Thursday, March 26, 2009

Workshop Title/Theme Naming Competition

Sessions have been identified for the 2009 FDA/Industry Statistics Workshop and included in a previous blog post. The three selected plenary sessions are:

1) Future directions in planning safety analysis and risk management
2) Regulatory Issues in Global Harmonization of Clinical Studies
3) World is (almost) Flat: Statistical Considerations as Clinical Development goes Global

Based on this we are ready to open up the Workshop Name/Theme competition!

Previous Session names have included:
2007 - Translating Innovation into Practice through Effective Partnerships
2006 - Statistics in the FDA and Industry: Past, Present, and Future
2005 - Safety and the Critical Path: Keys to Successful Development of Medical Products
2004 - Science, Statistics and Decisions: The Right Questions, The Best Answers
2003 - Statistics: From Theory to Regulatory Acceptance
2002 - The Information Revolution - Who's Mining the Store?
2000 - Statistically Sound Decision Making
1999 - Statistical Issues in the New Millennium
1998 - Current Statistical Issues, Drugs, Biologicals, Medical Devices, Risk Assessment
1997 - Working Together to Expedite the Development of New Pharmaceutical Products
1996 - Analysis and Collection of Adverse Event Data

The competition for naming this year's workshop will occur here, on the FDA/Industry workshop blog.

To be considered for this competition, please leave a "comment" on the blog with your proposed WORKSHOP TITLE/THEME as well as your NAME (and hopefully your contact information or at least your professional affiliation so we can give you credit and your prize at the workshop in September:-).

This competition will be open until April 15th. Please note: in cases of multiplicity issues (i.e., identical suggestions from multiple individuals), the first person who proposes the name/theme/ title within the comment section of this blog post.

Good Luck!

Tammy and Carmen

Wednesday, March 25, 2009

Announcement: Sessions Selected for Inclusion in the 2009 FDA/Industry Statistics Workshop

The following sessions* (presented in no particular order) have been selected for inclusion in the 2009 FDA/Industry Statistics Workshop. Session organizers please see blog post on "Timeline for Session Organizers"

Plenary Sessions (90 minutes):
1. Future Directions in Planning Safety Analysis and Risk Management
2. Regulatory Issues in Global Harmonization of Clinical Studies
3. The World is (almost) Flat: Statistical Considerations as Clinical Development goes Global

Concurrent Sessions (75 minutes):
1. PK/PD Model-based Drug Development
2. Adaptive Design – Theory and Methods
3. Adaptive Design: Applications and Examples
4. Longitudinal Analysis, Missing Data and Assessment of Durability of Treatment Effect
5. Effective Use of Interim/Futility Analysis: A Case Study and Regulatory Considerations
6. Evaluation of Efficacy and Safety in the Presence of Subgroup Heterogeneity
7. Survival Analysis-Issues related to Follow-up in Time to Event Endpoints
8. Bayesian Methods throughout the Lifecycle of Medical Products
9. Multiplicity Adjustment in Clinical Trials with Multiple (Primary and Secondary) Endpoints: Issues and Concerns
10. Meta Analysis with a Focus on Safety
11. Design and Analysis for Non-InferiorityTrials – A Practical Perspective
12. Biomarkers in Drug-diagnositic Co-development
13. Endpoint Issues in Oncology
14. Recent Issues in CNS Drug Development
15. Views on Integrated Summary of Effectiveness and Integrated Summary of Safety: From FDA and Industry Perspective
16. Effective Communication and Collaboration between FDA and Industry Statisticians in the Regulatory environment
17. Quantitative Approaches to Decision Making in Clinical Development
18. Design Issues in Clinical Trials: From Randomization to Assay Sensitivity
19. Food Safety and Validation method
20. Veterinary Medicine I – Design and Analysis
21. Veterinary Medicine II – Issues in Target Animal Safety Studies
22. Medical Devices- Aspects of missing data unique to medical device trials
23. Post-Approval Issues for Diagnostic Devices
24. Statistical Issues in Vaccine Clinical Trials

Special Interest Forum : Avoiding Type III Errors in CMC Statistical Methods

* Program is preliminary and subjected to change

Timeline for session organizers

April 15thSpeakers confirmed. (Note: Session organizers must ensure speakers know that they will be responsible for paying for ALL conference EXPENSES including: registration, hotel, travel)

Session Organizer primary contact to provide a single email to with order of presentation, the timing (length of presentation), speakers’ complete contact information (e-mail, phone and professional affiliation) .

April 17thDeadline for submission of proposals for Roundtable Luncheon Discussion to

May 11th — Speakers provide 100-200 word (5-10 Sentence, 1 paragraph) abstract related to their specific topic to session organizers

May 11thFinalized Abstract due to (This is the updated version of the abstract submitted on Feb 27). Session Organizer primary contact to provide a single finalized comprehensive session abstract consisting of
· Finalized Title of the session
· Names of all organizers
· Brief session description (~1 paragraph to be included in workshop brochure),
· For each presentation, please include title, abstract (5-10 sentences, 1 paragraph), length of presentation, Speakers’ contact info into the abstract

June 1st — Workshop Registration Opens

Early June
— Telecon between Session organizer/chairs and All Session Speakers. Telecon organized by session organizers with all speakers/discussants for introductions and to reduce any presentation overlap.

August 10th — Speakers provide draft presentations to session organizers

August 14th — Deadline for REGISTRATION of speakers, session organizers, short course instructors, roundtable luncheon discussants

August 18thSpeakers provide finalized presentation and Brief Biographical Sketch (for introductions during the workshop) to session organizer/chair

August 20thSession Organizer primary contact to provide a single email attaching all speakers finalized presentation to

Late Aug/Early Sept — Telecon between Session organizer/chairs and All Speakers in session.
The final teleconference with session speakers, organizing committee/session chairs will provide last minute updates about conference and ensure all tasks are delegated and timing is understood.

Sept 23-25th — Short Course/Workshop from 8 a.m. -5 p.m. Capitol Hilton

Accepting Roundtable Luncheon Discussion Proposals

We hope you are planning to attend the FDA/Industry Statistics Workshop September 23-25th, 2009 at the Capitol Hilton in Washington DC.

To ensure the FDA/Industry Statistics Workshop is lively, productive and useful to all attendees, there will be roundtable luncheon discussions on both days of the workshop that have plenary/concurrent sessions (Thursday and Friday September 24-25th).

In a change from other years, it is envisioned the roundtable luncheons will be intimate discussions led by many volunteers. Thus, we are currently seeking interested volunteers.

The deadline for submission of Roundtable Discussion proposals for the 2009 FDA/Industry Statistics Workshop is April 17th. (Please note for those of you who might be like to be paired with a co-discussant an early response deadline of April 5 is needed for participants who wish to be matched with co-leaders from FDA or Industry).

If you have already submitted a proposal to be a roundtable discussion leader, THANK YOU.

If not, we invite you to participate as a roundtable luncheon discussion leader in 2009. This year we are attempting to pair an industry and a FDA statistician as co-leaders at the same table; however both co-leaders can be from industry, or both from FDA, if that is your preference. This year the participants will receive a box lunch and then join a round table group at the mid-day break during both days of the workshop.

Tables of 6-8 persons will be located in zones with similar discussion topics spread out over 7-12 different rooms. Our hope is to have a wide variety of discussion topics led by many different people.

Are you ready to consider this volunteer opportunity?

The Round Table Discussion Table proposal should utilize the following template when sending an e-mail to the roundtable luncheon discussion core committee (Diane Sweeney and Anna Nevius). In this e-mail please include information about the proposal:

EXAMPLE e-mail, expressing interest in volunteering/proposing a Roundtable Luncheon Discussion.

To: FDAIndustry2009Lunch (at) (NOTE: use @ symbol when creating e-mail)
CC: Yourself (always a smart idea!)
Subject: Roundtable Discussion Proposal: Your NAME, Proposed TOPIC/TITLE

Indicate Day or Day(s) preferred.
Thursday ( ) and/or Friday ( )

Roundtable Luncheon Discussion Proposal
Discussant Leader Name:
Professional Affiliation:

As you think about volunteering we have the following suggestions for leading an effective discussion--think about 5 questions (and your responses) to jump start or lead the discussion. You do not need to be a well known leader in the field; the idea is to generate exchange of ideas, discussion and to network. In fact we suggest that you allow at least half of the lunch break for networking.

For those of you hesitant to commit to leading a roundtable luncheon discussion solo, we will also endeavor to connect you with other discussion leaders with similar topics in the same zones in the weeks prior to the workshop or even pair you with person with a similar topic (if you respond by April 5th).

Each session included in the conference has contributed two round table discussion leaders, but many more are needed. Thus of course please feel free to distribute this blogpost to other colleagues who may be interested in taking on this rewarding role as a Roundtable Luncheon Discussant Leader.