JSM 2015 Preliminary Program

Activity Number	Title	Sponsor(s)	Type	Location
CE_08C	Adaptive Methods for Modern Clinical Trials (ADDED FEE)	ASA Biopharmaceutical Section	Professional Development Continuing Education Course	Sun, 8/9 8:30 AM to 5:00 PM Room: S-Grand Ballroom A
15	* ! Novel Computational Approaches in Drug Safety Surveillance	Biopharmaceutical Section Biometrics Section	Topic Contributed Papers	Sun, 8/9 2:00 PM to 3:50 PM Room: CC-612
16	* Exploring Bayesian Approaches in Drug Clinical Trials	Biopharmaceutical Section Section on Bayesian Statistical Science International Society for Bayesian Analysis (ISBA) International Chinese Statistical Association Biometrics Section	Topic Contributed Papers	Sun, 8/9 2:00 PM to 3:50 PM Room: CC-611
42	Adaptive Design 1	Biopharmaceutical Section Biometrics Section	Contributed Papers	Sun, 8/9 2:00 PM to 3:50 PM Room: CC-620
44	! Statistical Issues Specific to Therapeutic Areas I	Biopharmaceutical Section Section for Statistical Programmers and Analysts Biometrics Section	Contributed Papers	Sun, 8/9 2:00 PM to 3:50 PM Room: CC-619
45	Topics in Clinical Trials 1	Biopharmaceutical Section Biometrics Section	Contributed Papers	Sun, 8/9 2:00 PM to 3:50 PM Room: CC-618
60	* ! Advanced Multiple Testing Methodologies for Confirmatory Trials	Biopharmaceutical Section ENAR	Topic Contributed Papers	Sun, 8/9 4:00 PM to 5:50 PM Room: CC-4C4
62	* ! Challenges and Opportunities for Enrichment Design of Clinical Trials	Biopharmaceutical Section Biometrics Section	Topic Contributed Papers	Sun, 8/9 4:00 PM to 5:50 PM Room: CC-612
85	Biomarkers and Endpoint Validation 1	Biopharmaceutical Section Biometrics Section	Contributed Papers	Sun, 8/9 4:00 PM to 5:50 PM Room: CC-611
86	* ! Clinical Trial Design 1	Biopharmaceutical Section Biometrics Section	Contributed Papers	Sun, 8/9 4:00 PM to 5:50 PM Room: CC-620
88	Topics in Clinical Trials 2	Biopharmaceutical Section Biometrics Section	Contributed Papers	Sun, 8/9 4:00 PM to 5:50 PM Room: CC-619
212205	Biopharmaceutical Section Executive Committee Meeting (Closed)	Biopharmaceutical Section	Other Cmte/Business	Mon, 8/10 7:30 AM to 12:30 PM Room: S-Metropolitan A
CE_12C	Concepts and Implementation of Bayesian Adaptive Phase I Oncology Trials (ADDED FEE)	ASA Biopharmaceutical Section	Professional Development Continuing Education Course	Mon, 8/10 8:00 AM to 12:00 PM Room: S-Grand Ballroom A
118	* Statistical Challenges in Clinical Trials of Novel Vaccines	Biopharmaceutical Section Biometrics Section	Topic Contributed Papers	Mon, 8/10 8:30 AM to 10:20 AM Room: CC-608
144	! Novel Design and Statistical Modeling in Early Development of Oncology Drugs	Biopharmaceutical Section Biometrics Section	Contributed Papers	Mon, 8/10 8:30 AM to 10:20 AM Room: CC-610
145	Adaptive Design II	Biopharmaceutical Section	Contributed Papers	Mon, 8/10 8:30 AM to 10:20 AM Room: CC-617
CE_14C	Analysis of Clinical Trials: Theory and Applications (ADDED FEE)	ASA Biopharmaceutical Section	Professional Development Continuing Education Course	Mon, 8/10 8:30 AM to 5:00 PM Room: S-Grand Ballroom D
160	* ! Statistical Methods in Drug Safety from Clinical Trial to Post-Market	Biopharmaceutical Section Government Statistics Section Biometrics Section	Invited Papers	Mon, 8/10 10:30 AM to 12:20 PM Room: CC-3B
164	* ! Subgroup Analyses: How Friendly Are They?	Biopharmaceutical Section Section for Statistical Programmers and Analysts	Topic Contributed Papers	Mon, 8/10 10:30 AM to 12:20 PM Room: CC-3A
191	Biomarkers and Endpoint Validation II	Biopharmaceutical Section Biometrics Section	Contributed Papers	Mon, 8/10 10:30 AM to 12:20 PM Room: CC-310
192	! Noninferiority Studies	Biopharmaceutical Section	Contributed Papers	Mon, 8/10 10:30 AM to 12:20 PM Room: CC-308
206	Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee)	Biopharmaceutical Section	Roundtables PM Roundtable Discussion	Mon, 8/10 12:30 PM to 1:50 PM Room: CC- Ballroom 6E
231	* ! Recent Research in Adaptive Randomized Trials to Address Challenges in Regulatory Science	Biopharmaceutical Section Section on Medical Devices and Diagnostics	Topic Contributed Papers	Mon, 8/10 2:00 PM to 3:50 PM Room: CC-607
232	* ! Adaptive Multi-Stage Clinical Trials with Unblinded Sample Size Re-Estimation: Overview, Recent Development in Methods, and Their Implementation	Biopharmaceutical Section Biometrics Section	Topic Contributed Papers	Mon, 8/10 2:00 PM to 3:50 PM Room: CC-609
259	! Clinical Trial Design II	Biopharmaceutical Section Biometrics Section	Contributed Papers	Mon, 8/10 2:00 PM to 3:50 PM Room: CC-613
260	Missing Data II	Biopharmaceutical Section Government Statistics Section	Contributed Papers	Mon, 8/10 2:00 PM to 3:50 PM Room: CC-614
281	Biopharmaceutical Section A.M. Roundtable Discussion (Added Fee)	Biopharmaceutical Section	Roundtables AM Roundtable Discussion	Tue, 8/11 7:00 AM to 8:15 AM Room: CC- Ballroom 6E
290	* ! Estimands and Their Role in Clinical Trials: Defining Suitable Primary Scientific Questions of Interest	Biopharmaceutical Section Biometrics Section Section on Medical Devices and Diagnostics	Invited Papers	Tue, 8/11 8:30 AM to 10:20 AM Room: CC-4C4
300	* ! Clinical Trials: With So Many Assumptions, How Reliable Are the Results?	Biopharmaceutical Section Government Statistics Section Section for Statistical Programmers and Analysts	Topic Contributed Papers	Tue, 8/11 8:30 AM to 10:20 AM Room: CC-612
324	Emerging Topics in Benefit-Risk Assessment in Clinical Development Decision-Making	Biopharmaceutical Section	Contributed Papers	Tue, 8/11 8:30 AM to 10:20 AM Room: CC-611
325	Multiple Testing Procedures	Biopharmaceutical Section Biometrics Section International Indian Statistical Association	Contributed Papers	Tue, 8/11 8:30 AM to 10:20 AM Room: CC-613
345	* Some Challenges and Advances in Heterogeneous Treatment Effect Evaluation and Trial Design Considerations	Biopharmaceutical Section Biometrics Section	Topic Contributed Papers	Tue, 8/11 10:30 AM to 12:20 PM Room: CC-619
353	SPEED: Topics in Genetics and Biopharmaceutical Applications	Section on Statistics in Genomics and Genetics Biopharmaceutical Section WNAR Biometrics Section	Contributed Speed	Tue, 8/11 10:30 AM to 12:20 PM Room: CC-4C1
368	* ! Longitudinal Analysis	Biopharmaceutical Section Biometrics Section	Contributed Papers	Tue, 8/11 10:30 AM to 12:20 PM Room: CC-616
371	! Power and Sample Size I	Biopharmaceutical Section Survey Research Methods Section	Contributed Papers	Tue, 8/11 10:30 AM to 12:20 PM Room: CC-615
372	Contributed Oral Poster Presentations: Biopharmaceutical Section	Biopharmaceutical Section	Contributed Poster Presentations	Tue, 8/11 10:30 AM to 12:20 PM Room: CC-4B
380	Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee)	Biopharmaceutical Section	Roundtables PM Roundtable Discussion	Tue, 8/11 12:30 PM to 1:50 PM Room: CC- Ballroom 6E
412	* ! Practical Issues with the PFS Endpoint in Cancer Clinical Trial	Biopharmaceutical Section	Topic Contributed Papers	Tue, 8/11 2:00 PM to 3:50 PM Room: CC-610
416	Biopharmaceutical Section Student Paper Award Session	Biopharmaceutical Section	Topic Contributed Papers	Tue, 8/11 2:00 PM to 3:50 PM Room: CC-612
435	Clinical Trial Design III	Biopharmaceutical Section	Contributed Papers	Tue, 8/11 2:00 PM to 3:50 PM Room: CC-613
437	Statistical Issues Specific to Therapeutic Areas III	Biopharmaceutical Section	Contributed Papers	Tue, 8/11 2:00 PM to 3:50 PM Room: CC-614
449	SPEED: Topics in Genetics and Biopharmaceutical Applications, Part 2	Section on Statistics in Genomics and Genetics Biometrics Section Biopharmaceutical Section WNAR	Contributed Poster Presentations	Tue, 8/11 2:00 PM to 2:45 PM Room: CC-4B
212204	Biopharmaceutical Section Business Meeting	Biopharmaceutical Section	Other Cmte/Business	Tue, 8/11 5:30 PM to 7:30 PM Room: S-Cirrus Room
474	* ! DMC Decision-Making: Behind Closed Doors	Biopharmaceutical Section	Invited Panel	Wed, 8/12 8:30 AM to 10:20 AM Room: CC-3B
479	* ! Recent Developments in Adaptive Designed Clinical Development Programs	Biopharmaceutical Section	Topic Contributed Papers	Wed, 8/12 8:30 AM to 10:20 AM Room: CC-3A
505	Clinical Trial Design IV	Biopharmaceutical Section Mental Health Statistics Section	Contributed Papers	Wed, 8/12 8:30 AM to 10:20 AM Room: CC-205
526	* ! New Challenges in Multiplicity Adjustments	Biopharmaceutical Section	Topic Contributed Papers	Wed, 8/12 10:30 AM to 12:20 PM Room: CC-615
546	Adaptive Design III	Biopharmaceutical Section	Contributed Papers	Wed, 8/12 10:30 AM to 12:20 PM Room: CC-616
549	Power and Sample Size II	Biopharmaceutical Section	Contributed Papers	Wed, 8/12 10:30 AM to 12:20 PM Room: CC-617
550	! Multiplicity II	Biopharmaceutical Section	Contributed Papers	Wed, 8/12 10:30 AM to 12:20 PM Room: CC-618
565	Biopharmaceutical Section P.M. Roundtable Discussion (Added Fee)	Biopharmaceutical Section	Roundtables PM Roundtable Discussion	Wed, 8/12 12:30 PM to 1:50 PM Room: CC- Ballroom 6E
592	! Response-Adaptive Randomization: Recent Developments and Controversies	Biopharmaceutical Section International Chinese Statistical Association International Indian Statistical Association	Topic Contributed Papers	Wed, 8/12 2:00 PM to 3:50 PM Room: CC-615
595	* ! Statistical Discrimination and Classification Tools in the Health Care Setting: Challenges and Opportunities for Statisticians, Patients, and Providers	Biopharmaceutical Section Biometrics Section	Topic Contributed Papers	Wed, 8/12 2:00 PM to 3:50 PM Room: CC-614
615	Statistical Issues Specific to Therapeutic Areas IV	Biopharmaceutical Section	Contributed Papers	Wed, 8/12 2:00 PM to 3:50 PM Room: CC-611
616	Trial Monitoring	Biopharmaceutical Section	Contributed Papers	Wed, 8/12 2:00 PM to 3:50 PM Room: CC-605
617	Methods in Clinical Trials 1	Biopharmaceutical Section	Contributed Papers	Wed, 8/12 2:00 PM to 3:50 PM Room: CC-603
635	* ! Advanced Randomization Techniques in Clinical Trials	Biopharmaceutical Section	Topic Contributed Papers	Thu, 8/13 8:30 AM to 10:20 AM Room: CC-606
636	* Concepts and Methods of Interim Adaptation with Conditional Power	Biopharmaceutical Section	Topic Contributed Papers	Thu, 8/13 8:30 AM to 10:20 AM Room: CC-607
639	* ! Challenges in Optimizing Cut-Off Point for Dichotomizing Continuous Variables	Biopharmaceutical Section	Topic Contributed Papers	Thu, 8/13 8:30 AM to 10:20 AM Room: CC-611
657	! Clinical Trial Design V	Biopharmaceutical Section	Contributed Papers	Thu, 8/13 8:30 AM to 10:20 AM Room: CC-603
658	! Statistical Issues Specific to Therapeutic Areas II	Biopharmaceutical Section	Contributed Papers	Thu, 8/13 8:30 AM to 10:20 AM Room: CC-605
659	Methods in Clinical Trials 2	Biopharmaceutical Section	Contributed Papers	Thu, 8/13 8:30 AM to 10:20 AM Room: CC-613
664	* ! Making Better Decisions in Cancer Research: Accelerating Statistical Innovation	Biopharmaceutical Section International Chinese Statistical Association Biometrics Section	Invited Papers	Thu, 8/13 10:30 AM to 12:20 PM Room: CC-608
680	* ! Benefit-Risk Assessment to Support Decision-Making in Drug Development and Regulatory Assessment	Biopharmaceutical Section Committee on Applied Statisticians	Topic Contributed Papers	Thu, 8/13 10:30 AM to 12:20 PM Room: CC-611
699	Missing Data I	Biopharmaceutical Section	Contributed Papers	Thu, 8/13 10:30 AM to 12:20 PM Room: CC-617
700	Topics in Clinical Trials 3	Biopharmaceutical Section	Contributed Papers	Thu, 8/13 10:30 AM to 12:20 PM Room: CC-619
701	Dose Finding, Dose Response in Clinical Trials	Biopharmaceutical Section	Contributed Papers	Thu, 8/13 10:30 AM to 12:20 PM Room: CC-618

For program information, contact the JSM Registration Department or phone (888) 231-3473.

For Professional Development information, contact the Education Department.

The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.

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