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Dr. Boris Freidlin

Branch Chief, Biostatistics Branch

Biosketch

Dr. Freidlin has been a statistician with the National Cancer Institute since 1998. He was appointed chief of the Biostatistics Branch in 2019. Before coming to the NCI, he worked for the Emmes Corporation and the George Washington University Biostatistics Center. Dr. Freidlin holds a BS degree in mathematics from the University of Maryland and a PhD degree in statistics from the George Washington University. His research interests include design and analysis of adaptive clinical trials and methodologies for evaluation of new cancer treatments and companion biomarkers. Dr. Freidlin is co-author of over 100 publications. He is currently on the data safety and monitoring board for the Children's Oncology Group. Dr. Freidlin is an Associate Editor of Clinical Trials. He serves on the NCI Myeloma, Lymphoma, Leukemia Steering Committees and on the NCI Pediatric Leukemia & Lymphoma and Pediatric Solid Tumor Steering Committees.

CV (Updated January 2024)

Selected Publications:

Simon R, Freidlin B, Rubinstein L, Arbuck S, Collins J, Christian M. Accelerated Titration Designs for Phase I Clinical Trials in Oncology. Journal of the National Cancer Institute 89, 1138-1147, 1997.

Freidlin B, Gastwirth, JL. Unconditional Versions of Several Tests Commonly Used in the Analysis of Contingency Tables. Biometrics 55, 84-89. 1999.

Freidlin B, Podgor MJ, Gastwirth JL. Efficiency Robust Tests for Survival and Ordered Categorical Data. Biometrics 55, 883-886, 1999.

Freidlin B, Korn EL and George SL. Data monitoring committees and interim monitoring guidelines. Controlled Clinical Trials 20, 395-407, 1999.

Freidlin B, and Gastwirth JL. Should the median test be retired from the general use? American Statistician 54, 161-164, 2000.

Freidlin B and Korn EL A testing procedure for survival data with few responders. Statistics in Medicine 21, 65-78, 2002.

Freidlin B and Korn EL A comment on futility monitoring. Controlled Clinical Trials 23, 355-356, 2002.

Freidlin B, Zheng G, Li Z, Gastwirth JL. Trend tests for case-control studies of genetic markers: power, sample size and robustness. Human Heredity, 53 146-152, 2002.

Freidlin B, Korn EL. Testing treatment effects in the presence of competing risks. Statistics in Medicine 24, 1703-1712, 2005.

Freidlin B, Simon R. Adaptive signature design: An adaptive clinical trial design for generating and prospectively testing a gene expression signature for sensitive patients. Clinical Cancer Research 11:7872-7878. 2005.

Korn EL, Freidlin B. Conditional power calculations for clinical trials with historical controls. Statistics in Medicine 25:2922-2931, 2006.

Freidlin B, Korn EL, Hunsberger S, Gray R, Saxman S, Zujewski JA. Proposal for the use of progression-free survival in unblinded randomized trials. Journal of Clinical Oncology 25:2122-6, 2007.

Jiang W, Freidlin B, Simon R. Biomarker-adaptive threshold design: a procedure for evaluating treatment with possible biomarker-defined subset effect. Journal of the National Cancer Institute 99:1036-43, 2007.

Freidlin B, Korn EL, George SL, Gray R. Randomized clinical trial design for assessing non-inferiority when superiority is expected. Journal of Clinical Oncology 25: 5019-5023, 2007.

Freidlin B, Korn EL, Gray R, Martin A. Multi-arm clinical trials of new agents: some design considerations. Clinical Cancer Research 14:4368-71, 2008

Freidlin B, Korn EL. Stopping clinical trials early for benefit: impact on estimation. Clinical Trials 6:119-25, 2009.

Freidlin B, Jiang W, Simon R. The cross-validated adaptive signature design. Clinical Cancer Research 16:691-8, 2010

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

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

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, 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, Korn EL. Borrowing Information Across Subgroups: Is It Useful? Clinical Cancer Research 19:1326-1334, 2013

Freidlin B, Korn EL. Adaptive randomization versus interim Monitoring. Journal of Clinical Oncology 31:969-970, 2013

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, Sun Z, Gray R, Korn EL. Phase III clinical trials that integrate treatment and biomarker evaluation. Journal of Clinical Oncology 31: 3158-3161, 2013

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

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

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.

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

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

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

Freidlin B, Korn EL, Abrams JS. Bias, operational bias, and generalizability in phase II/III trials. Journal of Clinical Oncology 36:1902-04, 2018.

Korn EL, Freidlin B. Interim futility monitoring assessing immune therapies with a potentially delayed treatment effect. Journal of Clinical Oncology 36:2444-49, 2018.

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

Freidlin B, Korn EL. Methods for Accommodating Nonproportional Hazards in Clinical Trials: Ready for the Primary Analysis? Journal of Clinical Oncology 37:3455-3459, 2019.

Freidlin B, Allegra CJ, Korn EL. Moving Molecular Profiling to Routine Clinical Practice: A Way Forward? Journal of the National Cancer Institute 112:djz240, 2020.

Freidlin B, Hu, C, Korn EL. Are restricted mean survival time methods especially useful for noninferiority trials? Clinical Trials doi.org/10.1177/1740774520976576, 2021.

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

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

Korn EL and Freidlin B. Time trends with response adaptive randomization: the inevitability of inefficiency. Clinical Trials 2022, doi.org/10.1177/17407745211065762

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

Freidlin B and Korn EL. Augmenting randomized clinical trial data with historical control data: Precision medicine applications. Journal of the National Cancer Institute 115(1):14-20, 2023

LoRusso PM, Freidlin B. Improving Precision Oncology through Better Designs and Reporting of Biomarker-Driven Randomized Clinical Trials. Journal of the National Cancer Institute 115(2): 122-124, 2023

Korn EL, Moscow JA, and Freidlin B. Dose optimization during drug development: whether and when to optimize. Journal of the National Cancer Institute 115(5): 492-497, 2023

Freidlin B, Korde LA, and Korn EL. Timing and reporting of secondary overall survival end points for phase III trials in advanced/metastatic disease. Journal of Clinical Oncology 41:4616-4620, 2023

Zhao Y, Yuan Y, Korn EL, and Freidlin B. Backfilling patients in phase I dose escalation trials using BOIN. Clinical Cancer Research (in press)