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Dr. Edward L. Korn

Mathematical Statistician, Biostatistics Branch

Biosketch

Edward L. Korn, PhD, has been a statistician with the National Cancer Institute since 1989. Before that he was at the UCLA School of Medicine for 11 years where he held the title of Associate Professor. Dr Korn holds a BS degree in mathematics from the University of Maryland and a PhD degree in statistics from Stanford. He is a Fellow of the American Statistical Association and a Fellow of the AAAS, and co-winner of the 1996 B.F. and H.E. Dewel Award. He is co-author of over 250 publications including being co-author of two books. He is currently on the data safety and monitoring boards for the Southwest Oncology Group, the Alliance for Clinical Trials in Oncology, and the National Cancer Institute of Canada Clinical Trials Group. Dr. Korn is a Deputy Editor of Clinical Trials and a Statistical Editor of Journal of the National Cancer Institute, and serves on the NCI Thoracic Malignancy Steering Committee.

Research Interests

Clinical trials methodology, statistical methods.

Selected Publications:

Korn EL (1986). Censoring distributions as a measure of follow-up in survival analysis. Statistics in Medicine 5, 255-260.

Graubard BI and Korn EL (1987). Choice of column scores for testing independence in ordered 2 X K contingency tables. Biometrics 43, 471-476.

Korn EL and Simon R (1990). Measures of explained variation for survival data. Statistics in Medicine 9, 487-503.

Korn EL and Graubard BI (1991). Epidemiologic studies utilizing surveys: Accounting for the sampling design. American Journal of Public Health 81, 1166-1173.

Korn EL and Dorey FJ (1992). Applications of crude incidence curves. Statistics in Medicine 11, 813-829.

Korn EL, Midthune D, Chen TT, Rubinstein LV, Christian MC and Simon R (1994). A comparison of two phase I trial designs. Statistics in Medicine 13, 1799-1806.

Korn EL, Graubard BI and Midthune, D (1997). Time-to-event analyses of longitudinal followup of a survey: choice of the time-scale. American Journal of Epidemiology 145, 72-80.

Korn EL and Graubard BI. Analysis of Health Surveys. New York: John Wiley and Sons, 1999.

Graubard BI and Korn EL (1999). Predictive margins with survey data. Biometrics 55, 652-659.

Korn EL, Arbuck SG, Pluda JM, Simon R, Kaplan RS, and Christian MC (2001). Clinical trial designs for cytostatic agents: Are new approaches needed? Journal of Clinical Oncology 19, 265-272

Simon RM, Korn EL, McShane LM, Radmacher MD, Wright GW and Zhao Y. Design and Analysis of DNA Microarray Investigations. Springer-Verlag New York, 2003.

Korn EL, Troendle JF, McShane LM and Simon R (2004). Controlling the number of false discoveries: application to high-dimensional genomic data. Journal of Statistical Planning and Inference 124, 379-398.

Rubinstein LV, Korn EL, Freidlin B, Hunsberger S, Ivy SP, and Smith MA (2005). Design issues of randomized phase II trials and a proposal for phase II screening trials. Journal of Clinical Oncology 23, 7199-7206.

Korn EL, Liu PY, Lee SJ, Chapman JW, Niedzwiecki D, et al (2008). Meta-Analysis of Phase II Cooperative Group Trials in Metastatic Stage IV Melanoma: Determining Progression-Free and Overall Survival Benchmarks for Future Phase II Trials. Journal of Clinical Oncology 26, 527-534.

Freidlin B, McShane LM, and Korn EL (2010). Randomized clinical trials with biomarkers: design issues. Journal of the National Cancer Institute 102, 152-160.

Korn EL and Freidlin B (2010). Causal inference for definitive clinical endpoints in a randomized clinical trial with intervening nonrandomized treatments. Journal of Clinical Oncology 28, 3799-3800.

Freidlin B, Korn EL and Gray R (2010). A general inefficacy interim monitoring rule for randomized clinical trials. Clinical Trials 7, 197-208.

Korn EL and Freidlin B (2011). Outcome-adaptive randomization: is it useful? Journal of Clinical Oncology 29, 771-776.

Dodd LE, Korn EL, Freidlin B, Gray R, and Bhattacharya S (2011). An audit strategy for progression-free survival. Biometrics 67, 1092-1099.

Korn EL and Freidlin B (2011). Inefficacy monitoring procedures in randomized clinical trials: the need to report. American Journal of Bioethics 11, 2-10.

Korn EL, Freidlin B, and Abrams JS (2011). Overall survival as the outcome for randomized clinical trials with effective subsequent therapies. Journal of Clinical Oncology 29, 2439-2442.

Korn EL, Freidlin B, Abrams JS and Halabi S (2012). Design issues in randomized phase II/III trials. Journal of Clinical Oncology 30, 667-671.

Freidlin B, McShane LM, Polley M-Y C, and Korn EL (2012). Randomized phase II trial designs with biomarkers. Journal of Clinical Oncology 30, 3304-3309.

Freidlin B and Korn EL (2013). Adaptive randomization versus interim monitoring. Journal of Clinical Oncology 31, 969-970.

Korn EL, McShane LM and Freidlin B (2013). Statistical challenges in evaluation of treatments for rare diseases and for small targeted patients subgroups. Science Translational Medicine 5, 178sr3.

Freidlin B and Korn EL (2013). Borrowing information across subgroups: Is it useful? Clinical Cancer Research 19, 1326-1334.

Polley M-Y, Freidlin B, Korn EL, Conley BA, Abrams JS, and McShane LM (2013). Statistical and practical considerations for clinical evaluation of predictive biomarkers. Journal of the National Cancer Institute 105, 1677-1683.

Freidlin B, Sun ZX, Gray R, and Korn EL (2013). Phase III clinical trials that integrate treatment and biomarker evaluation. Journal of Clinical Oncology 31, 3158-3161.

Freidlin B, Korn EL, Gray R (2014). Marker sequential test (MaST) design. Clinical Trials 11, 19-27.

Freidlin B and Korn, EL (2014). Biomarker enrichment strategies: matching trial design to biomarker credentials. Nature Reviews Clinical Oncology 11, 81-90.

Korn EL, Dignam JJ, and Freidlin B (2015). Assessing treatment benefit with competing risks not affected by the randomized treatment. Statistics in Medicine 34, 265-280.

Freidlin B, Little RF, and Korn EL (2015). Design issues in randomized clinical trials of maintenance therapies. Journal of the National Cancer Institute 107(11): djv225

Freidlin B, Othus M, and Korn EL (2016). Information time scales for interim analyses of randomized clinical trials. Clinical Trials 13:391-399.

Korn EL, Sachs MC, and McShane LM (2016). Statistical controversies in clinical research: assessing pathologic complete response as a trial-level surrogate end point for early-stage breast cancer. Annals of Oncology 27:10-15.

Korn EL and Freidlin B (2016). Non-factorial analyses of two-by-two factorial trial designs. Clinical Trials 651-659.

Zhang Q, Freidlin B, Korn EL, Halabi S, Mandrekar S, and Dignam J (2016). Comparison of futility monitoring guidelines using completed phase III oncology trials. Clinical Trials 14, 48-58.

Korn EL and Freidlin B (2017). Adaptive clinical trials: advantages and disadvantages of various adaptive design elements. Journal of the National Cancer Institute 109, djx013.

Korn EL, Othus M, Chen T and Freidlin B (2017). Assessing treatment efficacy in the subset of responders in a randomized clinical trial. Annals of Oncology 28, 1640-1647.

Freidlin B and Korn EL (2017). Two-by-two factorial cancer treatment trials: is sufficient attention being paid to possible interactions? Journal of the National Cancer Institute 109, djx146.

Freidlin B and Korn EL (2017). Sample size adjustment designs with time-to-event outcomes: a caution. Clinical Trials 14, 597-604.

Korn EL and Freidlin B (2018). Quantitative assessment of a prognostic or predictive biomarker panel. Journal of Biopharmaceutical Statistics. Journal of Biopharmaceutical Statistics 28:264-281.

Korn EL and Freidlin B (2018). Interim monitoring for non-inferiority trials: minimizing patient exposure to inferior therapies. Annals of Oncology 29: 573-577.

Korn EL and Freidlin B (2018). Surrogate and Intermediate Endpoints in Randomized Trials: What's the Goal? Clinical Cancer Research 10: 2239-2240.

Freidlin B, Korn EL and Abrams JS (2018). Bias, operational bias, and generalizability in phase II/III trials. Journal of Clinical Oncology 36: 1902-1904.

Korn El and Freidlin B (2018). Interim futility monitoring assessing immune therapies with a potentially delayed treatment effect. Journal of Clinical Oncology 36: 2444-2449.

Cook JA, Fergusson DA, Ford I, Gonen M, Kimmelman J, Korn EL and Begg CB (2019). There is still a place for significance testing in clinical trials. Clinical Trials 16:223-224.

Polley MC, Korn EL, and Freidlin B (2019). Phase III precision medicine clinical trial designs that integrate treatment and biomarker evaluation. JCO Precision Oncology (DOI https://doi.org/10.1200/PO.18.00416).

Yee LM, McShane LM, Freidlin B, Mooney MM, and Korn EL (2019). Biostatistical and logistical considerations in the development of basket and umbrella clinical trials. Cancer Journal 25: 254-263.

Korn EL, Gray RJ and Freidlin B (2019). Noninferiority trials with nonadherence to the assigned randomized treatment. Clinical Trials 16:673-681.

Freidlin B and Korn EL (2019). Methods for accommodating nonproportional hazards in clinical trials: ready for the primary analysis? Journal of Clinical Oncology 37:3455-3459.

Foster JC, Freidlin B, Kunos CA, and Korn EL (2020). Single-Arm Phase II Trials of Combination Therapies A Review of the CTEP Experience 2008-2017. JNCI 112(2): 128-135.

Freidlin B, Allegra CJ and Korn EL (2020). Moving molecular profiling to routine clinical practice: a way forward? JNCI 112 (8): 773-778.

Dahlberg SE, Korn EL, Le-Rademacher J and Mandrekar S. (2020). Clinical versus statistical significance in studies of thoracic malignancies. Journal of Thoracic Oncology 15:1406-1408.

Foster JC, Freidlin B, Korn EL, and Smith M. (2020). Evaluation of the contribution of randomized cancer clinical trials evaluating agents without documented single-agent activity. ESMO Open 5:e000871

Freidlin, B, Hu, C, and Korn, EL (2021) Are restricted mean survival time methods especially useful for Noninferiority Trials? Clinical Trials 18:188-196

Dodd LE, Freidlin B, and Korn EL (2021). Platform trials - Beware the noncomparable control group. New England Journal of Medicine 384:1572-1573.

Freidlin B and Korn EL. (2022) A problematic trial design. Journal of the National Cancer Institute 114:187-190

Korn EL and Freidlin B. (2022) Time trends with response adaptive randomization: the inevitability of inefficiency. Clinical Trials 19: 58-161.

Korn EL, Allegra CJ, and Freidlin B. (2022). Clinical benefit scales and trial design: some statistical issues. Journal of the National Cancer Institute 114:1222-1227.

Freidlin B and Korn EL. (2023) Augmenting randomized clinical trial data with historical control data: Precision medicine applications. Journal of the National Cancer Institute 115:14-20.

Korn EL, Moscow JA, and Freidlin B. (2022) Dose optimization during drug development: whether and when to optimize. Journal of the National Cancer Institute (in press, available online)