Activity Number
|
Title
|
Sponsor(s)
|
Type
|
Date/Time/Location
|
|
CE_08C
|
Analysis of Clinical Trials: Theory and Applications
|
Biopharmaceutical Section
|
Continuing Education Course
|
Sun, 8/1
8:30 AM to
5:00 PM
Room: CC-1 (East)
|
| |
|
13
|
* !
Key Applications of Statistics in Genetics/Genomics
|
Biopharmaceutical Section
Biometrics Section
ENAR
International Chinese Statistical Association
|
Topic Contributed Papers
|
Sun, 8/1
2:00 PM to
3:50 PM
Room: CC-114/115 (West)
|
| |
|
17
|
*
Pharmaceutical Stability Shelf Life: Philosophy, Intent, and Estimation
|
Biopharmaceutical Section
ENAR
|
Topic Contributed Papers
|
Sun, 8/1
2:00 PM to
3:50 PM
Room: CC-210 (West)
|
| |
|
18
|
* !
Bayesian and Adaptive Design Applications in Early Phase Clinical Trials
|
Biopharmaceutical Section
ENAR
Section on Bayesian Statistical Science
Statistical Programmers and Analysts
|
Topic Contributed Papers
|
Sun, 8/1
2:00 PM to
3:50 PM
Room: CC-110 (West)
|
| |
|
47
|
*
Statistical Issues in Approval of Follow-On Biologics
|
Biopharmaceutical Section
ENAR
|
Invited Papers
|
Sun, 8/1
4:00 PM to
5:50 PM
Room: CC-223 (West)
|
| |
|
57
|
*
Statistical Methods for Assessing Anti-Tumor Activity
|
Biopharmaceutical Section
Biometrics Section
ENAR
|
Topic Contributed Papers
|
Sun, 8/1
4:00 PM to
5:50 PM
Room: CC-209 (West)
|
| |
|
60
|
*
Adaptive Designs: How Flexible Are They?
|
Biopharmaceutical Section
ENAR
|
Topic Contributed Papers
|
Sun, 8/1
4:00 PM to
5:50 PM
Room: CC-220 (West)
|
| |
|
61
|
*
Statistical Methods in Medical Device Studies
|
Biopharmaceutical Section
ENAR
|
Topic Contributed Papers
|
Sun, 8/1
4:00 PM to
5:50 PM
Room: CC-218/219 (West)
|
| |
|
62
|
Design and Analysis of Thorough QTc Clinical Trials
|
Biopharmaceutical Section
ENAR
|
Topic Contributed Papers
|
Sun, 8/1
4:00 PM to
5:50 PM
Room: CC-214 (West)
|
| |
|
72
|
*
Applications of Survival Analyses in Clinical Trials
|
Biopharmaceutical Section
Biometrics Section
Section on Risk Analysis
|
Contributed Papers
|
Sun, 8/1
4:00 PM to
5:50 PM
Room: CC-222 (West)
|
| |
|
73
|
*
Various Topics in Clinical Trials
|
Biopharmaceutical Section
|
Contributed Papers
|
Sun, 8/1
4:00 PM to
5:50 PM
Room: CC-208 (West)
|
| |
|
206180
|
Biopharmaceutical Section Executive Committee Meeting
|
Biopharmaceutical Section
|
Other Cmte/Business
|
Mon, 8/2
7:30 AM to
12:30 PM
Room: CC-106 (West)
|
| |
|
107
|
* !
Clinical Trials and Informative Decisionmaking
|
Committee on Applied Statisticians
Biopharmaceutical Section
|
Invited Papers
|
Mon, 8/2
8:30 AM to
10:20 AM
Room: CC-120 (West)
|
| |
|
113
|
*
Latest Discoveries in Statistical Methods of Evaluating Surrogate Endpoints in Clinical Trials
|
Biopharmaceutical Section
Committee on Applied Statisticians
ENAR
|
Topic Contributed Papers
|
Mon, 8/2
8:30 AM to
10:20 AM
Room: CC-213 (West)
|
| |
|
115
|
*
Development of Combinations of Molecularly Targeted Agents in Oncology
|
Biopharmaceutical Section
|
Topic Contributed Papers
|
Mon, 8/2
8:30 AM to
10:20 AM
Room: CC-215 (West)
|
| |
|
117
|
*
Multiregional Drug Development: Asking the Right Questions and Getting the Right Answers
|
Biopharmaceutical Section
ENAR
|
Topic Contributed Papers
|
Mon, 8/2
8:30 AM to
10:20 AM
Room: CC-202 (West)
|
| |
|
126
|
* !
Diagnostic Accuracy and Agreement
|
Biometrics Section
Biopharmaceutical Section
|
Contributed Papers
|
Mon, 8/2
8:30 AM to
10:20 AM
Room: CC-206 (West)
|
| |
|
128
|
*
Bayesian Analysis of Clinical Trial Data
|
Biopharmaceutical Section
Section on Bayesian Statistical Science
ENAR
|
Contributed Papers
|
Mon, 8/2
8:30 AM to
10:20 AM
Room: CC-212 (West)
|
| |
|
129
|
*
Use of Linear Mixed Models and Generalized Estimating Equations in Clinical Trials
|
Biopharmaceutical Section
|
Contributed Papers
|
Mon, 8/2
8:30 AM to
10:20 AM
Room: CC-203 (West)
|
| |
|
130
|
Interim Analyses and Assessments of Futility
|
Biopharmaceutical Section
|
Contributed Papers
|
Mon, 8/2
8:30 AM to
10:20 AM
Room: CC-204 (West)
|
| |
|
155
|
*
Doing Better Than Average: Tailored Therapeutics in Drug Development
|
Biopharmaceutical Section
|
Invited Panel
|
Mon, 8/2
10:30 AM to
12:20 PM
Room: CC-306 (West)
|
| |
|
171
|
*
Innovative Analysis Strategies in Clinical Trials
|
Biopharmaceutical Section
ENAR
|
Contributed Papers
|
Mon, 8/2
10:30 AM to
12:20 PM
Room: CC-204 (West)
|
| |
|
172
|
*
Applications of Nonlinear Models and Nonlinear Curve Fitting
|
Biopharmaceutical Section
ENAR
|
Contributed Papers
|
Mon, 8/2
10:30 AM to
12:20 PM
Room: CC-205 (West)
|
| |
|
198
|
Biopharmaceutical Section P.M. Roundtable Discussion (fee event)
|
Biopharmaceutical Section
|
Roundtables PM Roundtable Discussion
|
Mon, 8/2
12:30 PM to
1:50 PM
Room: CC-Ballroom D (West)
|
| |
|
221
|
* !
Adaptive Designs in Phase II and Phase III Trials: Current State of the Science
|
Biopharmaceutical Section
Section for Statistical Programmers and Analysts
|
Topic Contributed Papers
|
Mon, 8/2
2:00 PM to
3:50 PM
Room: CC-306 (West)
|
| |
|
225
|
*
Design and Analysis of Bioassay Experiments
|
Biopharmaceutical Section
WNAR
|
Topic Contributed Papers
|
Mon, 8/2
2:00 PM to
3:50 PM
Room: CC-220 (West)
|
| |
|
226
|
*
Use of Multiple Testing Procedures in Clinical Trials in Regulatory Applications
|
Biopharmaceutical Section
IMS
|
Topic Contributed Papers
|
Mon, 8/2
2:00 PM to
3:50 PM
Room: CC-223 (West)
|
| |
|
227
|
*
Statistical Considerations in the Design and Conduct of Medical Device Studies
|
Biopharmaceutical Section
ENAR
|
Topic Contributed Papers
|
Mon, 8/2
2:00 PM to
3:50 PM
Room: CC-218/219 (West)
|
| |
|
238
|
Biomarkers
|
Biopharmaceutical Section
|
Contributed Papers
|
Mon, 8/2
2:00 PM to
3:50 PM
Room: CC-302/303 (West)
|
| |
|
239
|
Meta-Analysis and Analysis of Adverse Events
|
Biopharmaceutical Section
ENAR
|
Contributed Papers
|
Mon, 8/2
2:00 PM to
3:50 PM
Room: CC-217 (West)
|
| |
|
256
|
Contributed Oral Poster Presentations: Biopharmaceutical Section
|
Biopharmaceutical Section
|
Contributed Poster Presentations
|
Mon, 8/2
2:00 PM to
3:50 PM
Room: CC-Exhibit Hall A (West)
|
| |
|
273
|
* !
Future Directions in Biopharmaceutical Statistics
|
Biopharmaceutical Section
CHANCE
ENAR
|
Invited Papers
|
Tue, 8/3
8:30 AM to
10:20 AM
Room: CC-301 (West)
|
| |
|
283
|
* !
Joint Modeling of Time-to-Event and PROs in Oncology Clinical Trials
|
Biopharmaceutical Section
|
Topic Contributed Papers
|
Tue, 8/3
8:30 AM to
10:20 AM
Room: CC-207 (West)
|
| |
|
289
|
*
Challenging Statistical Issues in Medical Device Trials
|
Biopharmaceutical Section
|
Topic Contributed Papers
|
Tue, 8/3
8:30 AM to
10:20 AM
Room: CC-215 (West)
|
| |
|
324
|
* !
CDISC: Standards vs. Operational Challenges
|
Section for Statistical Programmers and Analysts
Biopharmaceutical Section
|
Invited Papers
|
Tue, 8/3
10:30 AM to
12:20 PM
Room: CC-121 (West)
|
| |
|
328
|
*
Meta-Analysis Related to Regulatory Issues: The FDA Guidance Document for Diabetes and Cardiovascular Risk
|
Biopharmaceutical Section
ENAR
Health Policy Statistics Section
|
Topic Contributed Papers
|
Tue, 8/3
10:30 AM to
12:20 PM
Room: CC-215 (West)
|
| |
|
329
|
*
The Design and Analysis of Crossover Trials: Some Recent Developments
|
Biopharmaceutical Section
|
Topic Contributed Papers
|
Tue, 8/3
10:30 AM to
12:20 PM
Room: CC-302/303 (West)
|
| |
|
330
|
* !
Safety Signal Detection in a New Drug Development Program
|
Biopharmaceutical Section
Committee on Applied Statisticians
|
Topic Contributed Papers
|
Tue, 8/3
10:30 AM to
12:20 PM
Room: CC-122 (West)
|
| |
|
332
|
* !
Adaptive Design for Drug/Diagnostic Combination Trials
|
Biopharmaceutical Section
ENAR
|
Topic Contributed Papers
|
Tue, 8/3
10:30 AM to
12:20 PM
Room: CC-209 (West)
|
| |
|
344
|
*
Missing Data in Clinical Trials
|
Biopharmaceutical Section
ENAR
|
Contributed Papers
|
Tue, 8/3
10:30 AM to
12:20 PM
Room: CC-207 (West)
|
| |
|
345
|
*
Survival Analysis
|
Biopharmaceutical Section
Section on Risk Analysis
|
Contributed Papers
|
Tue, 8/3
10:30 AM to
12:20 PM
Room: CC-206 (West)
|
| |
|
365
|
Biopharmaceutical Section P.M. Roundtable Discussion (fee event)
|
Biopharmaceutical Section
|
Roundtables PM Roundtable Discussion
|
Tue, 8/3
12:30 PM to
1:50 PM
Room: CC-Ballroom D (West)
|
| |
|
391
|
*
Missing Data in Clinical Trials
|
Biopharmaceutical Section
|
Topic Contributed Papers
|
Tue, 8/3
2:00 PM to
3:50 PM
Room: CC-218/219 (West)
|
| |
|
393
|
*
Biosimilarity for Follow-On Biologics
|
Biopharmaceutical Section
|
Topic Contributed Papers
|
Tue, 8/3
2:00 PM to
3:50 PM
Room: CC-217 (West)
|
| |
|
394
|
*
Statistical Issues in Multiregional and Bridging Trials
|
Biopharmaceutical Section
ENAR
|
Topic Contributed Papers
|
Tue, 8/3
2:00 PM to
3:50 PM
Room: CC-220 (West)
|
| |
|
395
|
*
Design and Analyses of Vaccine Trials for Evaluating Correlates of Protection
|
Biopharmaceutical Section
Biometrics Section
|
Topic Contributed Papers
|
Tue, 8/3
2:00 PM to
3:50 PM
Room: CC-205 (West)
|
| |
|
407
|
*
Multiple Comparisons or Statistical Significance
|
Biometrics Section
Biopharmaceutical Section
|
Contributed Papers
|
Tue, 8/3
2:00 PM to
3:50 PM
Room: CC-221 (West)
|
| |
|
408
|
*
Adaptive Designs
|
Biopharmaceutical Section
|
Contributed Papers
|
Tue, 8/3
2:00 PM to
3:50 PM
Room: CC-222 (West)
|
| |
|
409
|
Multiplicity in Clinical Trials
|
Biopharmaceutical Section
ENAR
|
Contributed Papers
|
Tue, 8/3
2:00 PM to
3:50 PM
Room: CC-209 (West)
|
| |
|
206181
|
Biopharmaceutical Section Annual Business Meeting and Mixer
|
Biopharmaceutical Section
|
Other Cmte/Business
|
Tue, 8/3
5:30 PM to
7:00 PM
Room: CC-209 (West)
|
| |
|
444
|
*
Handling of Missing Data in Clinical Trials: Findings of a National Research Council Study
|
Biopharmaceutical Section
Committee on Applied Statisticians
ENAR
Section for Statistical Programmers and Analysts
|
Invited Papers
|
Wed, 8/4
8:30 AM to
10:20 AM
Room: CC-220 (West)
|
| |
|
454
|
*
Evidence Synthesis in Drug Development
|
Biopharmaceutical Section
|
Topic Contributed Papers
|
Wed, 8/4
8:30 AM to
10:20 AM
Room: CC-222 (West)
|
| |
|
468
|
*
Evaluation of QT/QTc Studies and Bioequivalence
|
Biopharmaceutical Section
|
Contributed Papers
|
Wed, 8/4
8:30 AM to
10:20 AM
Room: CC-221 (West)
|
| |
|
469
|
*
Topics in Clinical Trials
|
Biopharmaceutical Section
|
Contributed Papers
|
Wed, 8/4
8:30 AM to
10:20 AM
Room: CC-216 (West)
|
| |
|
498
|
*
Covariate-Adaptive Randomization and Associated Analyses
|
Biopharmaceutical Section
|
Topic Contributed Papers
|
Wed, 8/4
10:30 AM to
12:20 PM
Room: CC-214 (West)
|
| |
|
501
|
* !
Statistical Methods for Handling Early Study Medication Discontinuations in a Time-to-Event Noninferiority Trial
|
Biopharmaceutical Section
Committee on Applied Statisticians
Section for Statistical Programmers and Analysts
|
Topic Contributed Papers
|
Wed, 8/4
10:30 AM to
12:20 PM
Room: CC-218/219 (West)
|
| |
|
503
|
*
Applications of Bayesian Methodology to Clinical Trials in Oncology
|
Biopharmaceutical Section
Committee on Applied Statisticians
ENAR
Section on Bayesian Statistical Science
|
Topic Contributed Papers
|
Wed, 8/4
10:30 AM to
12:20 PM
Room: CC-220 (West)
|
| |
|
504
|
* !
Statistical Methods in Clinical Trial Monitoring
|
Biopharmaceutical Section
Committee on Applied Statisticians
ENAR
|
Topic Contributed Papers
|
Wed, 8/4
10:30 AM to
12:20 PM
Room: CC-217 (West)
|
| |
|
513
|
*
Vaccine Trials
|
Biopharmaceutical Section
|
Contributed Papers
|
Wed, 8/4
10:30 AM to
12:20 PM
Room: CC-203 (West)
|
| |
|
514
|
*
Dose Finding/Dose Response
|
Biopharmaceutical Section
Section on Risk Analysis
|
Contributed Papers
|
Wed, 8/4
10:30 AM to
12:20 PM
Room: CC-202 (West)
|
| |
|
515
|
*
Genomics
|
Biopharmaceutical Section
|
Contributed Papers
|
Wed, 8/4
10:30 AM to
12:20 PM
Room: CC-122 (West)
|
| |
|
541
|
Biopharmaceutical Section P.M. Roundtable Discussion (fee event)
|
Biopharmaceutical Section
|
Roundtables PM Roundtable Discussion
|
Wed, 8/4
12:30 PM to
1:50 PM
Room: CC-Ballroom D (West)
|
| |
|
554
|
* !
Bayesian Methods in Pharmaceutical Development and Clinical Research
|
ENAR
Biopharmaceutical Section
Section on Bayesian Statistical Science
Section for Statistical Programmers and Analysts
|
Invited Papers
|
Wed, 8/4
2:00 PM to
3:50 PM
Room: CC-306 (West)
|
| |
|
565
|
!
Statistical Issues in Pharmaceutical Neuroimaging
|
Biopharmaceutical Section
IMS
|
Topic Contributed Papers
|
Wed, 8/4
2:00 PM to
3:50 PM
Room: CC-221 (West)
|
| |
|
566
|
*
Challenges and Methods for Evaluating Diagnostic Devices and Medical Device Software
|
Biopharmaceutical Section
|
Topic Contributed Papers
|
Wed, 8/4
2:00 PM to
3:50 PM
Room: CC-213 (West)
|
| |
|
569
|
!
Methods, Practical Experiences, and Strategies for Adaptive Design Clinical Trials
|
Biopharmaceutical Section
Section for Statistical Programmers and Analysts
|
Topic Contributed Papers
|
Wed, 8/4
2:00 PM to
3:50 PM
Room: CC-220 (West)
|
| |
|
583
|
*
Statistical Strategies for Oncology Trials
|
Biopharmaceutical Section
|
Contributed Papers
|
Wed, 8/4
2:00 PM to
3:50 PM
Room: CC-117 (West)
|
| |
|
584
|
*
Analysis of Composite Endpoints, Surrogate Endpoints, and Multicenter Trials
|
Biopharmaceutical Section
ENAR
|
Contributed Papers
|
Wed, 8/4
2:00 PM to
3:50 PM
Room: CC-120 (West)
|
| |
|
598
|
* !
Adaptive Design: Balancing Between Hype and Hope
|
ENAR
Biopharmaceutical Section
|
Invited Papers
|
Thu, 8/5
8:30 AM to
10:20 AM
Room: CC-209 (West)
|
| |
|
620
|
Data Analysis Issues in Medical Device Studies
|
Biopharmaceutical Section
ENAR
|
Topic Contributed Papers
|
Thu, 8/5
8:30 AM to
10:20 AM
Room: CC-212 (West)
|
| |
|
622
|
*
Clinical Trial Design
|
Biometrics Section
Biopharmaceutical Section
|
Contributed Papers
|
Thu, 8/5
8:30 AM to
10:20 AM
Room: CC-114 (West)
|
| |
|
625
|
Analysis Techniques for Crossover Trials
|
Biopharmaceutical Section
|
Contributed Papers
|
Thu, 8/5
8:30 AM to
10:20 AM
Room: CC-217 (West)
|
| |
|
626
|
*
Sample Size Determination and Re-estimation
|
Biopharmaceutical Section
|
Contributed Papers
|
Thu, 8/5
8:30 AM to
10:20 AM
Room: CC-105/106 (West)
|
| |
|
627
|
*
Statistical Strategies Applied Across Therapeutic Areas
|
Biopharmaceutical Section
ENAR
|
Contributed Papers
|
Thu, 8/5
8:30 AM to
10:20 AM
Room: CC-107/108 (West)
|
| |
|
645
|
*
Key Multiplicity Issues in Clinical Trials
|
Biopharmaceutical Section
Committee on Applied Statisticians
ENAR
|
Invited Papers
|
Thu, 8/5
10:30 AM to
12:20 PM
Room: CC-301 (West)
|
| |
|
663
|
!
Design, Analysis, and Operational Considerations of Adaptive Design Trials in Clinical Development
|
Biopharmaceutical Section
Committee on Applied Statisticians
ENAR
|
Topic Contributed Papers
|
Thu, 8/5
10:30 AM to
12:20 PM
Room: CC-222 (West)
|
| |
|
665
|
*
Considerations in Safety Data Analyses
|
Biopharmaceutical Section
|
Topic Contributed Papers
|
Thu, 8/5
10:30 AM to
12:20 PM
Room: CC-114 (West)
|
| |
|
667
|
*
Ordinal Data
|
Biometrics Section
Biopharmaceutical Section
|
Contributed Papers
|
Thu, 8/5
10:30 AM to
12:20 PM
Room: CC-107/108 (West)
|
| |
|
669
|
*
Analysis Strategies for Count Data, Data with Excessive Zeros, and Sparse Data
|
Biopharmaceutical Section
|
Contributed Papers
|
Thu, 8/5
10:30 AM to
12:20 PM
Room: CC-113 (West)
|
| |
|
670
|
*
Evaluation of Methodology Using Simulations
|
Biopharmaceutical Section
|
Contributed Papers
|
Thu, 8/5
10:30 AM to
12:20 PM
Room: CC-111 (West)
|
| |
- A * preceding a session name means that the session is an applied session.
- A ! preceding a session name means that the session reflects the JSM meeting theme.
|