Alzheimer's disease. Pharmacol Res. 130:331-365.
  13. Benda N, Brandt A (2018). Regulatory issues with multiplicity in drug approval: Principles and controversies in a changing landscape. J Biopharm Stat. 28(1):3-9.
  14. Benda N, Bürkner PC, Freise F, Holling H, Schwabe R (2017). Adaptive designs for quantal dose-response experiments with false answers. Journal of statistical theory and practice11, 361-374.
  15. Leuchs AK, Brandt A, Zinserling J, Benda N (2017). Disentangling estimands and the intention-to-treat principle. Pharm Stat 16, 12-19.
  16. Klaus V, Bastek H, Damme K, Collins LB, Frötschl R, Benda N, Lutter D, Ellinger-Ziegelbauer H, Swenberg JA, Dietrich DR, Stemmer K (2017). Time-matched analysis of DNA adduct formation and early gene expression as predictive tool for renal carcinogenesis in methylazoxymethanol acetate treated Eker rats. Arch Toxicol 91, 3427-3438.
  17. Musuamba FT, Manolis E, Holford N, Cheung S, Friberg LE, Ogungbenro K, Posch M, Yates J, Berry S, Thomas N, Corriol-Rohou S, Bornkamp B, Bretz F, Hooker AC, Van der Graaf PH, Standing JF, Hay J, Cole S, Gigante V, Karlsson K, Dumortier T, Benda N, Serone F, Das S, Brochot A, Ehmann F, Hemmings R, Rusten IS (2017). Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4-5 December 2014). CPT Pharmacometrics Syst Pharmacol 6, 418-429.
  18. Manolis E, Brogren J, Cole S, Hay JL, Nordmark A, Karlsson KE, Lentz F, Benda N, Wangorsch G, Pons G, Zhao W, Gigante V, Serone F, Standing JF, Dokoumetzidis A, Vakkilainen J, van den Heuvel M, Mangas Sanjuan V, Taminiau J, Kerwash E, Khan D, Musuamba FT, Skottheim Rusten I; EMA Modelling and Simulation Working Group (2017). Commentary on the MID3 Good Practices Paper. CPT Pharmacometrics Syst Pharmacol 6, 416-417.
  19. Hampel H, O'Bryant SE, Castrillo JI, Ritchie C, Rojkova K, Broich K, Benda N, Nisticò R, Frank RA, Dubois B, Escott-Price V, Lista S (2016). Precision Medicine - The Golden Gate for Detection, Treatment and Prevention of Alzheimer's Disease. J Prev Alzheimers Dis 3, 243-259.
  20. Stingl JC, Kaumanns KL, Claus K, Lehmann ML, Kastenmüller K, Bleckwenn M, Hartmann G, Steffens M, Wirtz D, Leuchs AK, Benda N, Meier F, Schöffski O, Holdenrieder S, Coch C, Weckbecker K (2016). Individualized versus standardized risk assessment in patients at high risk for adverse drug reactions (IDrug) – study protocol for a pragmatic randomized controlled trial. BMC Fam Pract 26, 17-49.
  21. Unkel S, Röver C, Stallard N, Benda N, Posch M, Zohar S, Friede T (2016). Systematic reviews in paediatric multiple sclerosis and Creutzfeldt-Jakob disease exemplify shortcomings in methods used to evaluate therapies in rare conditions. Orphanet J Rare Dis 20, 11-16.
  22. Leuchs AK, Zinserling J, Brandt A, Wirtz D, Benda N (2015). Choosing appropriate estimands in clinical trials. Therapeutic Innovation & Regulatory Science 49, 584-592.
  23. Helms HJ, Benda N, Zinserling J, Kneib T, Friede T (2015). Spline-based procedures for dose-finding studies with active control.Statistics in Medicine34, 232-248.
  24. Helms HJ, Benda N, Friede T (2015). Point and interval estimators of the target dose in clinical dose-finding studies with active control.Journal of Biopharmaceutical Statistics 25, 939–957.
  25. Dette H, Kiss C, Benda N, Bretz F (2014). Optimal designs for dose finding studies with an active control. Journal of the Royal Statistical Society: Series B (Statistical Methodology) 76, 265–295.
  26. Leuchs AK, Zinserling J, Schlosser-Weber G, Berres M, Neuhäuser M, Benda N (2014). Estimation of the treatment effect in the presence of noncompliance and missing data. Statistics in Medicine 33. 193-208.
  27. Großhennig A, Benda N, Koch, A (2013). Die Bedeutung von Biomarkern für eine personalisierte Medizin. Bundesgesundheitsblatt 56, 1480-1488.
  28. Benda N, Bender R (2011). Multiplicity Issues in Clinical Trials. Biometrical Journal 53, 873-874. Editorial.
  29. Benda N (2010). Model-based approaches for time dependent dose finding with repeated binary data. Statistics in Medicine 29, 1096-1106.
  30. Benda N, Branson M, Maurer W, Friede T (2010). Modernizing drug development using clinical scenario planning and evaluation. Drug Information Journal 44, 299-315.
  31. Akacha M, Benda N (2010). The impact of dropouts on the analysis of dose-finding studies with recurrent event data. Statistics in Medicine 29, 1635-1646.
  32. Benda N, Brannath W, Bretz F, Burger HU, Friede T, Maurer W, Wang SJ (2010). Perspectives on the use of adaptive designs in clinical trials: Part II. Panel Discussion. Journal of Biopharmaceutical Statistics 20, 1098-1112.

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