Presentations
General Session 1: Update on Critical Path with Special Attention to the Role of Statistical Science
SESSION ABSTRACT
In 2004 FDA announced a new initiative referred to as "a Critical Path Research Initiative" which had as its focus finding additional ways through applied scientific studies to develop better methods and new technologies that may improve the product development process. Since this announcement, statisticians have considered what their contribution to this process might be. This session will focus on the role of statistical science in enhancing more efficient, more effective and safer product development.
G1_Offen_CriticalPath
G1_Simon_CriticalPath
G1_Oneill_Critical
Path
G1_Anello_Critical
Path Intro
General Session 2: Bayesian Trial Designs - Case Studies
SESSION ABSTRACT
Bayesian clinical trial designs offer great opportunity to increase the efficiency of product development and regulatory review. This session will focus discussion on the potential benefits and current challenges in implementing these approaches. Bayesian designs in clinical trials for both drug and medical devices will be illustrated through case studies. Leaders in Bayesian trial design from academia, industry and regulatory agency will present their perspectives and possible solutions to the challenges encountered in implementing Bayesian designs. Regulators will share some practical experiences and the emerging issues that have arisen from these experiences. Statistical considerations, logistical issues, and regulatory agency feedback will be discussed.
G2_Mugglin_Bayesian
G2_Berry_Bayesian
G2_Panel Questions_Bayesian
General Session 3: Data Monitoring Committees: Practical Considerations and Useful Strategies
SESSION ABSTRACT
The 2001 FDA Draft Guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees (DMCs) provides useful insight and guidance regarding the role a DMC may play in a drug development program. Several practical issues, though, are likely to surface when implementing a DMC. This session will provide insight into the issues facing pharmaceutical companies and the FDA when a clinical trial involves a DMC -- issues such as the use of internal versus external DMCs, partial versus complete unblinding, information sharing across DMCs, and the advantages and disadvantages of having an independent statistician perform the interim analysis. Critical issues surrounding the statistical assessment of safety endpoints will also be examined. Strategies, both prospective and retrospective, to enhance safety signal detection in randomized clinical trials will be discussed.
G3_Omeara_DMCs
G3_Snapinn_DMCs
G3_Schwab_DMCIntro
G3_Wittes_DMC2
General Session 4: Pharmacogenomics
SESSION ABSTRACT
Technical and other issues abound when incorporating molecular and/or genomic biomarkers in clinical drug development. This is especially true in disease areas where the molecular pathways are not well established or when the mechanism of action of the pharmacologic effect is not well understood. These issues are also thorny in disease areas where the typical drug development program may involve the use of underpowered Phase II's, which is precisely that point in drug development when the exploration of candidate biomarkers would be most useful. This session will discuss these issues from both statistical and drug development strategy perspectives.
G4_Cabrera_Pharmacogenomics
G4_Ostland_ Pharmacogenomics
G4_Penello_Pharmacogenomics
G4_Wang_Pharmacogenomics
G4_Bajamonde_Pharmacogenomics
General Session 5: Multiplicity Issues in Analysis of Clinical Trial Data
SESSION ABSTRACT
The session will cover important topics that arise in the analysis of clinical trials with multiple endpoints, including the generalized Familywise Error Rate (gFWER) concept and branching testing strategies such as gate-keeping. Prof. Hsu of Ohio State, Dr. Huque of FDA and Dr. Alex Dmitrienko of Eli Lilly and Co. will give their views on various issues and possible resolutions to these issues from the perspective of academia, FDA and industry, respectively.
G5_Dmitrienko_Multiplicity
G5_Huque_Multiplicity
G5_Hsu_FDA_industry
Parallel Session 1 - Post Market Adverse Events: FDA Reporting Systems and
Surveillance
Parallel Session 01Intro,
P01_Duggirala_PostMarketSurv,
P01_Woo_PostMarketAdverseEvents,
P01_Levine_
PostMarketAdverseEvents
Parallel Session 2: Development and Use of Patient-centered Questionnaires
in Clinical Research
P02_Kammerman_PatQuestionnaires,
P02_Sloan_PatQuestionnaires,
P02_Rodenberg_PatQuest
Parallel Session 3: Bridging Studies - Concept, Issues, and Their Applications
in International Simultaneous Drug Development
P3_Chow_Bridging,
P03_Takeuchi_Bridging
Parallel Session 4: Statistics in Preclinical Studies
P04_Menton_PreClinical,
P04_Moon_Preclinical,
P04_Crimin_PreClinical
Parallel Session 5: Topics in Drug Safety
P05_Bull_TopicsDrugSafety,
P05_ Dong _TopicsDrugSafety,
P05_Kulldorff_DrugSafety
Parallel Session 6: Vaccine Trials
ParallelSession06PanelDisc.ppt
Parallel Session 7: CDISC Initiatives: Impact on Electronic Data Submission
P07_Christiansen_CDISC,
P07_Nessly_CDISC,
P07_Wilson&Liu_CDISC
Parallel Session 8: Non-inferiority Studies
P08_Tsong_Noninferiority,
P08_Dagostino_Noninferiority
Parallel Session 9: Contemporary Challenges in Statistical Evaluation of
Diagnostic Products
P09_ Baker_
DiagnosticProducts,
P09_ Kondratovich_
DiagnosticProducts,
P09_ShiDiagnosticProducts
Parallel Session 10: Integrated Statistical Computing Environments for Efficiency
and Quality
P10_Schumack_Integrated
Comp,
P10_Hopkins_IntegratedComp,
P10_Wilson_Integrated
StatComputing
Parallel Session 11: Flexible Design - Are We Ready Yet?
P11_Posch_FlexibleDesigns,
P11_ Dragalin _FlexibleDesign,
P11_ Hung _FlexibleDesign,
P11_ Krams _FlexibleDesign
Parallel Session 12: Statistical Methods for Nonrandomized Trials and Subverted
Randomized Trials
P12_Berger_NonRandomized,
P12_White_NonRandomizedStudies,
P12_Yue_NonRandomizedStudies
Parallel Session 13: Combination Products
P13_JHung_CombProducts,
P13_Peterson_CombProducts,
P13_ChanAhnn_CombProducts
Parallel Session 15: Statistical Issues in Medical Device Trials (Birds-of-a-Feather
Session)
FDA-Ind_med_devtitle_05.ppt,
drugsvsdevices1.ppt,
Devicevsdrug2.ppt,
CerkvenikNRStudies1.ppt,
FDA-Indmeddev05.ppt,
FutureDESChallengesSept162005.ppt
Parallel Session 16
P16_Sethurman_QT,
P16_Zhang_QT
2005 Workshop Registrant Directory
2005RegistrantList.rtf
Key Dates
-
April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC