Publications

Related Books and Book Chapters

  • Committee on Clinical Trial Guidelines (2006).   Guidelines for Pre-clinic and Clinical Trial Evaluations for Chinese Herb Medicine Treatment of Osteoporosis and Osteoporotic Fractures. Beijing, People’s Health Publications, 2006.
  • J. Bartroff, T.L. Lai and M.C. Shih (2013).  Sequential Experimentation in Clinical Trials: Design and  Analysis. Springer, New York.
  • Y. Lu, J. Fang, L. Tian, H. Jin, eds. (2015).  Advanced Medical Statistics World Scientific.
  • J. Chen, J. Heyse and T.L. Lai (2017).  Medical Product Safety Evaluation: Biological Models and Statistical Methods. Forthcoming from Chapman & Hall.
  •  A.S. Deng, T.L. Lai and K.W. Tsang (2017). Data Science and Decision Analytics Forthcoming from Wiley.
  • Lai T, Lu Y, Tsang KW. Adaptive Designs. Oncology Clinical Trials, 2nd Ed. Kelly WK. and Halabi S. (eds). New York, Springer, 2017 (in press).
  • T.L. Lai, P.W. Lavori and K.W. Tsang (2018). Innovative Study Design and Statistical Analysis in Evidence-Based Medicine. Forthcoming from Chapman & Hall.

Related Papers

(2001)  Lai TL.  Celebrating the New Millennium: Editors’ Invited Article I.  Sequential analysis: Some classical problems and new challenges (with discussion and rejoinder). Statistica Sinica; 11(2):303–351.

(2001) Bloch, DA, Lai TL, Tubert-Bitter P.  One-sided tests in clinical trials with multiple endpoints. Biometrics; 57(4):1039–1047.

(2003)  Lai TL, Shih MC, Zhu G.  Statistics in pharmacology and pre-clinical studies. Advanced Medical Statistics; 409–442.

(2003) Lai TL, Shih MC.  Nonparametric estimation in nonlinear mixed effects models. Biometrika; 90(1):1–13.

(2003) Lai TL, Shih MC.  A hybrid estimator in nonlinear and generalized linear mixed effects models. Biometrika; 90(4):859–879.

(2003) Lu Y, Jin H, Genant HK. On the equivalence of two diagnostic tests based on paired observations. Statistics in Medicine 2003 Oct; 22(10):3029-44.

(2004)  Lai TL, Shih MC.  Power, sample size and adaptation considerations in the design of group sequential trials. Biometrika; 91(3):509–528.

(2005) Lu Y, Jin H, Lamborn KR.  A design of phase II cancer trials with both total and complete response endpoints. Statistics in Medicine 2005 Oct 30; 24(20):3155-70.

 (2006)  Lai TL, Shih MC, Zhu G.  Modified Haybittle-Peto group sequential designs for testing superiority and non-inferiority hypotheses in clinical trials. Stat. Med.;  25(7):1149-67.  PMID: 16189814 .  

(2006)  Lai Tl, Shih MC, Wong SP.  A new approach to modeling covariate effects and individualization in population pharmacokinetics-pharmacodynamics. J. Pharmacok. Pharmacodynam. 33(1):49–74.  PMID: 16402288  doi: 10.1007/s10928-005-9000-2

(2006)  Lai TL, Li Wenzhi.  Confidence intervals in group sequential trials with random group sizes and applications to survival analysis. Biometrika 93(3):641–654. doi: 10.1093/biomet/93.3.641

(2007)  Bloch DA, Lai TL, Su Z, Tubert-Bitter P.  A combined superiority and non-inferiority approach to multiple endpoints in clinical trials. Stat. Med.  26(6):1193–1207.  PMID: 16791905  doi: 10.1002/sim.2611

(2008)  Bartroff J, Lai TL.  Efficient adaptive designs with mid-course sample size adjustment in clinical trials. Stat. Med. 27(10):1593–1611.  doi: 10.1002/sim.3201

(2009)  Jin H, Lu Y.  A non-inferiority test of areas under two parametric ROC curves.  Contemp Clin Trials. 2009 Jul; 30(4):375-379. PMID: 19336261  doi:10.1016/j.cct.2009.03.003

(2009)  Fan S, Venook AP, Lu Y.  Design issues in dose-finding phase I trials for combinations of two agents. Journal of Biopharmaceutical Statistics 2009; 19(3): 509-23.  PMID: 19384692.

(2009)  Wisniewski, SR, Rush, AJ, Nierenberg, AA, Gaynes, BN, Warden, D, Luther, JF, McGrath, PJ, Lavori, PW, Thase, ME, Fava, M, Trivedi, MH.  Can phase III trial results of antidepressant medications be generalized to clinical practice? A STAR*D report.  Am. J. Psychiatry; 166(5):599-607.  PMID: 19339358.

(2010)  Shih MC, Lai TL, Heyse JF, Chen J.  Sequential generalized likelihood ratio tests for vaccine safety evaluation. Stat. Med. 29(26):2698–2708. PMID: 20799244  PMCID: PMC2975406   doi: 10.1002/sim.4036

(2011)   Bartroff J, Lai TL.  Incorporating individual and collective ethics into Phase I cancer trial designs.  Biometrics 67(2):596–603. PMID: 20731643  PMCID: PMC4485382   doi: 10.1111/j.1541-0420.2010.01471.x

(2011) Lai TL, Lavori PW.  Innovative clinical trial designs: Toward a 21st-century health care system. Stat. Biosci. 3(2):145–168.  PMID: 26140056, PMCID:PMC4485389.  doi: 10.1007/s12561-011-9042-5.

(2012)  Lai TL, Lavori PW, Shih MC.  Adaptive Trial Designs.  Annual Review of Pharmacology and Toxicology, Vol. 52, pp 101-110.

(2012) Lai TL, Lavori PW, Shih MC.  Sequential design of Phase II-III cancer trials. Stat. Med. 31(18):1944–1960.  PMID: 22422502, PMCID:PMC4532356.  doi: 10.1002/sim.5346.

(2012)  Lai TL, Lavori PW, Shih MC, Sikic BI.  Clinical trial designs for testing biomarker-based personalized therapies. Clin. Trials. 9(2): 141–154. doi: 10.1177/1740774512437252.  PMID: 22397801, PMCID: PMC4296980.

(2012) Fan S, Lu Y, Wang Y.  A Simple Bayesian Decision-Theoretic Design for Dose-Finding Trials.  Statistics in Medicine 2012 31(28):3719-3730.  PMID: 22763943  doi: 10.1002/sim.5438.

 (2012) Lu Y, Fan S. On the Time to Conclusion of Phase II Cancer Clinical Trials and Its Application in Trial Designs.  Statistics in Biopharmaceutical Research. 2012; 4(4):324-335.

 (2013)  Lai TL, Liao OY, Kim DW.   Group sequential designs for developing and testing biomarker-guided personalized therapies in comparative effectiveness research.  Contemp. Clin. Trials;  36(2):651–663.   PMID: 23994669  doi: 10.1016/j.cct.2013.08.007

(2014)  Bartroff J, Lai TL, Narasimhan B.  A new approach to designing phase I-II cancer trials for cytotoxic chemotherapies. Stat. Med. 33, 2718–2735.  PMID: 24577750  PMCID:PMC4048734.  doi: 10.1002/sim.6124

(2014)  TL Lai, PW Lavori, O Yueh-Wen Liao.  Adaptive choice of patient subgroup for comparing two treatments. Contemporary Clinical Trials, Vol. 39(2), 191–200.   PMID: 25205644  PMCID: PMC4470707  doi: 10.1016/j.cct.2014.09.001

(2015) Schnurr PP, Chard KM, Ruzek JI, Chow BK, Shih M-C, Resick PA, Foa EB, Marx BP, Huang G. and Lu Y.  Design of VA Cooperative Study #591: CERV-PTSD, Comparative Effectiveness Research in Veterans with PTSD. Contemporary Clinical Trials Volume 41, March 2015, Pages 75-84. doi:10.1016/j.cct.2014.11.017

 (2015)  He P, Lai TL, Su Z.  Design of clinical trials with failure-time endpoints and interim analyses: An update after fifteen years. Contemp. Clin. Trials 10th Anniversary Special Issue, 45 (Part A):103–112.   PMID: 26031459  doi: 10.1016/j.cct.2015.05.018

(2015)  Lai TL, Lavori PW, Tsang KW.   Adaptive design of confirmatory trials: Advances and challenges. Contemp. Clin. Trials 10th Anniver- sary Special Issue, 45 (Part A):93–102.   PMID: 26079372  PMCID: PMC4639447   doi: 10.1016/j.cct.2015.06.007

(2015)  Shih MC, Turakhia M, Lai TL.   Innovative designs of point-of-care comparative effectiveness trials. Contemp. Clin. Trials 10th An- niversary Special Issue, 45 (Part A):61–68.   PMID: 26099528  PMCID: PMC4639459  doi: 10.1016/j.cct.2015.06.014

 (2016)  M.G. Lansberg, N.S. Bhat, S.D. Yeatts, Y.Y. Palesch, J.P. Broderick, G.W. Albers, T.L. Lai and P.W. Lavori.  Power of an adaptive trial design for endovascular stroke studies: Simulations using IMS (Interventional Management of Stroke) III data. Stroke, 47(12):2931-2937.  PMID: 27895297, PMCID: PMC5134921.

 (2016)  Belitskaya I, Wang H, Shih MC, Tian L, Doros G, Lew RA, and Lu Y.  A New Overall-Subgroup Simultaneous Test for Optimal Inference in Biomarker-Targeted Confirmatory Trials.  Statistics in Biosciences, DOI: 10.1007/s12561-016-9174-8.

(2017)  Lee BL, Fan S, Lu Y.  A curve-free Bayesian decision-theoretic design for two-agent phase I trials.  Journal of Biopharmaceutical Statistics, 27(1):34-43. PMID: 26882373.

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