date: may 2000 - rutgers university · 2019-06-24 · invited workshop session chair and organizer...

WJ SHIH CV of 26

CURRICULUM VITAE

DATE: January 20, 2015

NAME: Weichung Joe Shih, Ph.D.

PRESENT TITLE:

Professor and Chairman, Department of Biostatistics, School of Public Health (SPH)

Director of Biometrics Division, The Cancer Institute of New Jersey (CINJ) Rutgers,

The State University of New Jersey

OFFICE ADDRESS: Department of Biostatistics

Rutgers School of Public Health

Rutgers, The State University of New Jersey

683 Hoes Lane West, Room 216; PO Box 9

Piscataway, NJ 08854

PHONE: (H) 732-885-6827 (O) 732-235-6791 / E-mail: [email protected]

CITIZENSHIP: USA

GRADUATE EDUCATION:

University of Rhode Island, Kingston, R.I. 1976 M.A. Mathematics

University of Minnesota, Minneapolis/St. Paul 1981 PH.D. Statistics

ACADEMIC APPOINTMENTS:

Fall 1999- Present Professor (tenured) and Chairman*, Department of

Biostatistics, Rutgers School of Public Health (Primary

appointment)

Director of Biometrics Division*, Rutgers Cancer Institute

of New Jersey (Joint appointment)

Professor of Biostatistics, Department of Environmental

and Community Medicine, Robert Wood Johnson Medical

School (Secondary appointment)

Rutgers, The State University of New Jersey

Faculty of Graduate School of Rutgers University

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Full Member of the Rutgers Cancer Institute of New Jersey

(Clinical Investigation Group)

(*Founding Chair and Founding Director)

(*Founding Director of the Biostatistics Core of NIEHS Center of Excellence, 2002)

July 2005 Visiting Scholar, Department of Probability and Statistics,

School of Mathematical Sciences, Peking University,

Beijing, China.

1997- 1998 Visiting Professor I (Adjunct position)

Department of Statistics and Institute of Biostatistics,

Rutgers University, State University of New Jersey

1993-1994 Visiting Scholar

Department of Statistics,


Fall/1988 Visiting Lecturer

Graduate School of Management,


1981 -1982 Assistant Professor (Tenure track)

Department of Mathematics and Statistics

Tulane University, New Orleans, LA.

INDUSTRY APPOINTMENTS:

Position Institution Year

Senior Investigator & Biostatistics, Research Information Management 1993-

Director, Scientific Staff & Epidemiology, Merck Research Laboratories. 1999

Senior Research Fellow & Biostatistics, Research Data Systems 1989-

Associate Director & Epidemiology, Merck Research Laboratories. 1992

Senior Biometrician Biostatistics and Research Data Systems 1986-

Merck Research Laboratories. 1988

Biometrician Biostatistics and Research Data Systems 1982-

Merck Research Laboratories. 1985

MANAGEMENT RESPONSIBILITIES

At Rutgers University:

2001-Present Chairman, Department of Biostatistics, School of Public Health;

Director, Biometrics Division, The Cancer Institute of New Jersey

2002 - 20010 Director, Biostatistics Core, NIEHS Center of Excellence

Fall 1999 – 2001 (Legacy UMDNJ)

Founding Director: Planning, developing, and directing a new Biometrics

Division in the newly formed School of Public Health and in the Cancer

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Institute of New Jersey, Robert Wood Johnson Medical School. Also in

charge of the Center of Biostatistics, a consulting unit of Biostatistics in

UMDNJ.

At Merck:

1997- 99 Biostatistician of Fosamax team.

1995- 99 Chair of the Technical Issues Committee. Responsible for tracking research

activities on statistical issues, and provided mentor support to Merck statisticians’

research efforts.

1994- 96 Chair of Schor Visiting Scholar Committee. Recruited and hosted four

Associate Professors as Visiting Scholars at Merck Research Laboratories.

1992- 99 Chair of Editorial Board of Biostatistics Technical Report Series.

1987- 89 Responsible for coordinating three international teams, led one Associate

Director, two Ph.D. project statisticians in the US and UK for a major New Drug

Application effort (Diabetic complications).

PROFESSIONAL ORGANIZATIONS AND THEIR COMMITTEES:

- American Statistical Association (ASA)

ASA Presidential Nomination Committee (2007-2009).

Appointed by the ASA President to the Committee on Scientific Freedom and Human

Rights for the American Statistical Association (2000-2002).

Treasurer for ASA New Jersey Chapter (1998 - 2000).

Chair and Organizer of Invited Paper Session for Joint Statistical Meetings (1999, 2001).

Chair of Program Committee for ASA New Jersey Chapter (1993 - 94).

Symposium Committee for ASA New Jersey Chapter (1994 - 95, 1998 - 01).

Continue Education Committee, ASA New Jersey Chapter (1996 - 97).

- The International Biometric Society (IBS)

Invited Paper Session Chair and Organizer for Biometric Society ENAR Meetings (1994). - International Chinese Statistical Association (ICSA)

Chair of Membership Committee, ICSA (1998 - 99).

Chair of the Biometrics Section (2000-2001).

Applied Statistics Symposium Program Committee (1994, 2000).

Biometrics Section Founding Committee for ICSA (1993).

- Society for Chinese Bioscientists in America (SCBA)- Division of Bio/Pharmaceutical Sciences

Adviser to the SCBA publication, membership and directory committee (1996).

- International Society for Clinical Biostatistics (ISCB)

- Society for Clinical Trials (SCT)

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Candidate for Board of Directors (1999-2001).

Annual Meeting Program Committee (1999).

Invited Workshop Session Chair and organizer for SCT & ISCB Joint Meetings (1997).

HONORS AND AWARDS:

Fellow of the American Statistical Association (1996).

Excellence in Teaching Award, The Student Government Association, UMDNJ-School of

Public Health (2002).

Excellence in Service Award for Participating in the Food & Drug Administration

Advisory Board – United States Department of Human Health Services (2006)

Elected Member, International Statistical Institute (ISI) (2009)

Excellence in Research Award, The UMDNJ Foundation (2011)

Outstanding Contribution and Support Award from Sino-American Pharmaceutical

Professional Association (2014)

EDITORIAL BOARD

Associate Editor: Statistics in Medicine (2000 – present).

Associate Editor: Clinical Cancer Research (2001 - 2012)

Associated Editor: Journal of Controlled Clinical Trials (1994 - 2003).

Associated Editor: Statistics in Biopharmaceutical Research (2007-2010).

Associated Editor: Clinical Trials (2003-2010).

Associated Editor: Statistica Sinica (1996 - 2008).

Associate Editor: Journal of Biopharmaceutical Statistics (2000 – 2002).

Associated Editor: ICSA Bulletin (1996 – 1999).

Statistical Reviewer for Journal of Periodontology (1997 - 1998).

MANUSCRIPT REFEREE FOR:

Journal of American Statistical Association

Journal of Statistical Computation and Simulation

Journal of Computational Statistics and Data Analysis

Journal of Controlled Clinical Trials

American Statisticians

Communications in Statistics - A

Journal of Periodontology

Statistics in Medicine

Biometrics

Statistica Sinica

Clinical Cancer Research

Journal of Biopharmaceutical Statistics

SERVICE ON NATIONAL AND INTERNATIONAL COMMITTEES:

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American Heart Association Community Voluntary Program Coordinator (1992).

FDA Center for Drug Evaluation and Research Consult and Expert (2001).

NIH - NINDS Scientific review committee for the Statistical Coordinating Center

of the Parkinson's Disease Neuroprotection Clinical Trial (2001).

FDA arthritis Advisory Committee (2001-2002).

FDA Gastrointestinal Advisory Committee (2003 – 2006)

AACR–FDA–NCI Cancer Biomarkers Collaborative Bioinformatics

Subcommittee (2007)

National Institute of Mental Health (NIMH) Grant review committee (2006-2007)

NIEHS Review panel for P42 Superfund Basic Research Program (2007, 2008)

American Association for Cancer Research (AACR)-FDA-NCI Cancer

Biomarkers Collaborative Bioinformatics Subcommittee, 2007.

American Association for Cancer Research (AACR) 2008 Annual Meeting

Program Committee member (review and select abstracts), 2008

American Association for Cancer Research (AACR) 2008 Annual Meeting

Educational Program member

Biopharmaceutical Chapter of American Statistical Association Fellow

Nomination Committee (2006-07)

American Statistical Association Presidential Nomination Committee (2007-

2010)

National Academy of Science’s appointment as a member of the National

Research Council’s Panel on Handling Missing Data in Clinical Trials. (2009-

2011).

National Science Council, Taiwan, R.O.C. (1997, 2000).

Advisory Committee of National Health Research Institutes, Taiwan, ROC

(1997).

SERVICE ON LOCAL COMMUNITY COMMITTEES:

New Jersey Piscataway Township Mayor's Advisor on Culture & Arts

Commission (1993).

New Jersey Public Schools Education Strategic Planning Board (1993-94).

Judge of N.J. Regional Science Fair for ASA New Jersey Chapter (1995).

Piscataway Township Schools Counseling Advisory Council (1996-97).

Grant Reviewer for State of New Jersey Commission on Cancer Research (2000).

External advisory board for Nevada Cancer Institute (2006-2011) – DSMB

activities.

External advisory board for MPD-RC (NCI funded), Mount Sinai School of

Medicine (2009-2013).

RUTGERS (Legacy UMDNJ) COMMITTEES

• School of Public Health:

Executive Committee Piscataway/New Brunswick Campus (1999-present)

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Chair of Appointment & Promotion Committee (2001-2012)

Curriculum Committee Piscataway/New Brunswick Campus (1999-2006)

Doctoral Program Committee Piscataway/New Brunswick Campus (1999-

present)

SPH Dean's Search Committee (2001)

• Rutgers Cancer Institute of New Jersey (1999-present):

Scientific Council;

Scientific Review Board;

Executive Council

Rutgers (legacy UMDNJ) Scientific Research Integrity Committee (2008-2011)

• (legacy) UMDNJ, NJIT, and PHRI Initiative Committee on Bioinformatics

(2000-2001)

• (legacy) UMDNJ Informatics Institute Steering Committee (2001)

• (legacy) UMDNJ Black Infant Mortality Research Committee (1999-2000)

TEACHING RESPONSIBILITIES:

Courses taught at Tulane University, Rutgers University (Legacy UMDNJ) School of Public

Health, and Professional Workshops:

Biostatistics II;

Experimental Designs;

Linear Models and Regression Analysis;

Statistics Theory I & II;

Applied Statistical Methods;

Advanced topics: Group Sequential and Adaptive Designs

Clinical Trials – Design and Analysis of Medical Experiments;

Short course in consulting and making effective statistical presentations.

SPONSORSHIP (Primary Mentorship) OF CANDIDATES FOR POSTGRADUATE

DEGREE:

Weili He (2002): Joint models to assess treatment effects on disease markers and clinical

events

Pei-Ling Chu (2005): Model based designs for phase I cancer clinical trials

Gaohong Dong (2010): A study of stagewise phase II and phase II/III designs for clinical

trials

Shiansong Li (2014): Bayesian statistical analysis in a phse II dose-finding trial with

survival endpoint in patients with B-cell chronic lymphocytic leukemia

Lixian Peng (2015): Design of Primary and Sensitivity Analyses for Handling Non-Future

Dependence Missing Data in Clinical Trials with an Emphasis on the Type-I Error Rate

Using Multiple Imputation and Pattern Mixture Model Approach

Xinquen Chen (2015): A Model to Select Chemotherapy, Endocrine Therapy or Biologic

Agent to Advance to Phase III Trials for Advanced Breast Cancer

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RESEARCH GRANTS:

Active:

1. P30CA-72720-12 (R. DiPaola, PI) 4/6/12 – 2/28/17

NIH/NCI (Total amount: $16,186,115)

Cancer Center Support Grant

Role: Director of the Biostatistics Core (25% effort)

2. RO1 AT007036-01A1 (Nanjoo Suh, PI) 8/1/12-7/31/17

NIH

Prevention of estrogen-mediated mammary carcinogenesis by mixtures of tocopherols

Role; Sub-award (No: 4770) – Lead Statistician

3. 1UM1CA186716-01 (R. DiPaola, PI) 3/19/14-2/28/19

NIH/NCI

Project Title: Wisconsin and New Jersey Alliance in Precision Experimental Therapeutics

Role: Lead Statistician

4.1RO3 HD077422-01A1 (Thomas Hegyi, PI) 5/1/2014-4/30/2016

NICHD

Project Title: Unbound Fatty Acids and Unbound Bilirubin in Preterm Infants: The

Role of Intralipid

The goal of this project is to examine unbound fatty acid and unbound bilirubin levels

in preterm infants below 2000g birth weight treated with Intralipid. Role: Project statistician

Completed:

1. CA-72720-10 (W. Hait, PI) 3/1/00 – 2/28/05


Cancer Center Support Grant

Role: Director of the Biostatistics Core (25%)

2. P30 ES05022 (Gallo, Michael, PI) 4/01/02 - 4/01/07

NIEHS (Total amount: $6,999,342)

NIEHS Center for Health Sciences


3. ES005022 (Z. Helmut, PI) 4/1/09-4/1/13

NIH/NIEHS (Total amount: $5,500,000)

Research Center in Environmental Health Sciences

Role: Director of the Biostatistics Core (0.5% effort)

4. R01CA114442 (A. Conney. PI) 7/1/06-5/31/13


Effect of Caffeine on UVB-induced Skin Cancer

Role: Project statistician (5% effort)

5. RO1CA130857 (A. Conney. PI) 7/1/12-4/30/14


Inhibition of skin cancer by caffeine: Effects on late stages of carcinogenesis

Role: Project statistician (5% effort)

6. W81XWH-09-1-0145 (DiPaola, R. PI) 4/30/09-3/31/14

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US Army (Total amount: $1,560,000)

CINJ Clinical Consortium for Prostate Cancer Research

Role: Project statistician (5%)

7. R21 CA144019-01A1 (J. Mehnert, PI) 7/07/10-6/30/13

NIH/NCI

A Phase 0 Trial of Hydroxychloroquine in Patients with Stage III and IV Resectable Menaloma

Role: Project statistician

8. RCA124975A (J. Gydos, PI) 7/10/07-5/31/12


Validation of Grm1 as a Therapeutic Target in Melanoma

Role: Project statistician (2.5%)

9. P01 CA-88961 (C.S. Yang, PI) 9/17/01 – 8/31/03

NIH/NCI

Program Project: Inhibition of Carcinogenesis by Tea and Tea Constituents


10. P20 CA-093980 (C.S. Yang, PI) 6/7/01 – 1/31/02

NIH/NCI

Planning grant: Mechanism of Cancer Chemoprevention by Dietary Constituents


11. PC011010 (R. DiPaola, PI) 1/1/02 – 12/31/04

US Department of Army

“A Phase I/II Trial of 13-Cis Retinoic Acid, Alpha Interferon, Taxotere, and

Estramustine (R.I.T.E.) for the Treatment of Hormone Refractory Prostate Cancer”


12. X982118-01 (W. J. Shih, PI) 10/1/01 – 9/30/02

New Jersey State DEP

“Data Analysis of Data From the NJ Air Deposition Network” (2.5%)

13. R1CA99951B (Eric Rubin, PI) 8/01/03-7/31/08

NIH/NCI

“Functional Studies of the Top 1-Binding Protein Topors”


14. CA094583-01A1 (Eric Rubin, PI) 6/1/02 – 5/31/04

NIH/NCI

“Toposisomerase Targeting and Resistence in Leukemia”


15. P01-ES11256-01 (George Lambert, PI) 9/30/01-9/29/06

NIEHS

R82939101-0 (George Lambert, PI) 11/01/01-10/31/06

EPA

Role: Project statistician

16. N01-CN-15011-72 (C.S. Yang, PI) 1/01/03-12/31/04

NCI/NIH

Role: Subcontract P.I. Biostatistics and Bioinformatics support to the “preclinical

evaluation of intermediate endpoints and their modulation by chemopreventive

agents.” (5%)

17. UMDNJ Foundation Grant (W. J. Shih, PI) 7/1/02-6/30/03

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To develop biostatistical methods for pilot, phase I and early phase II medical studies

and biological or environmental experiments (5%)

18. NCI-049902 (D. Toppmeyer, P.I.) 1/31/05-1/31/06

“Phase II Doxorubicin in WTp53 Breast Cancer”


19. DOD (R. Dipaola, PI) 10/23/05 – 102/23/06

“The Effect of Glycolytic Modulation in Prostate Cancer”


20. W81XWH-07-1-0403 (K. Hirshfield, PI) 5/7/07-5/6/10

US Army (Total amount: $466,500)

“The Impact of a Common MDM2 SNP on the Sensitivity of Breast Cancer to

Treatment”


21. UCA132194A (R. DiPaola, PI) 5/1/08-2/28/13


Early Clinical Trials of New Anti-Cancer Agents with Phase I Emphasis


CLINICAL TRIALS STATISTICAL COLLABORATIONS

1. Data Safety Monitoring Committees, Phase I, II and III clinical trials in CNS,

Diabetes, GI, Cardio-Vascular, Infectious Diseases, COPD, Ophthalmology,

Oncology. FDA AC Mockup meetings. (Sponsors include: J&J, Taisho, Progenics,

Myraid, Lux, Sanofi-Aventis, Daiichi-Sankyo, Merck-Schering-Plough, Novartis,

Allegan, Eisai, Celgene, Forest, Bayer (2004-present).

2. Merck Scientific Advisory Committee for osteoporosis and bone metastasis

prevention projects development. 2006-2011.

3. External advisory board for MPD-RC (NCI funded), Mount Sinai School of

Medicine (2009-present).

4. External advisory board for Nevada Cancer Institute (2006-2008) – DSMB activity

5. Aventis Protocol Review Committee (2002-2004).

6. Data Safety Monitoring Committee of ‘A Phase II, double-blind, placebo controlled

trial of gemcitabine plus placebo versus gemcitabine plus R115777 in patients with

advanced pancreatic cancer’ (1999-2001).

7. Data Safety Monitoring Committee of ‘A multicenter, randomized, double-blind,

placebo-controlled parallel study of oral alendronate sodium in pediatric patients

with severe osteogenesis imperfecta, followed by an open-label extension’ (2001-

2002).

8. JAMA independent reviewer for Forest Lab Memantine study MEM-MD-002

manuscript, “Use of Memantine in patients with moderate to severe Alzheimer’s

disease in combination with ongoing Acetylcholinesterase inhibitor treatment: A

randomized controlled trial” (2003).

9. Statistical advisor to clinical program development programs of ENZON

Pharmaceutical Inc. (2003-2005).

10. Statistical advisor to clinical program development programs of Sankyo

Pharmaceutical Inc. (2004-2008).

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11. Statistical advisor to clinical program development programs of Genta

Pharmaceutical Inc. (2004-2008)

12. Alendronate (Fosamax/Onclast) Phase IV &V projects (14 study protocols, 1997-99).

13. Alendronate (Fosamax) Biochemical Markers Research for Treatment & Prevention of

Osteoporosis (1997-99).

14. Alendronate (Fosamax)Treatment in Periodontal disease (1998-99).

15. Simvastatin Coronary Vascular Reactivity Trial. -- Data Safety Monitoring Board (95-

96).

16. Finasteride (Proscar) Prostate Cancer Program (ongoing collaboration with NIH.)

17. Alendronate (Fosamax) Fracture Intervention Trial -- Merck Liaison to the Data

Safety Monitoring Board (92-93).

18. Alendronate (Fosamax) Bone Mineral Density Studies Core Group (92-93).

19. Finasteride (Proscar) International Phase III Study in The Treatment of Benign

Prostatic Hyperplasia (90-92).

20. Lovastatin (Mevacor) Studies in Treating Hypercholesterolemia (89-90).

21. Lovastatin (Mevacor) Coronary Atherosclerosis Intervention Trial.

22. Scandinavian Simvastatin (Zocor) Survival Study (4S).

23. Ponalrestat Diabetic Complications Trial (6 protocols).

24. Lisinopril Hypertension and Congestive Heart Failure Trial (2 protocols).

25. Ivermectin Onchocerciasis Studies (3 protocols).

26. Imipenem Therapy for Serious Infections (6 protocols).

27. Norfloxacin For Treatment of Urinary Infection (2 protocols).

28. Sulindac in Treatment of Upper Respiratory Tract Infection (3 protocols).

PUBLICATIONS:

(A) Refereed Original Article in Journal

1. Shih, W.J. "NIM - A Binary Game" Applied Mathematics (Chinese), March 1972.

2. Shih, W.J. "Theorems on Equiperimeter" Applied Mathematics (Chinese), March

1973.

3. Shih, W. J. "Maximum Likelihood Estimation and Likelihood Ratio Test With

Incomplete Pairs" Journal of Statistical Computation and Simulation, Vol. 21,

1985.

4. Sabbaj, J.; Hoagland, V. L.; Shih, W. J. "Multiclinic Comparative Study of

Norfloxacin and Trimethoprim - Sulfamethoxazole for Treatment of Urinary Tract

Infection" Antimicrobial Agents and Chemotherapy, March, 1985.

5. Ebel, D. L.; Shih, W. J.; Rhymer, A. R. "A Multi-centre, Double-Blind

Randomized Study to Assess the Efficacy and Tolerance of Sulindac Versus

Placebo in Symptomatic Treatment of Patients With Upper Respiratory Tract

Infection" Current Medical Research and Opinion, Vol. 9, No. 10, 1985.

6. Shih, W. J.; Weisberg, S. "Detecting Influential Observations in Multiple Linear

Regression With Incomplete Data" Technometrics, Vol. 28, No. 3, August 1986.

7. Shih, W. J. "Maximum Likelihood Estimation and Likelihood Ratio Test for

Square Tables with Missing Data" Statistics in Medicine, Vol 6, 1987.

WJ SHIH CV of 26

8. Shih, W.J.; Binkowitz, B. "Median Versus Geometric Mean For Lognormal

Samples" Journal of Statistical Computations and Simulation, Vol 28, 1987.

9. Nalin, D.R.; Hart, C.B.; Shih, W.J.; Aziz, M.A. "Imipenem/Cilastin for Pediatric

Infections in Hospitalized Patients" Scan J. Infect. Dis, Suppl. 52, 1987.

10. Shih, W.J. "Testing for Case-Control studies with ordinal exposure variables"

Biometrics, Vol. 44, 1988.

11. Shih, W.J. "Nonparametric Simultaneous Prediction Intervals for Quality Control"

The Statistician Vol. 37, 1988.

12. Shih, W.J., Gould, A.L., and Hwang, I.K. "The Analysis of Titration Studies in

Phase III Clinical Trials" Statistics in Medicine, Vol. 8, 1989.

13. Shih, W.J. "Influence of Incomplete Observations in Multiple Linear Regression"

14. Journal of Statistics and Probability Letter, Vol. 8, 1989.

15. Shih, W.J. "Prediction Approaches to Sequentially Searching for an Optimal Dose".

Biometrics, Vol. 45, 1989.

16. Hwang, I.K., Shih, W.J., DeCani, J.S. "Group Sequential Designs Using a Family

of

17. Type I Error Spending Rate Functions" Statistics in Medicine, Vol. 9, 1990.

18. Chuang-Stein, C. and Shih, W. J. "A Note on the Analysis of Titration Studies"

Statistics in Medicine, Vol. 10, 1991.

19. Shih, W.J. and Wang, C. "Overview of Some Important Issues in Designing

Clinical Trials for Prevention of Chronic Diseases" Pharmaceutical Medicine, Vol.

5, 1991.

20. Gould, A. L. and Shih, W. J. "Sample Size Reestimation Without Unblinding for

Normally Distributed Outcomes with Unknown Variance" Communications in

Statistics - Theory and Method, Vol. 21, 1992.

21. Shih, W.J. "On Informative and Random Dropouts in Longitudinal Studies" (Letter

to Editor), Biometrics, Vol. 28, 1992.

22. Shih, W.J. and Huang, W.M. "Evaluating Correlation With Proper Bounds"

Biometrics, 48, 1207-1213, 1992.

23. Peter J. Diggle and Weichung J. Shih “On Informative and Random Dropouts in

Longitudinal StudiesOn Informative and Random Dropouts in Longitudinal

Studies” Biometrics 1994 Correspondence pp. 947-949. Stable URL:

http://www.jstor.org/stable/2532217

24. Finasteride Study Group. "Finasteride (MK-906) in the Treatment of Benign

Prostatic Hyperplasia" The Prostate, 1993.

25. Shih, W.J. "Sample Size Reestimation for Triple Blind Clinical Trials" Drug

Information Journal, Vol. 27(3), 1993.

26. Williams, G., et al., Shih, W.J., et al. "Monitoring of Clinical Trials and interim

Analyses From a Drug Sponsor's Point of View" Statistics in Medicine, Vol. 12,

481-492, 1993.

27. Shih, W.J. "A Geometric Approach to the Analysis of Urinary Flow Data" Statistics

in Medicine, Vol. 13, 261-273, 1994.

28. Quan, H., Shih, W.J., Capizzi, T. "A Two-Stage Sequential Design and Analysis

For Comparing Binomial Rates with Possibly Random Dropouts" Communications

in Statistics (A)- Theory and Methods, Vol. 23(2), 467-484, 1994.

WJ SHIH CV of 26

29. Shih, W.J., Quan, H., Chang, M. "Estimation of the Mean When Data Contain Non-

ignorable Missing Values From a Random Effects Model" Statistics and

Probability Letters, VOL. 19, 249-257, 1994.

30. Garnero, P., Shih, W.J., Gineyts, L., Karpf, D.B. and Delmas, P.D. “Comparison of

New Biochemical Markers of Bone Turnover in Late Postmenopausal Osteoporotic

Women in Response to Alendronate Treatment” Journal of Clinical Endocrinology

and Metabolism, 79, 1693-1700, 1994.

31. Shih, W.J. and Gould, A.L. "Re-evaluation Design Specifications of Longitudinal

Clinical Trials Without Unblinding When the Key Response is Rate of Change"

Statistics in Medicine, Vol 14, 2239-48, 1995.

32. Quan, H. and Shih, W.J. "Assessing Reproducibility by the Within-Subject

Coefficient of Variation With Random Effects Models" Biometrics, Vol 52, 67-75,

1996.

33. Shih, W.J. and Quan, H. "Testing for Treatment Difference With Dropouts Present

in Clinical Trials -- A Composite Approach" Statistics in Medicine, Vol. 16, 1225-

1239, 1997.

34. Shih, W.J. and Zhao, P.L. “Design for Sample Size Re-estimation With Interim

Data for Double-Blind Clinical Trials With Binary Outcomes” Statistics in

Medicine, Vol 16, 1913-1923, 1997.

35. Shih, W.J. “Sample Size and Power Calculations for Periodontal and Other Studies

With Clustered Sample Using the Method of Generalized Estimating Equations”

Biometrical Journal, Vol 39. No. 8, 899-908, 1997.

36. Gould, A. L. and Shih, W.J. “Modifying the Design of Ongoing Trials Without

Unblinding” Statistics in Medicine, Vol 17, 89-100, 1998.

37. Shih, W.J. & Long, J. “Blinded Sample Size Re-estimation With Unequal

Variances and Center Effects in Clinical Trials” Communications in Statistics,

Theory & Method, Vol 27, No. 2, 395-408, 1998.

38. Chang, M.N., Hwang, I.K. & Shih, W.J. “Group Sequential Designs Using Both

Type I and Type II Error Probability Spending Functions” Communications in

Statistics -- Theory & Method, 27(6):1323-1339, 1998.

39. Shih, W.J. and Quan, H. “Stratified Testing of Treatment Effects With Missing

Data” Biometrics, 54:782-787, 1998.

40. Shih, W. J. and Quan, H. “Planning and Analysis of Repeated Measures at Key

Time-Points in Clinical Trials Sponsored by Pharmaceutical Companies” Statistics

in Medicine, 18:961-973, 1999.

41. Shih, W.J. “Commentary on Why Analysis of Variance is not for Multicenter

Clinical trials by David Salsburg” Controlled Clinical Trials, 20(5): 469-471, 1999.

42. Shih, W.J., Bachorik, P S., Haga, J A., Myers, G.L. and Stein E.A. “Estimating the

long term effects of storage at –700C on cholesterol, triglyceride and HDL-

cholesterol measurements in stored sera”, Clinical Chemistry, 46(3):351-364, 2000.

43. Cvijic, M.E. Kita, T., Shih, W.J., Dipaola, R.S., Chin, K.V. “Extracellular Catalytic

Subunit Activity of the cAMP-Dependent Protein Kinase in Prostate Cancer”,

Clinical Cancer research, 6:2309-2317, 2000.

44. Vita J. A., Yeung A., Shih, W. J. Mitchel, Y, and Ganz, P “Effect of Cholesterol-

Lowering Therapy on Coronary Endothelial Vasomotor Function in Patients with

Coronary Artery Disease” Circulation, 102(8):846-851, 2000.

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45. Shih, W.J. and Quan, H. “On the Composite Approach to Dropouts in Clinical

Trials” Statistica Sinica, 11:53-62, 2001.

46. Shih, W.J. “Sample size re-estimation – journey for a decade” Statistics in

Medicine, 20:515-518, 2001.

47. Wei, L. and Shih, W.J. “Partial Imputation Approach to Analysis of Repeated

Measurements With Dependent Dropouts” Statistics in Medicine, 20:1197-1214,

2001.

48. Yang, J. Iannone, M., Yang, J.M., Shih, W.J., Lin, Y., and Hait, W. “Disruption

of the EF-2 Kinase/Hsp90 Protein Complex: A Possible Mechanism to Inhibit

Glioblastoma by Geldanamycin” Cancer Research, 61:4010-4016, 2001.

49. Lin, Y. and Shih, W.J. “Statistical properties of the traditional algorithm-based

designs for phase-I cancer clinical trials” Biostatistics, 2:203-215, 2001.

50. Goydos, J.S., Patel, M., Shih, W.J. “NY-ESO-1 and CTp11 Expression May

Correlate with Stage of Progression in Melanoma” Journal of Surgical Research,

98:76-80, 2001.

51. Shih, W.J. “Clinical trials for drug registration in Asian regional countries: Proposal

for a new paradigm from a statistical perspective”, Controlled Clinical Trials,

22:357-366, 2001.

52. Lu, Y.P., Lou, Y.R., Lin, Y., Shih, W.J., Hung, M.T., Yang, C.S., Conney, A.H.

"Inhibitory Effects of Orally Administered Green Tea, Black Tea and Caffeine on

Skin Carcinogenesis in Mice Previously Treated with UVB (high Risk Mice):

Relationship to Decreased Tissue Fat", Cancer Research, 1,61:5002-5009, 2001.

53. Zheng, X., Chang, R.L., Cui, X.X., Kelly, K.A., Shih, W.J., Lin, Y., Strair, R., Suh,

J., Han, Z.T., Rabson, A., Conney, A.H. “Synergistic Effects of Clinically

Achievable Concentrations of 12-O-Tetradecanoylphorbol-13-acetate in

combination With all-trans Retinoic Acid, 1,25-Dihydroxyvitamin D3, and

Sodium Butyrate on Differentiation in HL-60 Cells. Oncology Research, 12: 419-

427, 2001.

54. DiPaola, R.S., Chenven, E.S., Shih, W.J., Lin, Y., Amenta, P., Goodin, S.,

Shumate, A., Rafi, M.M., Capanna, T., Cardiella, M., Cummings, K.B., and Todd,

M.B. "Mitoxantrone in patients with prostate specific antigen progression after local

therapy for prostate cancer", Cancer, 92, 2065-71, 2001.

55. Ankem, M.K., DeCarvalho, V.S., Harangozo, A.M., Hartanto, V.H., Perrotti, M.,

Han, K-R., Shih, W.J., Malka, E., White, E.C., Maggio, R., Ioffreda, R.,

Goldsmith, J.W., and Weiss, R.E. “Implications of radioactive seed migration to the

lungs after prostate brachytherapy”, Urology, 59:555-559, 2002.

56. Shih, W.J. “Problems in dealing with missing data and informative censoring in

clinical trials”, Current Controlled Trials in Cardiovascular Medicine 3:4, 1-24,

2002.

57. Chin, KV., Seifer, D., Feng, B., Lin, Y., Shih, W.J. “DNA microarray analysis

of the expression profiles of luteinized granulosa cells as a function of ovarian

reserve” Fertility and Sterility 77:1214-8, 2002.

58. Li, G., Shih, W.J., Xie, T. and Lu, J. “A sample size adjustment procedure for

clinical trials based on conditional power”, Biostatistics, 3, 2, 277-287, 2002.

59. Liu, A., Shih, W.J., and Gehan, E. “Sample size and power determination for

clustered repeated measurements” Statistics in Medicine, 21, 1787-1801, 2002.

WJ SHIH CV of 26

60. Bash-Babula, J., Toppmeyer, D., Labassi, M., Reidy, J., Orlick, M., Senzon, R.,

Alli, E., Kearney, T., Agust, D., Shih, W.J., Yang, J.M., Hait, W. “A phase

I/pilot study of sequential doxorubicin/vinorelbine: Effects of P53 and

microtubule-associated protein 4”, Cancer Clinical Research, 8, 1057-1064,

2002.

61. Zheng, X., Ravatn, R., Lin, Y., Shih, W.J., Rabson, A., Strair, R., Huberman,

E., Conney, A., Chin, K.V. “Gene expression of TPA induced differentiation in

HL-60 cells by DNA microarray analysis”, Nucleic Acids Research, 30:4489-

4499, 2002.

62. Lu, Y.P., Lou, Y.R., Li, X.H., Xie, J.G., Lin, Y., Shih, W.J., Conney, A.

“Stimulatory effect of topical application of caffeine on UVB-induced

apoptosis in mouse skin”, Oncology Research/Anti-Cancer Drug Design,

13:61-70, 2002.

63. Goydos, J.S., Patel, K. N., Shih, W.J., Lu, S.-E., Yudd, A.P., Kempf, J.S.,

Bancila, E., Germino, F.J. “Patterns of recurrence in patients with melanoma

and histologically negative but RT-PCR positive sentinel lymph nodes”.

Journal of the American College of Surgeons, 196:196-204, 2003.

64. Shih, W.J., Ouyang, P., Quan, H., Lin, Y., Michiels B. and Bijnens, L.

“Controlling type I error rate for fast track drug development programmes”.

Statistics in Medicine, 22:665-675, 2003.

65. Toppmeyer, D.L., Gounder, M., Much, J., Musanti, R., Lin, Y., Shih, W.J.,

Goodin, S., Rubin, E.H., “A phase I and pharmacologic study of the

combination of marimastat and paclitaxel in patients with advanced

malignancy”. Med Sci Monit, 9(8):PI 99-104, 2003.

www.MEDSCIMONT.com

66. Xie, W., Rimm, D.L., Lin, Y., Shih, W.J., Reiss, M. “Loss of Smad signaling

in human colorectal cancer is associated with advanced disease and poor

prognosis”, The Cancer Journal, 9(4):302-312, 2003.

67. Rodriguez-Rodriguez, L., Sanch-Torres, I., Mesonero, C., Gibson, D.G., Shih,

W.J., Zotails, G. “The DC44 receptor is a molecular predictor of survival in

ovarian cancer”. Medical Oncology, 20(3):255-263, 2003.

68. DiPaola, R., E. Rubin, D. Toppmeyer, J. Eid, D. Butzbach, D. Dvorzhinski, T.

Capanna, M. Cairdella, J. W. Shih, S. Goodin and M. B. Todd "Gemcitabine

combined with sequential paclitaxel and carboplatin in patients with urothelial

cancers and other advanced malignancies." Med Sci Monit 9(2): PI5-PI11,

2003.

69. Thalasila, A., Poplin, E., Shih, W.J., Goodin, S., Rubin, E., DiPaola, R.S. “A

phase I trial of weekly paclitaxel, 13-cis-retinoic acid, and interferon alpha in

patients with prostate cancer and other advanced malignancies.” Cancer

Chemother Pharmacol. 52:119-124, 2003.

70. Wong, Y. F. et al,, Shih, W.J., Chin, K. V., Hung T. K., Chung C.

“Expression genomics of cervical cancer: molecular classification and

prediction of radiotherapeutic response by DNA microarray.” Clinical cancer

Research, 9: 5486-5492, 2003.

http://www.medscimont.com/

WJ SHIH CV of 26

71. Alsina, J., Gorski, D.H., Germino, F.J., Shih, W., et. al, Hait, W.N., Goydos, J.S.

“Detection of mutations in the mitogen-activated protein kinase pathway in

human melanoma.” Clinical Cancer Research 9:6419-6425, 2003.

72. Zheng X., et al. Shih, W.J., Lin Y., Reuhl, K., Newmark, H., Rabson, A.,

Conney, A.H. “Inhibitory effect of 12-O-tetradecanoylphorbol-13-acetate alone

or in combination with all-trans-retinoic acid on the growth of LNCaP prostate

tumors in immunodeficient mice.” Cancer Research, 64:1811-1820, 2004.

73. Lu, S.-E., Lin, Y. and Shih, W.J. “Analyzing excessive no changes in clinical

trials with clustered data”. Biometrics, 60: 257-267, 2004.

74. He, W., Shih, W.J. “Use of joint models to assess treatment effects on disease

markers and clinical events: the Proscar Long-Term Efficacy and Safety Study

(PLESS).” Clinical Trials, 1:362-367, 2004.

75. Shih, W.J., Ohman-Strickland, P., Lin, Y. “Analysis of pilot and early phase

studies with small samples sizes.” Statistics in Medicine, 23:1827-1842, 2004.

76. Lin Y, Shih WJ “Adaptive two-stage designs for single-arm phase IIA cancer

clinical trials.” Biometrics, 60:482-490, 2004.

77. Liao J, Lin Y, Selvanayagam ZE, and Shih WJ “A Mixture Model for

Estimating the Local False Discovery Rate in DNA Microarray Analysis”,

Bioinformatics, 20: 2694-2701. 2004.

78. Shih WJ, Quan H, Li G “Two-stage adaptive strategy for superiority and non-

inferiority hypotheses in active controlled clinical trials” Statistics in Medicine,

23:2781-2798, 2004.

79. Chen X, et al., Lin Y, Shih WJ, Lubet R, Yang CS “Overexpression of 5-

Lipoxygenase in rat and human esophageal adenocarcinoma and inhibitory effects

of Zileuton and Celecoxib on carcinogenesis”, Clinical Cancer Research 10: 6703-

6709, 2004.

80. Chin KV, et al., Yang CS, Shih WJ “Application of expression genomics in drug

development and genomic medicine”, Drug Development Research 62:124-133,

2004.

81. Gao H, et al., Ouyang X, Lin Y, Shih WJ, et al., Shen M, Abate-Shen C “A

critical role for p27kip1

gene dosage in a mouse model of prostate carcinogenesis”,

Proc. National Academy of Sciences of the USA, 101, 49, 17204-09, 2004.

82. Zheng X., et al. Shih WJ, Lin Y., Chang R, Conney AH “Synergistic

stimulatory effect of 12-O-tetradecanoylphorbol-13-acetate and capsaicin on

macrophage differentiation in HL-60 and HL-525 human myeloid leukemia

cells” International Journal of Oncology, 26:441-448, 2005.

83. Goodin S, et al., Shih WJ, Todd M, DiPaola RS “Effect of docetaxel in

patients with hormone-dependent prostate-specific antigen progression after

local therapy for prostate cancer” Journal of Clinical Oncology, 23:3352-3357,

2005.

84. Li G, Shih WJ, Wang Y “Two-stage Adaptive Design for Clinical Trials With

Survival Data” Journal of Biopharmaceutical Statistics, 15:707-718, 2005.

85. Avila G., Zheng X, et. al. Shih WJ, et. al., Conney AH “Inhibitory effects of 12-O-

Tetradecanoylphorbol-13-acetate alone or in combination with all-tans retinoic acid

on the growth of cultured human pancreas cancer cells and pancreas tumor

WJ SHIH CV of 26

xenograpfts in immunodeficient mice” The J. of Pharmacology and Exp.

Therapeutics, 315:170-187, 2005.

86. Ju J., et al. Lin Y, Ma J., Shih WJ, Carothers AM, Yang CS, “Inhibition of

intestinal tumorigenesis in Apcmin/+ mice by (-)-epigallocatechin-3-gallate. the

major catechin in green tea. Cancer Res. 65(22):10623-31, 2005.

87. Shih W.J. “Commentary: Group sequential, sample size re-estimation and two-stage

adaptive designs in clinical trials: a comparison" Statistics in Medicine, 25:933-

941, 2006.

88. Greenawalt DM, Cui X, et al, Shih WJ, Lange K., Li H. “Strong correlation

between meiotic crossovers and haplotype structure in a 2.5-Mb region on the long

arm of chromosome 21” Genome Research, 16:208-214, 2006.

89. Zheng X, et. al., Shih WJ, Lin Y., Lu SE, Rabson AB, Kong ANT., Conney AH,

“Effects of 12-O-Tetradecanoylphorbol-13-acetate (TPA) in Combination with

Paclitaxel (Taxol) on Prostate Cancer LNCaP Cells Cultured In vitro or Grown as

Xenograft Tumors in ImmunodeficientMice”, Clin Cancer Res, 12(11): 3444-3451,

2006.

90. Michna L., Wagner G.C., et al., Lin Y., Carlson K., Shih WJ, Conney A H, and Lu

YP “Inhibitory effects of voluntary running wheel exercise on UVB-induced skin

carcinogenesis in SKH-1 mice”, Carcinogenesis, 27(10): 2108-2115, 2006.

91. Shih W.J. “Plan to be Flexible: A commentary on adaptive designs”, Biometrical

Journal, 48, 4, 656-659, 2006.

92. Li H., et. al., Lin Y., et. al., Shih W.J. “Microarray analysis of a large number of

single nucleotide polymorphisms in individual human spermatozoa”. In: The

Genetics of Male Infertility pp55-76. D. T. Carrell (ed.), Totowa, New Jersey

Humana Press, 2006.

93. Lu Y.P., et al., Lin Y., Shih WJ, and Conney A.H. “Caffeine and caffeine

sodium benzoate have a sunscreen effect, enhance UVB-induced apoptosis, and

inhibit UVB-induced skin carcinogenesis in SKH-1 mice”, Carcinogenesis,

28(1): 199-206, 2007.

94. Wu Y., Shih W.J., and Moore D.F. “Estimating a Survival Curve With Unlinked

Entry and Failure Times”, Statistics in Medicine, 26:3624-3638, 2007.

95. Zheng X, et al., Shih W.J., Lin Y., et al., Conney A.H. “Atorvastatin and Celecoxib

Inhibit Prostate PC-3 Tumors in Immunodeficient Mice", Clinical Cancer

Research, 13 (18), 5480-5487, 2007.

96. Shih W.J. “Two-stage sample size reassessment using perturbed unblinding”,

Statistics in Biopharmaceutical Research, on-line ready, 2007.

http://www.amstat.org/publications/sbr/index.cfm?fuseaction=papers

97. Liu J. et al., Harner J. , Shih WJ. “Is subcellular localization informative for

modeling protein-protein interaction signal?” Research Letters in Signal

Processing, Article ID 365152, 5 pages doi:10.1155/2008/365152.

http://www.hindawi.com/journals/rlsp/volume-2008/

98. Zheng X, et al. Shih WJ, Lin Y, et al Conney AH. “Inhibitory effect of

voluntary running wheel exercise on the growth of human pancreatic Panc-1 and

prostate PC-3 xenograft tumors in immunodeficient mice”, Oncology Reports

19: 1583-1588, 2008.

http://www.amstat.org/publications/sbr/index.cfm?fuseaction=papers

http://www.hindawi.com/journals/rlsp/volume-2008/

WJ SHIH CV of 26

99. Wu Y, Shih WJ , Moore, DF “Elicitation of a Beta prior for Bayesian

inference in clinical trials” Biometrical Journal 50 (2008) 2, 212–223 DOI:

10.1002/bimj.200710390.

100. Saraiya B, Gounder B, et al. Lin Y, Shih WJ, Aisner J, Strair RK, Rubin EH

“Sequential topoisomerase targeting and analysis of mechanisms of resistance to

topotecan in patients with acute myelogenous leukemia”, Anti-Cancer Drugs.

19(4):411-420, April 2008.

101. Lu-Yao G, Albertsen PC, Moore DF, Shih WJ, Lin, Y, DiPaola RS, Yao SL.

“Survival following primary androgen deprivation therapy among men with

localized prostate cancer”, J. American Medical Association, 300(2):173-181,

2008.

102. Ouyang X, et al., Lin Y, Shih WJ, et al., Abate-Shen C. “Activator protein-1

transcription factors are associated with progression and recurrence of prostate

cancer”, Cancer Res. 68(7):2132-44, 2008.

103. Wu Y and Shih WJ “Approaches to handling data when a phase II trial

deviates from the pre-specified Simon’s two-stage design”, Statistics in

Medicine; 27:6190–6208, 2008.

104. Chu P-L, Lin Y, Shih WJ “Unifying CRM and EWOC designs for phase I

cancer clinical trials”, Journal of Statistical Planning and Inference, 2008

doi:10.1016/j.jspi.2008.07.005.

105. Quan, H, Sun Q, Zhang J, Shih WJ “Comparisons between ITT and treatment

emergent adverse event analyses” Statistics in Medicine. 27(26): 5356-5376,

2008.

106. Liu J, Chen L, Zhao H, Moore DF, Lin Y, and Shih WJ “On calculating the

probability of s set of orthologous sequences” Computational Biology and

Chemistry: Advances and Applications 2009:2 37-48.

107. Shih WJ and Liu J “A simple method for screening binary models with large

sample size and continuous predictor variables”. Journal of Data Science, 2009:

7(4), 513-536.

108. Lu YP, Lou YR, Xie JG, Peng QY, Zhou S, Shih WJ, Lin Y, Conney AH.

“Tumorigenic effect of some commonly used moisturizing creams when applied

topically to UVB-pretreated high-risk mice.” Journal of Investigative

Dermatology. 2009;129(2):468-475.

109. Shao YH , Demissie K, Shih WJ, Mehta AR, Stein MN, Roberts CB, DiPaola

RS, Lu-Yao GL. “Contemporary Risk Profile of Prostate Cancer in the United

States”, J Natl Cancer Inst 101:1280–1283, 2009.

110. Lu-Yao, GL, Albertsen PC, Moore, DF, Shih, WJ, Lin, Y, DiPaola, RS, Barry,

MJ,Zietman A, O’Leary M, Walker-Corkery E, and Yao S-L. “Outcomes of

localized prostate cancer following conservative management.” J. American

Medical Association, 2009; 302(11):1202-1209.

111. Yip, D.; Le, MN; Chan, J. L.; Lee, JH; Mehnert, JM; Yudd, A.; Kempf, J.;

Shih,WJ; Chen, S; Goydos, JS. “A phase 0 trial of riluzole in patients with

resectable stage III and IV melanoma.” Clin Cancer Res 2009; 15:3896-3902.

112. Blumer JL, Findling RL, Shih WJ, Soubrane C, Reed MD. “Controlled clinical

trial of zolpidem for the treatment of insomnia associated with attention-deficit/

http://www.ncbi.nlm.nih.gov/pubmed?term=Blumer%20JL%5BAuthor%5D&cauthor=true&cauthor_uid=19403468

http://www.ncbi.nlm.nih.gov/pubmed?term=Findling%20RL%5BAuthor%5D&cauthor=true&cauthor_uid=19403468

http://www.ncbi.nlm.nih.gov/pubmed?term=Shih%20WJ%5BAuthor%5D&cauthor=true&cauthor_uid=19403468

http://www.ncbi.nlm.nih.gov/pubmed?term=Soubrane%20C%5BAuthor%5D&cauthor=true&cauthor_uid=19403468

http://www.ncbi.nlm.nih.gov/pubmed?term=Reed%20MD%5BAuthor%5D&cauthor=true&cauthor_uid=19403468

WJ SHIH CV of 26

hyperactivity disorder in children 6 to 17 years of age.” Pediatrics. 2009

May;123(5):e770-6.

113. Zheng X, Cui X. X, Gao Z, Zhao Y, Lin Y, Shih WJ, Huang MT, Liu Y,

Rabson AB, Reddy B, Yang CS, Conney AH. “Atorvastatin and celecoxib in

combination inhibits the progression of androgen-dependent LNCaP xenograft

prostate tumors to androgen independence.” Cancer Prev Res (Phila Pa) (2010)

3:114-124.

114. Liu J, Lin Y, Shih WJ “On Simon's two-stage design for single-arm phase IIA

cancer clinical trials under Beta-binomial distribution” Statistics in Medicine.

2010 Jan 14. [Epub ahead of print].

115. Luo X, Shih WJ, Ouyang SP, DeLap RJ. An optimal adaptive design to address

local regulations in global clinical trials. Pharmaceutical Statistics 2010; 9:179-

189.

116. Wang Y, Li, G, Shih WJ “Estimation and confidence intervals for two-stage

sample-size-flexible design with LSW likelihood approach” Statistics in

Biosciences, 2010; 2:180-190.

117. Zheng X. Cui X, Gao X, Zhao, Y, Shi Y, Huang MT, Liu Y, Wagner GC, Lin

Y, Shih WJ, Rao CV, Yang CS and Conney AH. Inhibitory effect of dietary

atorvastatin and celecoxib together with voluntary running wheel exercise on

the progression of androgen-dependent LNCaP prostate tumors to androgen

independence. Experimental and Therapeutic Medicine 2011; 2: 221-228.

118. Albertsen PC, Moore DF, Shih WJ, Lin Y, Li H and Lu-Yao G. Impact of

Comorbidity on survival among men with localized prostate cancer. Journal of

clinical oncology, 2011; 29, 1335-1341.

119. Li G. et al, Lin Y, Shih WJ, Yang C.S “d-Tocopherol is more active than a- or

g-Tocopherol in inhibiting lung tumorigenesis in vivo”. Cancer Prev Res;

2011; 4:404-413.

120. Lou Y-R, Peng Q-Y, et al Medvecky CM, Lin Y, Shih WJ, Conney AH, et al, et

al and Lu Y-P. Effects of high-fat diets rich in either omega-3 or omega-6 fatty

acids on UVB-induced skin carcinogenesis in SKH-1 mice. Carcinogenesis

2011; 32:1078–1084.

121. Mehnert JM, Tan AR, et al. Lin Y, Shih WJ, et al. Karantza. “Rationally

Designed Treatment for Solid Tumors with MAPK Pathway Activation: A

Phase I Study of Paclitaxel and Bortezomib Using an Adaptive Dose-Finding

Approach”, Molecular Cancer Therapeutics, 2011:10:1509-1519.

122. Kim S, Shen S, Moore DF, Shih WJ, Lin Y, Li H, Dolan M, Shao Y-H, Lu-Yao

G. Late gastrointestinal toxicities following radiation therapy for prostate

cancer. European Urology, 2011:60 (5), 908–916.

123. Li G, et al, Lin Y, Shih WJ, Yang C.S. “The antioxidant and anti-inflammatory

activities of tocopherols are independent of Nrf2 in mice”. Free Radical Biology

& Medicine 52 (2012) 1151–1158.

124. Guan F., et al, Lin Y., Shih WJ, Yang C.S. “d- and g-Tocopherols, but not a-

Tocopherol, inhibit colon carcinogenesis in Azoxymethane-treated F344 rats”.

Cancer Prevention Research. OnlineFirst on February 24, 2012;

DOI:10.1158/1940-6207.CAPR-11-0521.

http://www.ncbi.nlm.nih.gov/pubmed?term=((Blumer%5BAuthor%20-%20Last%5D)%20AND%20Shih%5BAuthor%20-%20Last%5D)%20AND%20Reed%20M%5BAuthor%5D

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125. Lu-Yao, G, Albertsen PC, Li

, H, Moore, DF, Shih WJ, Lin Y, DiPaola RS, Yao

SL. “Does Primary Androgen-Deprivation Therapy Delay the Receipt of

Secondary Cancer Therapy for Localized Prostate Cancer?” European Urology

Available online 10 May 2012. http://dx.doi.org/10.1016/j.eururo.2012.05.003.

126. Luo X., Li M., Shih WJ, Ouyang P. “Estimation of Treatment Effect Following

a Clinical Trial with Adaptive Design”, Journal of Biopharmaceutical Statistics,

22:4 (2012), DOI: 0.1080/10543406.2012.676534; 2012.

127. Lu YP, et al., Lin Y, Shih WJ, et al., Wagner GC, and Conney AH (2012),

“urgical removal of the parametrial fat pads inhibits UVB-induced skin

carcinogenesis in obese mice”, PNAS May 21, 2012, doi:

10.1073/pnas.1205810109.

128. Little R.J., Cohen M.L., Dickersin K., Emerson S.S., Farrar J.T., Neaton J.D.,

Shih, WJ., Siegel J.P. and Stern H. (2012), “The design and conduct of clinical

trials to limit missing data” Statist. In Med. July 2012. doi: 10.1002/sim.5519.

129. Little RJ, et al., Shih WJ, Siegel JP, and Stern H. “The Prevention and

Treatment of Missing Data in Clinical Trials”, N Engl J Med 2012; 367:1355-

1360 October 4, 2012. DOI: 10.1056/NEJM sr1203730.

130. Smolarek AK, et al., Kong T, Reuh K, Lin Y, Shih WJ, et al, Yang CS, and

Suh N. “Dietary Administration of d- and g-Tocopherol Inhibits Tumorigenesis

in the Animal Model of Estrogen Receptor–Positive, but not HER-2 Breast

Cancer”. Cancer Prev Res 2012; 5(11); 1310–20.

131. Dong, G, Shih, WJ, Moore, D, Quan, H, Marcella, S (2012) A Bayesian-

frequentist two-stage single-arm phase II clinical trial design. Statistics in

Medicine, in press. DOI: 10.1002/sim.5330.

132. Chang RL, Wood AW, Huang MT, Xie JG, Cui XX, Reuhl KR, Boyd DR, Lin

Y, Shih WJ, et al, Conney AH (2013), Mutagenicity and tumorigenicity of the

four enantiopure bay-region 3,4-diol-1,2-epoxide isomers of

dibenz[a,h]anthracene, Carcinogenesis 2013; doi: 10.1093/carcin/bgt164.

133. Quan H, Li M, Shih WJ, Ouyang S.P, Chen J, Zhang J, Zhao PL “Empirical

shrinkage estimator for consistency assessment of treatment effects in multi-

regional clinical trials” Statist. In Med., 32 1691–1706, 2013.

134. Kim S, Moore DF, Shih W, Lin Y, Li H, Shao YH, Shen S, Lu-Yao GL (2013)

Severe genitourinary toxicity following radiation therapy for prostate cancer-

How long does it last? Journal of Urology 189, 116-121.

doi:10.1016/j.juro.2012.08.091.

135. Shao YH, Moore DF, Shih WJ, Lin Y, Jang TL, Lu‐Yao GL (2013) Fractures

after androgen deprivation therapy among men with a high baseline risk of

skeletal complications. BJU International 111, 745-752. DOI: 10.1111/j.1464-

410X.2012.11758.x

136. Shao YH J, Kim S, Moore DF, Shih WJ, Lin Y, Stein M, Kim IY, Lu-Yao GL

(2014) Cancer-specific survival after metastasis following primary radical

prostatectomy compared with radiation therapy in prostate cancer patients:

Results of a population-based propensity score-matched analysis. European

Urology http://dx.doi.org/10.1016/j.eururo.2013.05.023

http://dx.doi.org/10.1016/j.eururo.2012.05.003

http://dx.doi.org/10.1016/j.eururo.2013.05.023

WJ SHIH CV of 26

137. Quan H, Mao X, Chen J, Shih WJ, Ouyang SP, Zhang J, Zhao PL and

Binkowitz B (2014). Multi-regional clinical trial design and consistency

assessment of treatment effects. Statistics in Medicine 33: 2191–2205

138. Fang F, Lin Y, Shih WJ, Li Y, Yang J and Zhang X (2014). Methods of

designing two-stage winner trials with survival outcomes. Statist.in Med. 33:

1539–1563.

139. Lu-Yao GL, Albertsen PC, Moore DF, Shih WJ, Lin Y, DiPaola RS, and Yao

SL (2014). 15-Year Survival Outcomes Following Primary Androgen

Deprivation Therapy for Localized Prostate Cancer. JAMA Internal Medicine.

In Process.

140. Wu Y, Lin Y, Li CS, Lu SE, and Shih WJ (2014). Asymptotic efficiency of an

exponential cure model when cure information is partially known. International

Journal of Statistics and Probability

141. Wu Y, Lin Y, Lu SE, Li CS, and Shih WJ (2014). Extension of a Cox

proportional hazards cure model when cure information is partially known.

Biostatistics 15, 3, pp. 540–554. doi: 10.1093/biostatistics/kxu002

142. Song M, DiPaola R S, Cracchiolo B M, Gibbon D G, Hellmann M, Nieves-

Neira W, Vaidya A, Wagreich A R, Shih WJ, Rodriguez-Rodriguez L. Phase 2

Trial of Paclitaxel, 13-cis Retinoic Acid, and Interferon Alfa-2b in the Treatment

of Advanced Stage or Recurrent Cervical Cancer. Int J Gynecol Cancer,

2014;24: 1636-1641.

143. Bone HG, Dempster DW, Eisman JA, Greenspan SL, McClung MR, Nakamura

T, S. Papapoulos S, Shih WJ, Rybak-Feiglin A, Santora AC. Odanacatib for the

treatment of postmenopausal osteoporosis: development history and design and

participant characteristics of LOFT, the Long-Term Odanacatib Fracture Trial.

Osteoporosis International, 29 Nov 2014 DOI10.1007/s00198-014-2944-6

(B) Books, Monographs and Chapters

Textbook:

Shih WJ and Asiner J. (2015) “Statistical Design and Analysis of Clinical Trials:

Principles and Methods” Chapman &Hall/CRC Press, New York. Book Chapters; Book

Reviews; Other Professional Communications

Book Chapters:

1. Shih, W.J. "Sample Size Reestimation in Clinical Trials" in Biopharmaceutical

Sequential Statistical Analysis. Editor: K. Peace. Marcel-Dekker Inc., New York,

1992, pp. 285-301.

2. Shih, W. J. “Group Sequential Methods” Book Chapter, Encyclopedia of

Biopharmaceutical Statistics, Ed., S.C. Chow, Marcel-Dekker Inc., New York,

2000.

3. Shih, W.J. “Recent Statistical Issues and Developments in Cancer Clinical Trials”,

in Statistics in the Pharmaceutical Industry. 3rd edition. Editors: C. Ralph

Buncher and Jia-Teong Tsay. Chapman & Hall/CRC, New York, 2005.

WJ SHIH CV of 26

4. Shih, W.J. and Y. Lin “Traditional and Modified Algorithm-based Designs for

Phase I Cancer Clinical Trials”, in Statistical Methods for Dose-Finding Studies.

Editor: Sylvie Chevret, John Wiley, 2006.

5. Li, H., Cui, X., Greenawalt, D. M., et al., Lin, Y., et al., and Shih, W. J.

“Microarray Analysis of a Large Number of Single Nucleotide Polymorphisms in

Individual Human Spermatozoa”, in: The Genetics of Male Infertility pp55-76.

Editor: D. T. Carrell, Totowa, New Jersey: Humana Press, 2006

6. Shih,WJ. Clinical Trials Handbook. Editor: Jonathan T. Rose, Wiley-Blackwell,

John Wiley & Sons, Inc. 2009

7. Shih, WJ and Quan, H. “Consistency of Treatment Effects in Bridging Studies and

Global Multiregional Trials” in Design and Analysis of Bridging Studies (Chapter

3.) Editors: Jen-pei Liu , Shein-Chung Chow , and Chin-Fu Hsiao

Chapman and Hall/CRC 2012 Print ISBN: 978-1-4398-4634-6; eBook ISBN:

978-1-4398-4635-3. 2012

Abstracts (Only partial recording)

1. Cirillo, V.J.; Till, A.E.; Gomez, H.J.; Shih, W.J.; and Thieme, G. "Effect of Age on

Lisinopril Pharmacokinetics." (Abstract) American Society for Clinical Pharmacology

and Therapeutics Conference, Washington, DC, March 1985.

2. Nalin, D.R.; Hart, C.; Shih, W.J.; and Aziz, M. "Multicenter Open Clinical Trial of

Imipenem Therapy of Serious Pediatric Infections." (Abstract) Interscience Conference

on Antimicrobial Agents and Chemotherapy, Minneapolis, MN, October 1985.

3. Gomez, H.J.; Otterbein, E.S.; Warner, N.J.; Shih, W.J.; and Moncloa, F. "Efficacy of

Lisinopril in Elderly Patients With Congestive Heart Failure." (Abstract) III World

Conference on Clinical Pharmacology and Therapeutics, Stockholm, Sweden, July 1986.

4. Aziz, M.A.; Jacobsen, C.A.; Harman, R.; Neu, D.; Ko, A.; Shih, W.J. "Efficacy and

Safety of Ivermectin Vs. Diethylcarbamazine (DEC) in the Treatment of

Onchocerciasis." (Abstract) Chemotherapy 15-th International Congress, Istanbul,

Turkey, July 1987.

5. Smith, S.G.; Gomez, H.J.; Shih, W.J. "Efficacy of Lisinopril in Elderly Hypertensive

Patients." (Abstract) American Society of Clinical Pharmacology and Therapeutics. San

Diego, CA, September 1987.

6. Shih, W.J., Gould, L.A. "Analysis of Lens Opacity Data in Clinical Studies Using

Methods Accounting for Classification Errors." (Abstract) International Society for

Clinical Biostatistics, Gothenburg, Sweden, September 1987.

7. Dyke T.V., Ryder, M, Shih, W.J., et.al. “Safety of Once-Weekly Alendronate 70 mg in

Periodontal Disease”, Academy for Periodontal Research Conference, May, 2000.

8. D. Adams, R. Genco, M. Jeffcoat, P. Klokkevold, R. Page, G. Cizza, M. Kimberlin, A.

Lombardi, L. Meng, A. Santora, and W. J. Shih, for the Alendronate Periodontal Study

Group. “Safety and Tolerability of Once-Weekly Alendronate 70 mg is Comparable to

that of Placebo in Men and Women with Periodontal Disease”, . American Society for

Bone and Mineral Research, Toronto, Canada, September 22-26, 2000.

9. Rodrigues Lorna, Sancho-Torres, Ines, Gibbon, D., Malka, E. and Shih, W.J. “CD44

receptor is a molecular predictor of survival in ovarian cancer’, Society of Gynecologic

Oncology, October, 2000.

WJ SHIH CV of 26

10. Shih, W.J. “Statistical Issues in Extension Studies”, International Biometrics Society

ENAR Meeting, Virginia, March 20-24, 2002.

11. Shih, W.J., Bauer, D.C., Orloff, J., Capizzi, T., Thompson, D., Oppenheimer, L., Ross,

P.D. “ Proportion of Fracture Risk Reduction Explained By BMD Changes Using

Freedman Analysis Depends On Choice Of Predictors”, Third International Symposium

on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis, Barcelona, Spain,

November 6-9, 2002.

12. Goodin, S., Shih, W.J., Kane, M., DiPaola, R.S. “Clinical and biological activity of soy

protein power (SPP) in healthy male volunteers: Effect on testosterone and luteinizing

hormon”, Proceedings of the American Society of Clinical Oncology, New Orleans, LA,

June 5-8, 2004.

13. MK Jeffcoat, G. Cizza, W. J. Shih, R.Genco and A. Lombardi “Efficacy of

bisphophonates for the control of alveolar bone loss in periodontitis” ASBMR meeting,

2006.

14. L. Rodriguez-Rodriguez, N. Muthukumaran, S. Goodin, G. Frenkel, P. Caffrey, D. G.

Gibbon, W. Nieves-Neira, A. Vaidya, W. Shih, E. H. Rubin “Serum CD44 levels

correlate with response to selenium based therapy in patients with gynecologic cancers”

ASCO Annual Meeting, Chicago, May30-June 3 2008.

15. M. A. Sovak, L. Guensch, P. Joyce, S. Lutzker, S. Schwartz, W. J. Shih, L. Zheng, J.

Aisner “A phase II trial of weekly cisplatin and docetaxel in advanced non-small cell

lung cancer (NSCLC) - final report” ASCO Annual Meeting, Chicago, May30-June 3

2008.

16. A. Mehta, R. Anand, M. N. Stein, W. J. Shih, S. Goodin, R. S. DiPaola “Long-term

outcome of patients treated with docetaxel for hormone-dependent prostate-specific

antigen (PSA) progression after local therapy for prostate cancer” ASCO Annual

Meeting, Chicago, May30-June 3 2008.

17. R. S. DiPaola, M. Stein, S. Goodin, S. Eddy, E. Rubin, S. Doyle-Lindrud, D.

Dvorzhinski, S. Beers, W. J. Shih, E. White; “Warburg science goes to the bedside: A

phase I trial of 2-deoxyglucose in patients with prostate cancer and advanced

malignancies”, ASCO Annual Meeting, Chicago, May30-June 3 2008.

18. S. Yao, D. F. Moore, W. Shih, Y. Lin, R. S. DiPaola, P. C. Albertsen, G. L. Lu-Yao;

“Survival following primary androgen deprivation therapy among men with localized

prostate cancer”, ASCO Annual Meeting, Chicago, May30-June 3 2008.

19. Shih, WJ “Go or No-go decision for phase III cancer clinical trials”, Education session,

AACR Annual Meeting, San Diego, April 2008.

Proceedings:

1. Shih, W. J.; Ko, A. "Fitting Loglinear Models Using SAS Software" Proceedings of

Tenth Annual SAS Users Group International Conference, March, 1985.

2. Shih, W.J. "An Overview of Some Issues in Designing Clinical Trials for Prevention

of Chronic Diseases" Proceedings of the Biopharmaceutical Section of the American

Statistical Association 1989, p. 242-247.

3. Liu, M., Peszek, I. and Shih, W.J. “Practitioner’s perspective on using multiple

imputation with Solas in clinical trials”, American Statistical Association 1999 Joint

Meetings, Proceedings, BioPharmaceutical Section, 2000.

WJ SHIH CV of 26

Letter to the Editor/Discussion:

4. Shih, W. J. "Thrombocytosis: not enough data to make judgment" Journal of

Diagnostic Microbiology and Infectious Disease, 1986; 4:89-90.

5. Shih, W.J. "On Informative and Random Dropouts in Longitudinal Studies"

(Correspondence Reply), Biometrics, 48, 2, 1992, p. 970-971.

6. Shih, W.J. "On Informative and Random Dropouts in Longitudinal Studies"

(Correspondence Reply), Biometrics, 49, 3, 1993, p. 947-949.

7. Shih, W.J. Discussion on Diggle and Kenward "Informative Drop-out in

Longitudinal Data Analysis" Applied Statistics (JRSS-C), Vol. 43 (1), 87, 1994.

8. Shih, W.J. and Quan, H. "Testing for Treatment Difference With Dropouts Present

in Clinical Trials -- A Composite Approach” Statistics in Medicine, Vol. 16, 1225-

1239, 1997.” (Correspondence Reply), Statistics in Medicine, Vol. 17, 1063-1064,

1998.

9. Quan, H. and Shih, W.J. "Assessing Reproducibility by the Within-Subject

Coefficient of Variation With Random Effects Models” Biometrics, Vol. 52, 67-75,

1996." (Correspondence Reply), Biometrics, 1998.

Book Review

10. Shih, W.J. Book review on “Drug stability --Principles and Practices” International

Society for Clinical Biostatistics News, No. 22, p. 21, April 1997.

11. Shih, W.J. "Statistical Methodology in The Pharmaceutical Sciences" - Book

Review, Statistics in Medicine, Vol. 9, 1990.

Invited Talks at professional societies, academic departments, government agencies

(1989-2005)

1. "An Overview of Some Issues In Designing Prevention Studies for Chronic Diseases"

The Eastern North America Region of the Biometric Society Annual Meeting,

Kentucky, March 1989.

2. "Analysis of Titration Studies in Phase III Clinical Trials" Pharmaceutical

Manufacturers Association, Biostatistics Subsection Annual Meeting, Tempe,

Arizona, October 1989.

3. "Interim Analyses for Sample Size Reestimation Without Unblinding Treatment

Group Identification in Double-Blind Clinical Trials" Society for Clinical Trials

Annual Meeting, Toronto, Canada, May 1990.

4. "Recent Development in Design and Analysis for Prevention Trials" Department of

Mathematics and Statistics, Lehigh University, 1991.

5. "Sample Size Reestimation in Clinical Trials" Drug Information Society Meeting,

Hilton Head Island, S.C., March 1992.

6. "A Geometric Approach to the Analysis of Urinary Flow Data" Biometric Society

Spring Meeting, Cincinnati, OH, March 1992.

7. "Import Issues in Designing Prevention Trials" First Great Lake Applied Statistics

Symposium, Kalamazoo, MI, June 1992.

8. "Estimation of the Mean With Incomplete Data With Measurement Error"

Department of Biostatistics, School of Public Health, Columbia University, October

1992.

WJ SHIH CV of 26

9. "Re-evaluating Specifications of Longitudinal Clinical Trials Without Unblinding

When the Key Response is Rate of Change" The Biometric Society Spring Meeting,

Philadelphia, PA, March 1993.

10. "Inference on the Mean When Data Contain Informative Missing Values" Department

of Statistics, Rutgers University, N.J. December, 1993.

11. "Using Slopes as an Outcome Measure in Clinical Trials" The Society for Clinical

Trials Annual Meeting, Houston, May, 1994.

12. "Principles of Ignorability of Missing Values and Applications" (With Daniel Heitjan)

The 50th Deming Conference on Applied Statistics, American Society for Quality

Control and American Statistical Association, Atlantic City, December, 1994.

13. "Sample Size Re-estimation in Clinical Trials" Division of Biometrics, Food and

Drug Administration, January, 1995.

14. "Statistics in Pharmaceutical Industry" International Chinese Statistical Association

Annual Conference, Beijing, 1995.

15. "Adaptive Design for Clinical Trials With Continuous Variable as Main Outcome"

International Statistical Institute, Beijing, 1995.

16. “Post-randomization Comparisons -- Problem Recognition and Alternative Analysis”

Society for Clinical Trials, 17th Annual Meeting, Pittsburgh, PA, May, 1996

17. “Two-Stage Flexible Design in Clinical Trials, Continuous and Binary Cases”

Applied Statistics Conference, International Chinese Statistical Association, Johns

Hopkins University, Baltimore, MD, June 7-9, 1996.

18. “Sample Size Re-estimation in Clinical Trials, Review and New Developments”

Department of Statistics, University of Minnesota, Minneapolis-St. Paul, June 21-22,

1996.

19. “Sequential Designs and Sample Size Re-estimation Methods in Clinical Trials”

International Biometric Society, ENAR Regional Spring Meeting, Memphis, March

1997.

20. “Sample Size Re-estimation for Triple Blind Clinical Trials -- Review & New

Developments” Short Course, Applied Statistics Conference, International Chinese

Statistical Association, Rutgers University, May 30, 1997.

21. “A Two Stage Design For Sample Size Re-estimation With Binary Outcomes” Joint

Research Conference on Statistics in Industry and Technology, New Brunswick, NJ.,

June 2-4, 1997.

22. “Current Statistical Issues in Design and Analysis of Clinical Trials” Special Lecture,

National Science Council, Taiwan, R.O.C. June 9-14, 1997.

23. “Sample Size Re-estimation and Conditional Power for Clinical Trials” Workshop at

52nd Annual Deming Conference on Applied Statistics, American Society for Quality

Control and American Statistical Association, Atlantic City, NJ, December 5, 1997.

24. “Planning and Analysis of Repeated Measures at Key Time-Points in Clinical Trials

Sponsored by Pharmaceutical Companies” Biometrics ENAR Meeting, March 30,

1998.

25. "Testing for Treatment Difference With dropouts Present in clinical Trials--A Pattern

but Not Mixture Approach" European Drug Information Association, Amsterdam,

The Netherland, April 22, 1998.

26. “Analysis of Repeated Measures - The Industrial Viewpoint” International Chinese

Statistical Association, Gorton, Connecticut, June 6, 1998.

WJ SHIH CV of 26

27. “Interim Analysis and Sample Size re-estimation” The Food & Drug Administration

Statistics Workshop, October 22, 1998.

28. “A Hybrid of Modified CRM and EWOC approaches for Phase I Cancer Trials”

(Shih, W. J., Lee, J. J. and Lin, Y.) International Biometrics Society ENAR Spring

Meetings, Atlanta, Georgia, March 28-31, 1999.

29. “Analysis of Biomarker Modulation in Multiple Biopsy Data” (Lee, J. J., Shih, W. J.

and Liu, D.) International Biometrics Society ENAR Spring Meetings, Atlanta,

Georgia, March 28-31, 1999.

30. Contrasting Characteristics of Clinical Trials Sponsored by Government Versus

Industry” (Chair & Discussant), Society for Clinical Trials 20th Annual Meeting,

Anaheim, California, May 2-5, 1999.

31. “Meta-Analysis and Trial Reporting” (Chair & Discussant), Society for Clinical Trials

20th Annual Meeting, Anaheim, California, May 2-5, 1999.

32. “Practical Experience and Viewpoint on Multiple Imputation Methods for Clinical

Trials” (Chair & Discussant), Joint Meetings of American Statistical Association,

Baltimore, Maryland, August 8-12, 1999.

33. “Issues in the Analysis of data With Missing Values in Clinical Trials”,

Biopharmaceutical Section of American Statistical Association and the Food and

Drug Administration Statistical Association, Arington, Virginia, September 30 –

October 1, 1999.

34. “Partial Imputation and Pattern-but-not-Mixed Approaches for Dropouts in Clinical

Trials”, International Biometric Society ENAR Meeting, Chicago, Ill, March 19-21,

2000.

35. “Intention-To-Treat: What and How in the Presence of Dropouts in Clinical Trials”,

Drug Information Association Annual Meeting, San Diego, CA, June 11-15, 2000.

36. “Latest Advance in Design and Analysis of Cancer Trials”, Recent Advancement in

Biopharmaceutical Statistics Workshop, National Health Research Institute, Taiwan,

December 15-16, 2000

37. “Statistical Issues in the FDA’s Fast-Track Approval Program”, Euro-DIA Meeting,

Barcelona, Spain, March 18-23, 2001.

38. “A Sample Size Adjustment Procedure by Conditional Power Approach",

International Biometric Society ENAR Meeting, March 25-28, 2001.

39. “Clinical trials for drug registration in Asia-Pacific Region - Proposal for consistency

Trials", Symposium on statistical Methodology for Evaluation of Bridging Evidence,

Taipei, Taiwan (ROC), May 23-27, 2001.

40. “ICH-E5: Ethnicity Considerations in Acceptability of Foreign data", ASA New

Jersey Chapter Spring Symposium, Piscataway, New Jersey. June 6, 2001.

41. “Adaptive Statistical Design for Clinical Trials", Drug Information Association

Annual Meetings, Denver, CO, July 7-9, 2001.

42. “Statistical Issues in Extension Studies”, International Biometrics Society ENAR

Meeting, Virginia, March 20-24, 2002.

43. “Principles in Design of Clinical Trials”, Aventis, Evidenced Medicine group,

Bridgewater, NJ, October 2003.

44. “Adaptive Designs of Clinical Trials”, Pfizer Global Research & Development, New

London, CT, April 6, 2004.

WJ SHIH CV of 26

45. “Global drug development and bridging study strategies: three scenarios”,

International Chinese Statistical Association, Singapore, July 2004.

46. “Analysis of data with excessive no-change with clustered structure in clinical trials”

International Biometrics Society, Cairns, Australia, July 2004.

47. “Group sequential, sample size re-estimation and two-stage adaptive designs in

clinical trials: a comparison" The US Food and Drug Administration, April 12, 2005.

(Stopped recording after 2005)

date: may 2000 - rutgers university · 2019-06-24 · invited workshop session chair and organizer...

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