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Adding experimental arms to platform clinical trials: randomization procedures and interim analyses.

Ventz S, Cellamare M, Parmigiani G, Trippa L.

Biostatistics. 2018 Apr 1;19(2):199-215. doi: 10.1093/biostatistics/kxx030.


Challenges and Opportunities in Adapting Clinical Trial Design for Immunotherapies.

Siu LL, Ivy SP, Dixon EL, Gravell AE, Reeves SA, Rosner GL.

Clin Cancer Res. 2017 Sep 1;23(17):4950-4958. doi: 10.1158/1078-0432.CCR-16-3079.


Adaptive Clinical Trials: Overview of Early-Phase Designs and Challenges.

Marchenko O, Fedorov V, Lee JJ, Nolan C, Pinheiro J.

Ther Innov Regul Sci. 2014 Jan;48(1):20-30. doi: 10.1177/2168479013513889. Epub 2013 Nov 26.


Breast cancers are rare diseases-and must be treated as such.

Bartlett JMS, Parelukar W.

NPJ Breast Cancer. 2017 Apr 11;3:11. doi: 10.1038/s41523-017-0013-y. eCollection 2017. No abstract available.


Spotlight on landmark oncology trials: the latest evidence and novel trial designs.

Earl H, Molica S, Rutkowski P.

BMC Med. 2017 Jun 2;15(1):111. doi: 10.1186/s12916-017-0884-7.


Interim heterogeneity changes measured using entropy texture features on T2-weighted MRI at 3.0 T are associated with pathological response to neoadjuvant chemotherapy in primary breast cancer.

Henderson S, Purdie C, Michie C, Evans A, Lerski R, Johnston M, Vinnicombe S, Thompson AM.

Eur Radiol. 2017 Nov;27(11):4602-4611. doi: 10.1007/s00330-017-4850-8. Epub 2017 May 18.


Toil enables reproducible, open source, big biomedical data analyses.

Vivian J, Rao AA, Nothaft FA, Ketchum C, Armstrong J, Novak A, Pfeil J, Narkizian J, Deran AD, Musselman-Brown A, Schmidt H, Amstutz P, Craft B, Goldman M, Rosenbloom K, Cline M, O'Connor B, Hanna M, Birger C, Kent WJ, Patterson DA, Joseph AD, Zhu J, Zaranek S, Getz G, Haussler D, Paten B.

Nat Biotechnol. 2017 Apr 11;35(4):314-316. doi: 10.1038/nbt.3772. No abstract available.


Point/counterpoint: randomized versus single-arm phase II clinical trials for patients with newly diagnosed glioblastoma.

Grossman SA, Schreck KC, Ballman K, Alexander B.

Neuro Oncol. 2017 Apr 1;19(4):469-474. doi: 10.1093/neuonc/nox030. No abstract available.


Advancing Diagnostics to Address Antibacterial Resistance: The Diagnostics and Devices Committee of the Antibacterial Resistance Leadership Group.

Tsalik EL, Petzold E, Kreiswirth BN, Bonomo RA, Banerjee R, Lautenbach E, Evans SR, Hanson KE, Klausner JD, Patel R; and the Diagnostics and Devices Committee; of the Antibacterial Resistance Leadership Group.

Clin Infect Dis. 2017 Mar 15;64(suppl_1):S41-S47. doi: 10.1093/cid/ciw831. Review.


Leveraging molecular datasets for biomarker-based clinical trial design in glioblastoma.

Tanguturi SK, Trippa L, Ramkissoon SH, Pelton K, Knoff D, Sandak D, Lindeman NI, Ligon AH, Beroukhim R, Parmigiani G, Wen PY, Ligon KL, Alexander BM.

Neuro Oncol. 2017 Jul 1;19(7):908-917. doi: 10.1093/neuonc/now312.


Toward Personalized Targeted Therapeutics: An Overview.

Weathers SS, Gilbert MR.

Neurotherapeutics. 2017 Apr;14(2):256-264. doi: 10.1007/s13311-016-0496-5. Review.


The Importance of Biopsy in the Era of Molecular Medicine.

Ziv E, Durack JC, Solomon SB.

Cancer J. 2016 Nov/Dec;22(6):418-422. Review.


A response-adaptive design of initial therapy for emergency department patients with heart failure.

Wen S, Ning J, Collins S, Berry D.

Contemp Clin Trials. 2017 Jan;52:46-53. doi: 10.1016/j.cct.2016.11.002. Epub 2016 Nov 9.


Prognostic factors of successful on-purpose tumor biopsies in metastatic cancer patients included in the SHIVA prospective clinical trial.

Desportes E, Wagner M, Kamal M, Salomon AV, Deniziaut G, Pierron G, Rouleau E, Jouffroy T, Le Tourneau C, Paoletti X, Servois V.

Oncotarget. 2017 Jan 3;8(1):1760-1773. doi: 10.18632/oncotarget.12051.


PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms.

Trusheim MR, Shrier AA, Antonijevic Z, Beckman RA, Campbell RK, Chen C, Flaherty KT, Loewy J, Lacombe D, Madhavan S, Selker HP, Esserman LJ.

Clin Pharmacol Ther. 2016 Dec;100(6):713-729. doi: 10.1002/cpt.514. Epub 2016 Oct 19.


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. Epub 2016 Sep 19.


Adaptive Biomedical Innovation: Evolving Our Global System to Sustainably and Safely Bring New Medicines to Patients in Need.

Hirsch G, Trusheim M, Cobbs E, Bala M, Garner S, Hartman D, Isaacs K, Lumpkin M, Lim R, Oye K, Pezalla E, Saltonstall P, Selker H.

Clin Pharmacol Ther. 2016 Dec;100(6):685-698. doi: 10.1002/cpt.509. Epub 2016 Oct 22. Erratum in: Clin Pharmacol Ther. 2017 Apr;101(4):542.


Subgroup-Based Adaptive (SUBA) Designs for Multi-Arm Biomarker Trials.

Xu Y, Trippa L, Müller P, Ji Y.

Stat Biosci. 2016 Jun;8(1):159-180. Epub 2014 Jul 17.


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. Epub 2014 Dec 4.

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