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Items: 1 to 50 of 191

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.

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
8.

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
9.

A retrospective study of Class II mixed-dentition treatment.

Oh H, Baumrind S, Korn EL, Dugoni S, Boero R, Aubert M, Boyd R.

Angle Orthod. 2017 Jan;87(1):56-67. doi: 10.2319/012616-72.1. Epub 2016 Jul 8.

PMID:
27391205
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.
16.

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.

17.

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.

18.

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
19.

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.

20.

Consensus report of a joint NCI thoracic malignancies steering committee: FDA workshop on strategies for integrating biomarkers into clinical development of new therapies for lung cancer leading to the inception of "master protocols" in lung cancer.

Malik SM, Pazdur R, Abrams JS, Socinski MA, Sause WT, Harpole DH Jr, Welch JJ, Korn EL, Ullmann CD, Hirsch FR.

J Thorac Oncol. 2014 Oct;9(10):1443-8. doi: 10.1097/JTO.0000000000000314.

21.

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.

22.

Decade in review--clinical trials: shifting paradigms in cancer clinical trial design.

Sargent DJ, Korn EL.

Nat Rev Clin Oncol. 2014 Nov;11(11):625-6. doi: 10.1038/nrclinonc.2014.167. Epub 2014 Oct 7. No abstract available.

PMID:
25286977
23.

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
24.

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.

25.

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
26.

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.

27.

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
28.

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
29.

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.

30.

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
31.

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
32.

Implementation of timeline reforms speeds initiation of National Cancer Institute-sponsored trials.

Abrams JS, Mooney MM, Zwiebel JA, Korn EL, Friedman SH, Finnigan SR, Schettino PR, Denicoff AM, Kruhm MG, Montello M, Misra RR, Ansher SS, DiPiazza KJ, Souhan EM, Wickerham DL, Giantonio BJ, O'Donnell RT, Sullivan DM, Soto NI, Fleming GF, Prindiville SA, Petryshyn RA, Hautala JA, Grad O, Zuckerman BL, Meyer RM, Yao JC, Baker LA, Buckner JC, Hortobagyi GN, Doroshow JH.

J Natl Cancer Inst. 2013 Jul 3;105(13):954-9. doi: 10.1093/jnci/djt137. Epub 2013 Jun 17.

33.

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.

34.

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.

35.

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
36.

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.

37.

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
38.

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.

39.

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
40.

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.

41.

Discussion of the paper of Ghosh, Taylor, and Sargent.

Korn EL.

Biometrics. 2012 Mar;68(1):236-8; discussion 245-7. doi: 10.1111/j.1541-0420.2011.01635.x. Epub 2011 Jun 13. No abstract available.

PMID:
21668901
42.

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
43.

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.

44.

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
45.

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.

46.

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.

47.

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.

48.

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.

49.

Randomized clinical trial comparing control of maxillary anchorage with 2 retraction techniques.

Xu TM, Zhang X, Oh HS, Boyd RL, Korn EL, Baumrind S.

Am J Orthod Dentofacial Orthop. 2010 Nov;138(5):544.e1-9; discussion 544-5. doi: 10.1016/j.ajodo.2009.12.027.

PMID:
21055588
50.

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

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