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Lung Cancer-Related Mortality With Inhaled Insulin or a Comparator: Follow-Up Study of patients previously enrolled in Exubera Controlled Clinical Trials (FUSE) Final Results.

Gatto NM, Koralek DO, Bracken MB, Duggan WT, Lem J, Klioze S, Koch GG, Wise RA, Cohen RB, Jackson NC.

Diabetes Care. 2019 Sep;42(9):1708-1715. doi: 10.2337/dc18-2529. Epub 2019 Jul 22.


Randomization-based analysis of covariance for inference in the sequential parallel comparison design.

Wiener LE, Ivanova A, Li S, Silverman RK, Koch GG.

J Biopharm Stat. 2019;29(4):696-713. doi: 10.1080/10543406.2019.1633660. Epub 2019 Jul 15.


The modifying effects of social support on psychological outcomes in patients with heart failure.

Blumenthal JA, Zhu Y, Koch GG, Smith PJ, Watkins LL, Hinderliter AL, Hoffman BM, Rogers JG, Chang PP, O'Connor C, Johnson KS, Sherwood A.

Health Psychol. 2019 Jun;38(6):502-508. doi: 10.1037/hea0000716. Epub 2019 Apr 18.


Statistical planning in confirmatory clinical trials with multiple treatment groups, multiple visits, and multiple endpoints.

Sun H, Snyder E, Koch GG.

J Biopharm Stat. 2018;28(1):189-211. doi: 10.1080/10543406.2017.1378664. Epub 2017 Nov 6.


Blood pressure reactivity to psychological stress is associated with clinical outcomes in patients with heart failure.

Sherwood A, Hill LK, Blumenthal JA, Adams KF Jr, Paine NJ, Koch GG, O'Connor CM, Johnson KS, Hinderliter AL.

Am Heart J. 2017 Sep;191:82-90. doi: 10.1016/j.ahj.2017.07.003. Epub 2017 Jul 12.


A model-based conditional power assessment for decision making in randomized controlled trial studies.

Zou B, Cai J, Koch GG, Zhou H, Zou F.

Stat Med. 2017 Dec 30;36(30):4765-4776. doi: 10.1002/sim.7454. Epub 2017 Sep 4.


Sensitivity analysis for missing dichotomous outcome data in multi-visit randomized clinical trial with randomization-based covariance adjustment.

Li S, Koch GG, Preisser JS, Lam D, Sanchez-Kam M.

J Biopharm Stat. 2017;27(3):387-398. doi: 10.1080/10543406.2017.1289955. Epub 2017 Feb 8.


Randomization-based adjustment of multiple treatment hazard ratios for covariates with missing data.

Lam D, Koch GG, Preisser JS, Saville BR, Hussey MA.

J Biopharm Stat. 2017;27(3):373-386. doi: 10.1080/10543406.2017.1289954. Epub 2017 Feb 8.


Statistical planning to address strongly correlated endpoints for inferential subgroups: An innovative approach for an illustrative clinical trial with complex multiplicity issues.

Sun H, Binkowitz B, Koch GG.

J Biopharm Stat. 2017;27(3):399-415. doi: 10.1080/10543406.2017.1289945. Epub 2017 Feb 10.


Effects of Coping Skills Training on Quality of Life, Disease Biomarkers, and Clinical Outcomes in Patients With Heart Failure: A Randomized Clinical Trial.

Sherwood A, Blumenthal JA, Koch GG, Hoffman BM, Watkins LL, Smith PJ, O'Connor CM, Adams KF Jr, Rogers JG, Sueta C, Chang PP, Johnson KS, Schwartz J, Hinderliter AL.

Circ Heart Fail. 2017 Jan;10(1). pii: e003410. doi: 10.1161/CIRCHEARTFAILURE.116.003410.


Commentary for the Missing Data Working Group's perspective for regulatory clinical trials, estimands, and sensitivity analyses.

Koch GG, Wiener LE.

Stat Med. 2016 Jul 30;35(17):2887-93. doi: 10.1002/sim.6954. No abstract available.


On variance estimate for covariate adjustment by propensity score analysis.

Zou B, Zou F, Shuster JJ, Tighe PJ, Koch GG, Zhou H.

Stat Med. 2016 Sep 10;35(20):3537-48. doi: 10.1002/sim.6943. Epub 2016 Mar 21.


Correlation of in Situ Oxazolidine Formation with Highly Synergistic Cytotoxicity and DNA Cross-Linking in Cancer Cells from Combinations of Doxorubicin and Formaldehyde.

Barthel BL, Mooz EL, Wiener LE, Koch GG, Koch TH.

J Med Chem. 2016 Mar 10;59(5):2205-21. doi: 10.1021/acs.jmedchem.5b01956. Epub 2016 Feb 26.


Oxidized LDL and Fructosamine Associated with Severity of Coronary Artery Atherosclerosis in Insulin Resistant Pigs Fed a High Fat/High NaCl Diet.

Nichols TC, Merricks EP, Bellinger DA, Raymer RA, Yu J, Lam D, Koch GG, Busby WH Jr, Clemmons DR.

PLoS One. 2015 Jul 6;10(7):e0132302. doi: 10.1371/journal.pone.0132302. eCollection 2015.


Nonparametric randomization-based covariate adjustment for stratified analysis of time-to-event or dichotomous outcomes.

Hussey MA, Koch GG, Preisser JS, Saville BR.

J Biopharm Stat. 2016;26(3):579-89. doi: 10.1080/10543406.2015.1052483. Epub 2015 Jun 23.


A new era in idiopathic pulmonary fibrosis: considerations for future clinical trials.

Collard HR, Bradford WZ, Cottin V, Flaherty KR, King TE Jr, Koch GG, Kolb M, Martinez FJ, Montgomery B, Raghu G, Richeldi L, Rose D, Wells AU, Brown KK.

Eur Respir J. 2015 Jul;46(1):243-9. doi: 10.1183/09031936.00200614. Epub 2015 Apr 21.


Analysis of repeated low-dose challenge studies.

Nolen TL, Hudgens MG, Senb PK, Koch GG.

Stat Med. 2015 May 30;34(12):1981-92. doi: 10.1002/sim.6462. Epub 2015 Mar 9.


On model selections for repeated measurement data in clinical studies.

Zou B, Jin B, Koch GG, Zhou H, Borst SE, Menon S, Shuster JJ.

Stat Med. 2015 May 10;34(10):1621-33. doi: 10.1002/sim.6414. Epub 2015 Jan 23.


Sensitivity analysis for missing outcomes in time-to-event data with covariate adjustment.

Zhao Y, Saville BR, Zhou H, Koch GG.

J Biopharm Stat. 2016;26(2):269-79. doi: 10.1080/10543406.2014.1000549. Epub 2015 Jan 30.


Genetic association analysis under complex survey sampling: the Hispanic Community Health Study/Study of Latinos.

Lin DY, Tao R, Kalsbeek WD, Zeng D, Gonzalez F 2nd, Fernández-Rhodes L, Graff M, Koch GG, North KE, Heiss G.

Am J Hum Genet. 2014 Dec 4;95(6):675-88. doi: 10.1016/j.ajhg.2014.11.005.


Statistical Perspectives on Subgroup Analysis: Testing for Heterogeneity and Evaluating Error Rate for the Complementary Subgroup.

Alosh M, Huque MF, Koch GG.

J Biopharm Stat. 2015;25(6):1161-78. doi: 10.1080/10543406.2014.971169. Epub 2014 Oct 20.


The Haemophilus ducreyi trimeric autotransporter adhesin DsrA protects against an experimental infection in the swine model of chancroid.

Fusco WG, Choudhary NR, Routh PA, Ventevogel MS, Smith VA, Koch GG, Almond GW, Orndorff PE, Sempowski GD, Leduc I.

Vaccine. 2014 Jun 24;32(30):3752-8. doi: 10.1016/j.vaccine.2014.05.031. Epub 2014 May 18.


A multiple imputation method for sensitivity analyses of time-to-event data with possibly informative censoring.

Zhao Y, Herring AH, Zhou H, Ali MW, Koch GG.

J Biopharm Stat. 2014;24(2):229-53. doi: 10.1080/10543406.2013.860769.


An overview of statistical planning to address subgroups in confirmatory clinical trials.

Koch GG, Schwartz TA.

J Biopharm Stat. 2014;24(1):72-93. doi: 10.1080/10543406.2013.856021. Review.


Neurobehavioral functioning and survival following lung transplantation.

Smith PJ, Blumenthal JA, Carney RM, Freedland KE, O'Hayer CVF, Trulock EP, Martinu T, Schwartz TA, Hoffman BM, Koch GG, Davis RD, Palmer SM.

Chest. 2014 Mar 1;145(3):604-611. doi: 10.1378/chest.12-2127.


Missing radiographic data handling in randomized clinical trials in rheumatoid arthritis.

Huang X, Jiao L, Wei L, Quan H, Teoh L, Koch GG.

J Biopharm Stat. 2013;23(6):1435-52. doi: 10.1080/10543406.2013.834913.


Echocardiographic assessment of cardiac valvular regurgitation with lorcaserin from analysis of 3 phase 3 clinical trials.

Weissman NJ, Sanchez M, Koch GG, Smith SR, Shanahan WR, Anderson CM.

Circ Cardiovasc Imaging. 2013 Jul;6(4):560-7. doi: 10.1161/CIRCIMAGING.112.000128. Epub 2013 May 9.


Association of anxiety and depression with all-cause mortality in individuals with coronary heart disease.

Watkins LL, Koch GG, Sherwood A, Blumenthal JA, Davidson JR, O'Connor C, Sketch MH.

J Am Heart Assoc. 2013 Mar 19;2(2):e000068. doi: 10.1161/JAHA.112.000068.


A multistage analysis strategy for a clinical trial to assess successively more stringent criteria for a primary endpoint with a low event rate.

Li S, Hussey MA, Schwartz TA, Koch GG.

Pharm Stat. 2013 Mar-Apr;12(2):65-73. doi: 10.1002/pst.1554. Epub 2013 Feb 19.


Evaluating treatment efficacy by multiple end points in phase II acute heart failure clinical trials: analyzing data using a global method.

Sun H, Davison BA, Cotter G, Pencina MJ, Koch GG.

Circ Heart Fail. 2012 Nov;5(6):742-9. doi: 10.1161/CIRCHEARTFAILURE.112.969154. Epub 2012 Oct 11.


Gravity changes during animal development affect IgM heavy-chain transcription and probably lymphopoiesis.

Huin-Schohn C, Guéguinou N, Schenten V, Bascove M, Koch GG, Baatout S, Tschirhart E, Frippiat JP.

FASEB J. 2013 Jan;27(1):333-41. doi: 10.1096/fj.12-217547. Epub 2012 Sep 19.


Flexible analytical methods for adding a treatment arm mid-study to an ongoing clinical trial.

Elm JJ, Palesch YY, Koch GG, Hinson V, Ravina B, Zhao W.

J Biopharm Stat. 2012;22(4):758-72. doi: 10.1080/10543406.2010.528103.


Dose-Weighted Adjusted Mantel-Haenszel Tests for Numeric Scaled Strata in a Randomized Trial.

Gansky SA, Cheng NF, Koch GG.

Stat Biopharm Res. 2011 May 1;3(2):266-275.


Permutation criteria to evaluate multiple clinical endpoints in a proof-of-concept study: lessons from Pre-RELAX-AHF.

Davison BA, Cotter G, Sun H, Chen L, Teerlink JR, Metra M, Felker GM, Voors AA, Ponikowski P, Filippatos G, Greenberg B, Teichman SL, Unemori E, Koch GG.

Clin Res Cardiol. 2011 Sep;100(9):745-53. doi: 10.1007/s00392-011-0304-5. Epub 2011 Mar 17.


Coping effectively with heart failure (COPE-HF): design and rationale of a telephone-based coping skills intervention.

Sherwood A, O'Connor CM, Routledge FS, Hinderliter AL, Watkins LL, Babyak MA, Koch GG, Adams KF Jr, Dupree CS, Chang PP, Hoffman BM, Johnson J, Bowers M, Johnson KS, Blumenthal JA.

J Card Fail. 2011 Mar;17(3):201-7. doi: 10.1016/j.cardfail.2010.11.001. Epub 2011 Jan 21.


Worsening depressive symptoms are associated with adverse clinical outcomes in patients with heart failure.

Sherwood A, Blumenthal JA, Hinderliter AL, Koch GG, Adams KF Jr, Dupree CS, Bensimhon DR, Johnson KS, Trivedi R, Bowers M, Christenson RH, O'Connor CM.

J Am Coll Cardiol. 2011 Jan 25;57(4):418-23. doi: 10.1016/j.jacc.2010.09.031.


Time to All-cause Treatment Discontinuation as the Primary Outcome in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Schizophrenia Study.

Davis SM, Stroup TS, Koch GG, Davis CE, Rosenheck RA, Lieberman JA.

Stat Biopharm Res. 2011;3(2):253-265. doi: 10.1198/sbr.2011.10013. Epub 2012 Jan 1.


The anti-ischemic mechanism of action of ranolazine in stable ischemic heart disease.

Stone PH, Chaitman BR, Stocke K, Sano J, DeVault A, Koch GG.

J Am Coll Cardiol. 2010 Sep 14;56(12):934-42. doi: 10.1016/j.jacc.2010.04.042.


One in four people may develop symptomatic hip osteoarthritis in his or her lifetime.

Murphy LB, Helmick CG, Schwartz TA, Renner JB, Tudor G, Koch GG, Dragomir AD, Kalsbeek WD, Luta G, Jordan JM.

Osteoarthritis Cartilage. 2010 Nov;18(11):1372-9. doi: 10.1016/j.joca.2010.08.005. Epub 2010 Aug 14.


Multivariate Mann-Whitney estimators for the comparison of two treatments in a three-period crossover study with randomly missing data.

Kawaguchi A, Koch GG.

J Biopharm Stat. 2010 Jul;20(4):720-44. doi: 10.1080/10543401003618108.


Sample size calculations for crossover thorough QT studies: satisfaction of regulatory threshold and assay sensitivity.

Anand SP, Murray SC, Koch GG.

J Biopharm Stat. 2010 May;20(3):587-603. doi: 10.1080/10543400903582000.


Graphical displays for clarifying how allocation ratio affects total sample size for the two sample logrank test.

Saville BR, Kim YS, Koch GG.

Pharm Stat. 2011 Jan-Feb;10(1):40-4. doi: 10.1002/pst.407.


Effects of tissue factor, thrombomodulin and elevated clotting factor levels on thrombin generation in the calibrated automated thrombogram.

Machlus KR, Colby EA, Wu JR, Koch GG, Key NS, Wolberg AS.

Thromb Haemost. 2009 Nov;102(5):936-44. doi: 10.1160/TH09-03-0180.


Heparin cofactor II in atherosclerotic lesions from the Pathobiological Determinants of Atherosclerosis in Youth (PDAY) study.

Rau JC, Deans C, Hoffman MR, Thomas DB, Malcom GT, Zieske AW, Strong JP, Koch GG, Church FC.

Exp Mol Pathol. 2009 Dec;87(3):178-83. doi: 10.1016/j.yexmp.2009.09.003. Epub 2009 Sep 9.


Preclinical efficacy of a carboxylesterase 2-activated prodrug of doxazolidine.

Barthel BL, Zhang Z, Rudnicki DL, Coldren CD, Polinkovsky M, Sun H, Koch GG, Chan DC, Koch TH.

J Med Chem. 2009 Dec 10;52(23):7678-88. doi: 10.1021/jm900694z.


Applications of extensions of bivariate rank sum statistics to the crossover design to compare two treatments through four sequence groups.

Kawaguchi A, Koch GG, Ramaswamy R.

Biometrics. 2009 Sep;65(3):979-88. doi: 10.1111/j.1541-0420.2008.01170.x. Epub 2009 Jan 23.


Electrocardiographic determination of culprit lesion site in patients with acute coronary events.

Wang SS, Paynter L, Kelly RV, Koch GG, Skains MS, Gettes LS.

J Electrocardiol. 2009 Jan-Feb;42(1):46-51. doi: 10.1016/j.jelectrocard.2008.08.043. Epub 2008 Oct 30.


Factors associated with failed retrieval of the Günther Tulip inferior vena cava filter.

Marquess JS, Burke CT, Beecham AH, Dixon RG, Stavas JM, Sag AA, Koch GG, Mauro MA.

J Vasc Interv Radiol. 2008 Sep;19(9):1321-7. doi: 10.1016/j.jvir.2008.06.004. Epub 2008 Jul 21.


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