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Validation of biomarkers to predict response to immunotherapy in cancer: Volume II - clinical validation and regulatory considerations.

Dobbin KK, Cesano A, Alvarez J, Hawtin R, Janetzki S, Kirsch I, Masucci GV, Robbins PB, Selvan SR, Streicher HZ, Zhang J, Butterfield LH, Thurin M.

J Immunother Cancer. 2016 Nov 15;4:77. Review.


Future perspectives in melanoma research : Meeting report from the "Melanoma Bridge". Napoli, December 1st-4th 2015.

Ascierto PA, Agarwala S, Botti G, Cesano A, Ciliberto G, Davies MA, Demaria S, Dummer R, Eggermont AM, Ferrone S, Fu YX, Gajewski TF, Garbe C, Huber V, Khleif S, Krauthammer M, Lo RS, Masucci G, Palmieri G, Postow M, Puzanov I, Silk A, Spranger S, Stroncek DF, Tarhini A, Taube JM, Testori A, Wang E, Wargo JA, Yee C, Zarour H, Zitvogel L, Fox BA, Mozzillo N, Marincola FM, Thurin M.

J Transl Med. 2016 Nov 15;14(1):313.


Optimal sequential enrichment designs for phase II clinical trials.

Zang Y, Yuan Y.

Stat Med. 2017 Jan 15;36(1):54-66. doi: 10.1002/sim.7128.


Bayesian Two-stage Biomarker-based Adaptive Design for Targeted Therapy Development.

Gu X, Chen N, Wei C, Liu S, Papadimitrakopoulou VA, Herbst RS, Lee JJ.

Stat Biosci. 2016 Jun;8(1):99-128.


Precision oncology: A new era of cancer clinical trials.

Renfro LA, An MW, Mandrekar SJ.

Cancer Lett. 2017 Feb 28;387:121-126. doi: 10.1016/j.canlet.2016.03.015.


Optimal marker-strategy clinical trial design to detect predictive markers for targeted therapy.

Zang Y, Liu S, Yuan Y.

Biostatistics. 2016 Jul;17(3):549-60. doi: 10.1093/biostatistics/kxw006.


Biomarker-Guided Adaptive Trial Designs in Phase II and Phase III: A Methodological Review.

Antoniou M, Jorgensen AL, Kolamunnage-Dona R.

PLoS One. 2016 Feb 24;11(2):e0149803. doi: 10.1371/journal.pone.0149803. Review.


Clinical trial designs incorporating predictive biomarkers.

Renfro LA, Mallick H, An MW, Sargent DJ, Mandrekar SJ.

Cancer Treat Rev. 2016 Feb;43:74-82. doi: 10.1016/j.ctrv.2015.12.008. Review.


Lung cancer biomarkers, targeted therapies and clinical assays.

Patel JN, Ersek JL, Kim ES.

Transl Lung Cancer Res. 2015 Oct;4(5):503-14. doi: 10.3978/j.issn.2218-6751.2015.06.02. Review.


Molecular and clinical implementations of ovarian cancer mouse avatar models.

Zayed AA, Mandrekar SJ, Haluska P.

Chin Clin Oncol. 2015 Sep;4(3):30. doi: 10.3978/j.issn.2304-3865.2015.04.01. Review.


Clinical Neuropathology practice guide 5-2015: MGMT methylation pyrosequencing in glioblastoma: unresolved issues and open questions.

Bienkowski M, Berghoff AS, Marosi C, Wöhrer A, Heinzl H, Hainfellner JA, Preusser M.

Clin Neuropathol. 2015 Sep-Oct;34(5):250-7. Review.


Actionable pharmacogenetic markers for prediction and prognosis in breast cancer.

Sacco K, Grech G.

EPMA J. 2015 Jul 22;6(1):15. doi: 10.1186/s13167-015-0037-z.


Clinical Translation and Validation of a Predictive Biomarker for Patritumab, an Anti-human Epidermal Growth Factor Receptor 3 (HER3) Monoclonal Antibody, in Patients With Advanced Non-small Cell Lung Cancer.

Mendell J, Freeman DJ, Feng W, Hettmann T, Schneider M, Blum S, Ruhe J, Bange J, Nakamaru K, Chen S, Tsuchihashi Z, von Pawel J, Copigneaux C, Beckman RA.

EBioMedicine. 2015 Feb 12;2(3):264-71. doi: 10.1016/j.ebiom.2015.02.005.


Designing a study to evaluate the benefit of a biomarker for selecting patient treatment.

Janes H, Brown MD, Pepe MS.

Stat Med. 2015 Nov 30;34(27):3503-15. doi: 10.1002/sim.6564.


Genotype-based clinical trials in cardiovascular disease.

Pereira NL, Sargent DJ, Farkouh ME, Rihal CS.

Nat Rev Cardiol. 2015 Aug;12(8):475-87. doi: 10.1038/nrcardio.2015.64. Review.


Adaptive clinical trial designs in oncology.

Zang Y, Lee JJ.

Chin Clin Oncol. 2014 Dec;3(4). pii: 49.


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.


Methods and challenges in quantitative imaging biomarker development.

Abramson RG, Burton KR, Yu JP, Scalzetti EM, Yankeelov TE, Rosenkrantz AB, Mendiratta-Lala M, Bartholmai BJ, Ganeshan D, Lenchik L, Subramaniam RM.

Acad Radiol. 2015 Jan;22(1):25-32. doi: 10.1016/j.acra.2014.09.001. Review.


Adaptive designs for subpopulation analysis optimizing utility functions.

Graf AC, Posch M, Koenig F.

Biom J. 2015 Jan;57(1):76-89. doi: 10.1002/bimj.201300257.

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