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Items: 1 to 50 of 105

1.

Surrogate and Intermediate Endpoints in Randomized Trials: What's the Goal?

Korn EL, Freidlin B.

Clin Cancer Res. 2018 Feb 12. pii: clincanres.0183.2018. doi: 10.1158/1078-0432.CCR-18-0183. [Epub ahead of print]

PMID:
29440189
2.

Interim monitoring for non-inferiority trials: minimizing patient exposure to inferior therapies.

Korn EL, Freidlin B.

Ann Oncol. 2017 Dec 18. doi: 10.1093/annonc/mdx788. [Epub ahead of print]

PMID:
29267937
3.

Quantitative assessment of a prognostic or predictive biomarker panel.

Korn EL, Freidlin B.

J Biopharm Stat. 2017 Oct 30:1-18. doi: 10.1080/10543406.2017.1378665. [Epub ahead of print]

PMID:
29083961
4.

Two-by-Two Factorial Cancer Treatment Trials: Is Sufficient Attention Being Paid to Possible Interactions?

Freidlin B, Korn EL.

J Natl Cancer Inst. 2017 Sep 1;109(9). doi: 10.1093/jnci/djx146. Review.

PMID:
28954288
5.

Sample size adjustment designs with time-to-event outcomes: A caution.

Freidlin B, Korn EL.

Clin Trials. 2017 Dec;14(6):597-604. doi: 10.1177/1740774517724746. Epub 2017 Aug 10.

PMID:
28795844
6.

Rejoinder.

Freidlin B, Korn EL.

Clin Trials. 2017 Dec;14(6):609-610. doi: 10.1177/1740774517724748. Epub 2017 Aug 4. No abstract available.

PMID:
28776409
7.

Myeloma Minimal Residual Disease and Surrogacy.

Little RF, McShane LM, Freidlin B.

JAMA Oncol. 2017 Aug 1;3(8):1136. doi: 10.1001/jamaoncol.2016.5660. No abstract available.

PMID:
28494064
8.

Assessing treatment efficacy in the subset of responders in a randomized clinical trial.

Korn EL, Othus M, Chen T, Freidlin B.

Ann Oncol. 2017 Jul 1;28(7):1640-1647. doi: 10.1093/annonc/mdx197.

PMID:
28444115
9.

Adaptive Clinical Trials: Advantages and Disadvantages of Various Adaptive Design Elements.

Korn EL, Freidlin B.

J Natl Cancer Inst. 2017 Jun 1;109(6). doi: 10.1093/jnci/djx013.

PMID:
28376148
10.

Reader reaction on estimation of treatment effects in all-comers randomized clinical trials with a predictive marker.

Korn EL, Freidlin B.

Biometrics. 2017 Jun;73(2):706-708. doi: 10.1111/biom.12592. Epub 2016 Oct 24.

PMID:
27775815
11.

Comparison of futility monitoring guidelines using completed phase III oncology trials.

Zhang Q, Freidlin B, Korn EL, Halabi S, Mandrekar S, Dignam JJ.

Clin Trials. 2017 Feb;14(1):48-58. doi: 10.1177/1740774516666502. Epub 2016 Sep 22.

12.

Non-factorial analyses of two-by-two factorial trial designs.

Korn EL, Freidlin B.

Clin Trials. 2016 Dec;13(6):651-659. Epub 2016 Jul 19.

PMID:
27439306
13.

Information time scales for interim analyses of randomized clinical trials.

Freidlin B, Othus M, Korn EL.

Clin Trials. 2016 Aug;13(4):391-9. doi: 10.1177/1740774516644752. Epub 2016 May 2.

PMID:
27136947
14.

RE: Impact of a Biomarker-Based Strategy on Oncology Drug Development: A Meta-analysis of Clinical Trials Leading to FDA Approval.

Freidlin B, Korn EL.

J Natl Cancer Inst. 2016 Feb 24;108(3):djv430. doi: 10.1093/jnci/djv430. Print 2016 Mar. No abstract available.

15.

Design Issues in Randomized Clinical Trials of Maintenance Therapies.

Freidlin B, Little RF, Korn EL.

J Natl Cancer Inst. 2015 Aug 18;107(11). pii: djv225. doi: 10.1093/jnci/djv225. Print 2015 Nov.

16.

Response to comment on: 'evaluation of chemoresponse assays as predictive biomarkers'.

Korn EL, Freidlin B.

Br J Cancer. 2015 Jun 9;112(12):1978. doi: 10.1038/bjc.2015.157. Epub 2015 May 12. No abstract available.

17.

Commentary on Hey and Kimmelman.

Korn EL, Freidlin B.

Clin Trials. 2015 Apr;12(2):122-4. doi: 10.1177/1740774515569611. Epub 2015 Feb 3. No abstract available.

PMID:
25649108
18.

Evaluation of chemoresponse assays as predictive markers.

Korn EL, Freidlin B.

Br J Cancer. 2015 Feb 17;112(4):621-3. doi: 10.1038/bjc.2014.661. Epub 2015 Jan 13.

19.

Assessing treatment benefit with competing risks not affected by the randomized treatment.

Korn EL, Dignam JJ, Freidlin B.

Stat Med. 2015 Jan 30;34(2):265-80. doi: 10.1002/sim.6353. Epub 2014 Nov 3.

20.

Two-stage adaptive cutoff design for building and validating a prognostic biomarker signature.

Polley MY, Polley EC, Huang EP, Freidlin B, Simon R.

Stat Med. 2014 Dec 20;33(29):5097-110. doi: 10.1002/sim.6310. Epub 2014 Sep 28.

21.

Transparency in interim monitoring.

Freidlin B, Korn EL.

J Clin Oncol. 2014 Aug 1;32(22):2387-8. doi: 10.1200/JCO.2014.55.3016. Epub 2014 Jun 30. No abstract available.

PMID:
24982465
22.

Response.

Freidlin B, Korn EL.

J Natl Cancer Inst. 2014 Apr;106(4):dju059. doi: 10.1093/jnci/dju059. Epub 2014 Mar 21. No abstract available.

23.

Reply to S. Goteti et al.

Freidlin B, Sun Z, Gray R, Korn EL.

J Clin Oncol. 2014 Mar 10;32(8):856. doi: 10.1200/JCO.2013.53.8934. Epub 2014 Feb 3. No abstract available.

PMID:
24493728
24.

A model too far.

Freidlin B, Korn EL.

J Natl Cancer Inst. 2014 Feb;106(2):djt368. doi: 10.1093/jnci/djt368. Epub 2014 Jan 7. No abstract available.

25.

Biomarker enrichment strategies: matching trial design to biomarker credentials.

Freidlin B, Korn EL.

Nat Rev Clin Oncol. 2014 Feb;11(2):81-90. doi: 10.1038/nrclinonc.2013.218. Epub 2013 Nov 26. Review.

PMID:
24281059
26.

New challenges for comparative effectiveness in oncology: choice of primary end points for randomized clinical trials.

Freidlin B, Abrams JS, Korn EL.

J Comp Eff Res. 2013 Sep;2(5):469-81. doi: 10.2217/cer.13.50. Review.

PMID:
24236744
27.

Statistical and practical considerations for clinical evaluation of predictive biomarkers.

Polley MY, Freidlin B, Korn EL, Conley BA, Abrams JS, McShane LM.

J Natl Cancer Inst. 2013 Nov 20;105(22):1677-83. doi: 10.1093/jnci/djt282. Epub 2013 Oct 17.

28.

Marker Sequential Test (MaST) design.

Freidlin B, Korn EL, Gray R.

Clin Trials. 2014 Feb;11(1):19-27. doi: 10.1177/1740774513503739. Epub 2013 Oct 1.

PMID:
24085774
29.

An audit strategy for time-to-event outcomes measured with error: application to five randomized controlled trials in oncology.

Dodd LE, Korn EL, Freidlin B, Gu W, Abrams JS, Bushnell WD, Canetta R, Doroshow JH, Gray RJ, Sridhara R.

Clin Trials. 2013 Oct;10(5):754-60. doi: 10.1177/1740774513493973. Epub 2013 Aug 9.

PMID:
23935162
30.

Phase III clinical trials that integrate treatment and biomarker evaluation.

Freidlin B, Sun Z, Gray R, Korn EL.

J Clin Oncol. 2013 Sep 1;31(25):3158-61. doi: 10.1200/JCO.2012.48.3826. Epub 2013 Apr 8. No abstract available.

31.

Statistical challenges in the evaluation of treatments for small patient populations.

Korn EL, McShane LM, Freidlin B.

Sci Transl Med. 2013 Mar 27;5(178):178sr3. doi: 10.1126/scitranslmed.3004018. Review.

32.

Adaptive randomization versus interim monitoring.

Freidlin B, Korn EL.

J Clin Oncol. 2013 Mar 1;31(7):969-70. doi: 10.1200/JCO.2012.45.0254. Epub 2013 Jan 22. No abstract available.

PMID:
23341515
33.

Borrowing information across subgroups in phase II trials: is it useful?

Freidlin B, Korn EL.

Clin Cancer Res. 2013 Mar 15;19(6):1326-34. doi: 10.1158/1078-0432.CCR-12-1223. Epub 2013 Jan 9.

34.

NCI-RTOG translational program strategic guidelines for the early-stage development of radiosensitizers.

Lawrence YR, Vikram B, Dignam JJ, Chakravarti A, Machtay M, Freidlin B, Takebe N, Curran WJ Jr, Bentzen SM, Okunieff P, Coleman CN, Dicker AP.

J Natl Cancer Inst. 2013 Jan 2;105(1):11-24. doi: 10.1093/jnci/djs472. Epub 2012 Dec 10.

35.

Methodology for comparative effectiveness research: potential and limitations.

Korn EL, Freidlin B.

J Clin Oncol. 2012 Dec 1;30(34):4185-7. doi: 10.1200/JCO.2012.44.8233. Epub 2012 Oct 15. No abstract available.

PMID:
23071226
36.

Randomized phase II trial designs with biomarkers.

Freidlin B, McShane LM, Polley MY, Korn EL.

J Clin Oncol. 2012 Sep 10;30(26):3304-9. doi: 10.1200/JCO.2012.43.3946. Epub 2012 Aug 6.

37.

Bevacizumab in ovarian cancer.

Korn EL, Freidlin B, Abrams JS.

N Engl J Med. 2012 Mar 29;366(13):1256; author reply 1257-8. doi: 10.1056/NEJMc1201044#SA1. No abstract available.

PMID:
22455428
38.

Design issues in randomized phase II/III trials.

Korn EL, Freidlin B, Abrams JS, Halabi S.

J Clin Oncol. 2012 Feb 20;30(6):667-71. doi: 10.1200/JCO.2011.38.5732. Epub 2012 Jan 23.

39.

Assessing causal relationships between treatments and clinical outcomes: always read the fine print.

Freidlin B, Korn EL.

Bone Marrow Transplant. 2012 May;47(5):626-32. doi: 10.1038/bmt.2011.119. Epub 2011 May 30. Review.

PMID:
21625225
40.

Overall survival as the outcome for randomized clinical trials with effective subsequent therapies.

Korn EL, Freidlin B, Abrams JS.

J Clin Oncol. 2011 Jun 10;29(17):2439-42. doi: 10.1200/JCO.2011.34.6056. Epub 2011 May 9. Review.

41.

Inefficacy interim monitoring procedures in randomized clinical trials: the need to report.

Korn EL, Freidlin B.

Am J Bioeth. 2011 Mar;11(3):2-10. doi: 10.1080/15265161.2010.546471.

PMID:
21400374
42.

Re: Designing a randomized clinical trial to evaluate personalized medicine: a new approach based on risk prediction.

Simon RM, Freidlin B.

J Natl Cancer Inst. 2011 Mar 2;103(5):445; author reply 445-6, discussion 446. doi: 10.1093/jnci/djq552. Epub 2011 Jan 12. No abstract available.

PMID:
21228315
43.

An audit strategy for progression-free survival.

Dodd LE, Korn EL, Freidlin B, Gray R, Bhattacharya S.

Biometrics. 2011 Sep;67(3):1092-9. doi: 10.1111/j.1541-0420.2010.01539.x. Epub 2011 Jan 6.

44.

Outcome--adaptive randomization: is it useful?

Korn EL, Freidlin B.

J Clin Oncol. 2011 Feb 20;29(6):771-6. doi: 10.1200/JCO.2010.31.1423. Epub 2010 Dec 20.

45.

Biomarker-adaptive clinical trial designs.

Freidlin B, Korn EL.

Pharmacogenomics. 2010 Dec;11(12):1679-82. doi: 10.2217/pgs.10.153. No abstract available.

46.

Accrual experience of National Cancer Institute Cooperative Group phase III trials activated from 2000 to 2007.

Korn EL, Freidlin B, Mooney M, Abrams JS.

J Clin Oncol. 2010 Dec 10;28(35):5197-201. doi: 10.1200/JCO.2010.31.5382. Epub 2010 Nov 8.

47.

Measurement error in the timing of events: effect on survival analyses in randomized clinical trials.

Korn EL, Dodd LE, Freidlin B.

Clin Trials. 2010 Dec;7(6):626-33. doi: 10.1177/1740774510382801. Epub 2010 Sep 6.

PMID:
20819840
48.

Causal inference for definitive clinical end points in a randomized clinical trial with intervening nonrandomized treatments.

Korn EL, Freidlin B.

J Clin Oncol. 2010 Aug 20;28(24):3800-2. doi: 10.1200/JCO.2010.30.0442. Epub 2010 Jul 26. No abstract available.

PMID:
20660828
49.

Bias and trials stopped early for benefit.

Korn EL, Freidlin B, Mooney M.

JAMA. 2010 Jul 14;304(2):157-8; author reply 158-9. doi: 10.1001/jama.2010.932. No abstract available.

PMID:
20628125
50.

A general inefficacy interim monitoring rule for randomized clinical trials.

Freidlin B, Korn EL, Gray R.

Clin Trials. 2010 Jun;7(3):197-208. doi: 10.1177/1740774510369019. Epub 2010 Apr 27.

PMID:
20423925

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