Tuesday, August 6

Session and

Room

Time

Speaker, Session and Talk Title

TA1-I

Lalique

8:30-10:10

Adaptive Designs II Session Chair: G. Chi (FDA)

8:30-9:00

G. Lan (Pfizer): Repeated significance tests in adaptive sequential designs (Invited Talk)

9:00-9:20

Q. Liu (J&J Pharmaceutical R& D): Multiplicity and the choice of alpha-spending in two-stage designs

9:20-9:40

J. Lawrence (FDA): Changing the test statistic after an interim analysis

9:40-10:00

Q. Li* and M. Huque (FDA): A general multiplicity adjustment approach and its application to evaluating several independently conducted studies

10:00-10:10

Discussion

TA1-II

Waterford

8:30-10:10

MCPs for Interactions, Session Chair: C. Hirotsu (Meisei Univ.)

8:30-9:00

M. Aoshima (Univ. of Tsukuba): Sample size determination for multiple comparisons with components of a linear function of mean vectors (Invited Talk)

9:00-9:20

C. Hirotsu (Meisei Univ.): Comparing subjects according to their time profiles based on repeated measurements

9:20-9:40

L. Hothorn (Univ. of Hannover): Demonstration of interlaboratory similarity of dose-response assays by modification of interaction contrasts

9:40-10:00

K. Ghosh*, S. Li (Merck): Multiple comparison procedures in testing qualitative interaction

10:00-10:10

Discussion

---

10:10-10:30

Coffee Break

TA2-I

Lalique

10:30-12:10

Multiplicity Issues in Clinical Trials: Challenges From the Regulatory Point of View. Session Chair: K. Mahjoob (FDA)

10:30-11:00

R. Sridhara*, G. Chen, K. He and G. Chi (FDA): Problem of alpha adjustment in studies with multiple primary endpoints - Evaluation of relationship between endpoints (Invited Talk)

11:00-11:20

P. Yang*, G. Chen, and G. Chi (FDA): Controlling the false positive rate due to multiple analyses

11:20-11:40

G. Chen*, Y-C Wang, and G. Chi (FDA): Multiplicity issues in sample size re-estimation for active control non-inferiority trials

11:40-12:00

T-H Ng (FDA): Issues of simultaneous tests for non-inferiority and superiority

12:00-12:10

Discussion

TA2-II

Waterford

10:30-12:10

Computing for MCPs, Session Chair: P. Somerville (Univ. of Central Florida)

10:30-11:00

F. Bretz* (Univ. of Hannover) and P. Westfall: Power of closed test procedures (Invited Talk)

11:00-11:20

T. Miwa* (National Institute for Agro-Environmental Sciences, Tsukuba, JAPAN), T. Hayter and S. Kuriki: The efficient evaluation of multi-normal distribution functions

11:20-11:40

P.  Somerville* (Univ. of Central Florida) and F. Bretz: Stepup and stepdown multiple hypotheses testing for the correlated case

11:40-12:00

A. Gill* and P. Singh (Panjab Univ.): Sample quasi ranges-based class of one sided tests and related multiple comparisons

12:00-12:10

Discussion

---

12:10-1:30

Lunch Break

TP1-I

Lalique

1:30-3:00

MCPs for Efficacy and Safety Testing, Session Chair: M. Huque (FDA)

1:30-1:50

J. Heyse* and D. Mehrotra (Merck): Multiplicity considerations in clinical safety analyses

1:50-2:10

S. Basu (N. Illinois Univ.): Multiplicity in clinical safety data

2:10-2:30

E. Biesheuvel* (Organon NV) and L. Hothorn: Protocol-designed subgroup analysis in multi-armed clinical trials: multiplicity aspects

2:30-2:50

D. Bristol* and N. Stouffer (Purdue Pharma LP): A stepwise maximum modulus test with unequal variances

2:50-3:00

Discussion

TP1-II

Waterford

1:30-3:00

MCPs for Comparisons with Controls, Session Chair: B. Logan (Medical College of Wisconsin)

1:30-1:50

E. Solorzano and N. Dasgupta* (Washington State Univ.): Comparing multiple treatments to a positive control, in the presence of a negative control

1:50-2:10

S-H Cheung* (Chinese University of Hong Kong) and K.S. Kwong: Multiple comparisons with a control in families with both one-sided and two-sided hypotheses

2:10-2:30

M. Horn* (Institute of Medical Statistics,  Jena, Germany), and C. Dunnett: Power and sample size comparisons of some FWE and FDR controlling step-down and step-up procedures in the many-one case

2:30-2:50

C. Dunnett (McMaster Univ.): Drug screening and the false discovery rate

2:50-3:00

Discussion

---

3:00-3:30

Coffee Break

TP2-I

Lalique

3:30-5:10

FDA/Industry Panel Discussion, Session Chair: P. Westfall (Texas Tech Univ.): R. O’Neill (FDA), George Chi (FDA), N. Geller (NHLBI), David Jordan (Pharmacia/Upjohn), Surya Mohanty (Johnson & Johnson), Larry Gould (Merck), Peter Bauer (Univ. of Vienna), and Chen-Sheng Lin (Bristol-Myers Squibb).  A discussion of multiplicity aspects in a "real" Phase III clinical trial.  The goal is to develop some degree of consensus among industry, government, and academic statisticians concerning requirements and methods for multiplicity management in typical clinical trials.   There will be plenty of time for questions, comments, and discussion from panelists and from the audience.

TP2-II

Waterford

3:30-5:10

Model Fitting and Simultaneous Inference, Session Chair: Y. Benjamini (Tel Aviv Univ.)

3:30-4:00

R. Beran (Univ. of California, Davis):Multiple Comparisons for Smoothed Fits to One-and Two-way Layouts (Invited Talk)

4:00-4:30

I. Johnstone* (Stanford Univ.), Y. Benjamini, F. Abramovich and D. Donoho: False discovery rates and the estimation of sparse normal means (Invited Talk)

4:30-4:45

S. Kuriki (Institute of Statistical Mathematics): Limiting null distribution of the Jones-Sibson projection pursuit index and its approximation by the tube formula

4:45-5:00

D. Donoho and J. Jin* (Stanford Univ.): Optimal adaptivity of Tukey`s higher criticism

5:00-5:10

Discussion

Wednesday, August 7

Session and

Room

Time

Speaker, Session and Talk Title

WA1-I

Lalique

8:30-10:10

Analysis of DNA-Microarray Assays, Session Chair: N. Geller (NHLBI)

8:30-9:00

R. Simon (NIH): Multiple comparison issues in the design and analysis of studies of DNA Microarray Gene Expression Profiles (Invited Talk)

9:00-9:20

K. Pollard* and M. van der Laan (Univ. of California, Berkeley): Parametric and nonparametric methods to identify significantly differentially expressed genes

9:20-9:40

S. Kropf* (Otto von Guericke Univ.),  J. Läuter, M. Eszlinger: Multiple comparisons with gene expression arrays using a data driven ordering of hypotheses

9:40-10:00

G. Pennello (FDA): Screening for genes with differential expression in microarray experiments: A Bayesian subset selection approach

10:00-10:10

Discussion

WA1-II

Waterford

8:30-10:10

MCPs in Simulation Experiments and Monte Carlo Methods, Session Chair: B. Nelson (Northwestern Univ.)

8:30-9:00

D. Goldsman (Georgia Tech): Random walk methods for analyzing the performance of Bernoulli and multinomial selection procedures (Invited Talk)

9:00-9:20

B. Nelson (Northwestern Univ.): Asymptotic analysis of a fully sequential selection procedure for steady-state simulation

9:20-9:40

J. Boesel (The MITRE Corp.): Combinations of subset selection and indifference-zone procedures to select the best of a large number of systems

9:40-10:00

J. Opdyke (Economic Consulting Group): Fast two-sample permutation tests, even when one sample is large, that efficiently maximize power under conventional Monte Carlo sampling

10:00-10:10

Discussion

---

10:10-10:30

Coffee Break

WA2-I

Lalique

10:30-12:10

Foundations, Bayesian Methods and Novel Approaches, Session Chair: H. Finner (Deutsches Diabetes-Forschungsinstitut, Abteilung Biometrie und Epidemiologie)

10:30-11:00

J. Shaffer (Univ. of California, Berkeley): Is the null hypothesis ever true?  Correspondence between beliefs and multiple comparison procedures (Invited Talk)

11:00-11:20

J. Chen* and S. Sarkar  (Merck) A Bayesian Approach to Stepwise Simultaneous Testing

11:20-11:40

C. Lewis* and D. Thayer (ETS): Multiple inferences for random effects

11:40-12:00

Q. Liu (J&J Pharmaceutical R& D): On the SMART principles for multiple comparisons

12:00-12:10

Discussion

WA2-II

Waterford

10:30-12:10

Selection Procedures and Screening Experiments, Shanti S. Gupta Memorial Session, Session Chair: J. Hsu (Ohio State Univ.)

10:30-11:00

G. Giani*, H. Finner and K. Strassburger (Univ. of Duesseldorf): Subset selection of good populations: Partitioning principle, power control, and software (Invited Talk)

11:00-11:20

G. Pan and T. Santner* (Ohio State Univ.): Screening Procedures to Identify Robust Product Designs Based on General Combined-Array Experiments

11:20-11:40

W. Wang and D. Voss* (Wright State Univ.): Control of error rates in adaptive analysis of saturated factorial designs

11:40-12:00

S. Gupta and D. Li* (Merck): On empirical Bayes procedures for selecting good populations in positive exponential family

12:00-12:10

Discussion

---

12:10-1:30

Lunch Break

WP1-I

Lalique

1:30-3:00

Multiple Dose Studies and Other Problems, Session Chair: N. Dasgupta (Washington State Univ.)

1:30-1:50

L. Shen (Sanofi-Synthelabo Research): A new method to evaluate drug effect in a multiple dose clinical trial

1:50-2:10

V. Berger (NCI): Improving the information content of clinical trial endpoints

2:10-2:30

P. Somerville* (Univ. of Central Florida) and W. Liu: Stepwise multiple tests for successive comparison of treatment effects

2:30-2:50

J-W Choi* and B. Nandram (NCHS/CDC): Measure of similarity between two groups with common variables

2:50-3:00

Discussion

WP1-II

Waterford

1:30-3:00

Genomics, Session Chair: L. Hothorn (Univ. of Hannover)

1:30-1:50

J. Troendle (NIH): Controlling the false discovery proportion or the number of false discoveries with application to high-dimensional genomic data

1:50-2:10

J. Rogers*, J. Hsu and S. Lin (Cereon Genomics): Applying the partitioning principle to genome scans

2:10-2:30

C. Sabatti*, S. Service and N. Freimer (Univ. of California, Los Angeles): False discovery rate and correction for multiple comparisons in linkage disequilibrium genome screens

2:30-2:50

J. Chen and H. Hsueh* (National ChengChi Univ.): Estimating the number of true null hypotheses in multiple testing problems Discussion