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Biometric Research Program (BRP)

Dr. Boris Freidlin

Branch Chief, Biostatistics Branch


Research Interests

Design and analysis of clinical trials, evaluation of new cancer treatments and companion biomarkers.


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.

Smith M, Freidlin B, Gloeckler Reis LA, and Simon R. Trends in the Reported Incidence of Primary Malignant Brain Tumors in Children in the United States. Journal of the National Cancer Institute 90, 1269-1277, 1998.

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, Zheng G, Li ZH, Gastwirth JL. Efficiency robust tests for mapping quantitative trait loci using extremely discordant sib pairs. Human Heredity 55, 117-124, 2003.

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

Freidlin B, Simon R. An evaluation of randomized discontinuation design. Journal of Clinical Oncology 23, 5094-5098. 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. Release of data from an ongoing randomized clinical trial for sample size adjustment or planning. Statistics in Medicine 26:4074-4082, 2007.

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.

Korn EL and Freidlin B. A note on controlling the number of false positives. Biometrics 64:227-231, 2008.

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

Dodd LE, Korn EL, Freidlin B, Jaffe CC, Rubinstein LV, Dancey J, Mooney MM. Blinded independent central review of progression-free survival in phase III clinical trials: important design element or unnecessary expense? Journal of Clinical Oncology 26:3791-6, 2008.

Freidlin B, Korn EL. Monitoring for Lack of Benefit: A Critical Component of a Randomized Clinical Trial. Journal of Clinical Oncology 27:629-33, 2009.

Korn EL, Freidlin B, Mooney M. Stopping or Reporting Early for Positive Results in Randomized Clinical Trials: The NCI Cooperative Group Experience 1990-2005. Journal of Clinical Oncology 27:1543-4, 2009.

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

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, Dodd LE, and Freidlin B (2010). Measurement error in the timing of events: effect on survival analyses in randomized clinical trials. Clinical Trials 7, 626-633.

Korn EL, Freidlin B, Mooney M, and Abrams JS (2010). Accrual experience of NCI cooperative group phase III trials activated in 2000-2007. Journal of Clinical Oncology 28, 5197-5201.

Freidlin B and Korn EL (2010). Biomarker-adaptive clinical trial designs. Pharmacogenomics 11, 1679-1682.

Freidlin B, Jiang W, Simon R. (2010). The cross-validated adaptive signature design. Clin Cancer Res. 16:691-8

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 and Korn EL (2012). Assessing causal relationships between treatments and clinical outcomes: always read the fine print. Bone Marrow Transplantation 47, 626-632.

Korn EL and Freidlin B (2012). Methodology for comparative effectiveness research: potential and limitations. Journal of Clinical Oncology 34, 4185-4187.

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, Abrams JS, and Korn EL (2013). New challenges for comparative effectiveness in oncology: choice of primary endpoint for randomized clinical trials. Journal of Comparative Effectiveness Research 2, 469-481.

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.

Freidlin B and Korn, EL (2014). A model too far. Journal of the National Cancer Institute 106 (2), djt368 doi:10.1093/jnci/djt368.

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.

Korn EL and Freidlin B (2015). Evaluation of chemoresponse assays as predictive markers. British Journal of Cancer 112, 621-623.

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 and Freidlin B (2016). Non-factorial analyses of two-by-two factorial trial designs. Clinical Trials (in press).

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 (in press)



Dr. Boris Freidlin

Office Address:
Room 5W102
9609 Medical Center Dr
Rockville, MD 20850

Contact Information:
Tel: (240) 276-6024
Fax: (240) 276-7888
Email:freidlinb@ctep.nci.nih.gov