General Session 1: Update on Critical Path with Special Attention to the Role of Statistical Science
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.
General Session 2: Bayesian Trial Designs - Case Studies
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.
General Session 3: Data Monitoring Committees: Practical Considerations and Useful Strategies
The 2001 FDA Draft Guidance on the Establishment and Operation of Clinical Trial Data Monitoring Committees (DMCs) provides useful insight and guidance regarding the role a DMC may play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.
General Session 4: Pharmacogenomics
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.
General Session 5: Multiplicity Issues in Analysis of Clinical Trial Data
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.
Parallel Session 1 - Post Market Adverse Events: FDA Reporting Systems and
Parallel Session 01Intro, P01_Duggirala_PostMarketSurv, P01_Woo_PostMarketAdverseEvents,
Parallel Session 6: Vaccine Trials
Parallel Session 15: Statistical Issues in Medical Device Trials (Birds-of-a-Feather Session)
2005 Workshop Registrant Directory
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
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC