Jan 15 - Deadline for submission of courses/sessions

Thank you for your interesting suggestions for courses and sessions. We have received over 100 session and 20 course ideas!

The lists of suggested sessions and courses are posted below. If you have made a suggestion but do not see it posted, please drop Tammy/Carmen a note at FDAIndustry2009@gmail.com. In the coming weeks, to prepare for the January 30th organization meeting, we will be consulting with our steering committee to better organize the ideas.

Please come back and check often for updates.

Also, a quick reminder that all conference correspondences should be directed to our conference e-address: FDAIndustry2009@gmail.com, instead of our work emails. Tammy and I have both been put in e-jail for the volume of emails we've received. This will also ensure that your emails reach us safely.

Submitted Session Proposals (as of Jan 15th)

A. Pre-clinical/Tox

1. Individualized medicines? Role of PK-PD analysis
2. Overview of Toxicology (Preclinical)
3. Using PK-PD modeling to support selection of First-In-Human dose

B. Adaptive Designs

1. Adaptive Designs - Implementing a Bayesian Outcome
2. Recent Development in Adaptive Design
3. Bayesian Adaptive Designs
4. Unconditional use of Conditional Power
5. Adaptive Group Sequential Designs
6. Adaptive Design in practice - Successful implemetationof early/late stage AD
7. Case Studies in Adaptive Design
8. Adaptive Dose Ranging Studies
9. Non-proportional Hazards, Adaptive Design, Group-Sequential Design
   

C. Analysis of Safety Data

1. Safety Analysis and the Role of DSMB
2. Analysis Approaches for Pre-marketing Safety Data
3. FDA ISS Guidelines And SPERT Initiatives on Safety Analysis
4. Benefit/Risk, Motivation of Methods
5. Rare events monitoring
6. Large Simple Trial for safety evaluation
7. Risk-benefits
8. Safety, PSAP and Risk Management
9. Risk Management Plan: Risk Analysis and Management.
10. Causal Analysis of Safety Data
    

D. Global Trials

1. Global Harmonization
2. Multi-Regional Clinical Trials
3. Changing Landscapes - Statistical Issues in Global Clinical Development
4. Post Marketing Research, Global Perspective

E. Phase I Trials

1. Statistical challenges in Ph I Drug Development
2. Phase 1 trials: Blinded or Unblinded at the Sponsor Level?

F. Statistical Issues in Clinical Trials

1. Cross-Over Design with time-to-event endpoint
2. Placebo Response and Mitigation Strategies in Clinical Trials
3. Role of statistical modeling in early decision makings of drug development
4. Statistical Issues in Identifying Early on-Tx Measures of Efficacy
5. Statistical Issues in assessing Durability of Effects
6. Forced Randomization in Clinical Trials
7. Extracting information from blinded trials
8. Futility Analysis
9. Interim Analysis
10. Subgroup Heterogeneity in Drug Effects
11. Post Randomization Adjustment of Covariates
12. Non-parametric Resampling techniques in Clinical Trials
13. Statistical (Robustness) assessment of clinical development programs
14. Analysis of Covariance in RCT
15. Experience with Flexible Bayesian Plan in Phase II Biologic

G. Longitudinal Data/Analysis and Missing Data

1. Longitudinal Analysis in dealing with missing values
2. Missing Data/Multiple Imputation
3. Sensitivity analysis for longitudinal studies with withdrawals in practice
4. Joint Modeling of Longitudinal and Event Time Data
5. Approaches in dealing with missing data
   

H. Bayesian

1. Bayesian Methodologies
2. Bayesian Interim Analysis
3. Type I Error Rate Related Issues for Bayesian Trial Design in a Regulatory Environment

I. Multiplicities/Multiple Comparison

1. Multiplicity in assessing multiple studies
2. Multiple Comparisons
3. Multiple Endpoints
4. False Discovery Rates

J. Meta Analysis

1. Analysis of subgroups across studies, in the meta-analytic framework
2. Comparative effectiveness via indirect comparisons/historical control

K. Non-inferiority Trials

1. Issues in Non-inferiority Trials, margins, population, historical control

L. Quality of Clinical Trials

1. Methodological quality of clinical trials
2. Assuring Data Quality in Clinical Trials

M. Vaccines

1. Vaccines - Multiple Comparisons and Analysis in Vaccines Trials
2. Sensitivity analysis for missing data in vaccine trials

N. Genomics/Biomarkers

1. Prospective Calculation of Gene Identification power in analysis controlling the false discovery rate
2. Analysis of Large Biomarker Data sets
   
3. Defiing Performance Characteristics of Clinical Biomarker Assays
   > Variance Function based statistical method for optimal quality assessment for RT-QPCR replicate well performance
   > statistical metrics to quantify relative bias due to Rt-qPCR assay
4. Integrating Evidence for Selecting Diagnostic Biomarkers for Drug Dev
5. Enabling biomarker integration in the drug development
6. Assessing Clinical Utility of Biomarkers developed by consortia/institutions in Genetics/Genomics
7. Prospective calculation of gene identification power in analyzes controlling the false discovery rate
8. Weibull Failure Time Mixture Models for evaluating Efficacy in the Presence of Biomarker
9. Statistical Issues for Micro-array classifiers.

O. Technical/Computations/Graphics

1. Use of Open-source software for regulated clinical Trial research
2. Global platform for global clinical trials
3. Strategies for Statistical Software Development for Drug and Diagnostics Research

P. Therapeutic Area Specific Issues

1. Specific Issues in Oncology Trials
2. CNS Issue - Diary Data
3. CNS Risk - suicidal ideation
4. Cost Effective Go/No Go Decision in Oncology
5. Endpoint Issues in Oncology Clinical Trials
6. Censoring Issues in Survival Analysis
7. Adequacy of patient follow-up and sensitivity analyses in the presence ofmissing data for PFS in oncology trials
8. Statistical Issues in Design and Analysis of Psychiatric Clinical Trials

Q. Regulatory Issues

1. Changing Political landscape in Drug Development - Discussions of Avandia and other blockbuster drugs that came under dark clouds
2. ICH-E9 Update - what works and what doesn't
3. Communicating to FDA statisticians unambiguously using CDISC ADaM
4. Issues regarding generation of a SAP for ISE/ISS
5. Unifying Data in FDA and its use in drug review
   

R. Career Development

1. Effective communication with clinicians
2. Statistical Consulting
3. Working Session on Improving communications between project statisticians and FDA statistical reviewers
4. A statistical Career - beyond power calculation and p-values

S. Patient Reported Outcome

1. PROMIS, the NIH Roadmap for a Patient Reported Outcomes Measurement Information System.
2. Patient Reported Outcomes
3. Determining validity of patient reported outcomes (PROs) as endpoints in clinical research settings
4. A review of the impact of the draft PRO Guidance document on the statistical analysis of PRO data.
   

T. QTc Study

1. Thorough QTc study design and analysis
2. Statistical Issues in Thorough QTc study

U. Chemistry, Manufacturing and Control (CMC)

1. ICH-Q8 Design Space: Statistical Strategies and Case Studies
2. Issues in Chemistry, Manufacturing, and Control (CMC)
3. Increasing Objectivity in Risk-based Approach for Biopharmaceutical Development, Manufacturing, and Control
4. The role of multivariate projection methods in Quality by Design
   

V. Food Safety

1. Food Safety-Collection and analysis of safety data of food borne pathogens

W. Veterinarian Medicine

1. Important Statistical Concepts in the Planning, Analysis and Monitoring of Veterinary Clinical Trials
2. Assay Validation in Veterinary Biologics and Pharmaceuticals
3. Monitoring Assay Stability in Veterinary Biologics and Pharmaceuticals
4. Measuring the Effect of Intervention in Veterinary Biologics and Pharmaceuticals
5. Study Design Issues in Veterinary Biologics and Pharmaceuticals

X. Devices

1. Drug Device Co-Development Considerations
2. Approaches and Problems with Allergy Device Perfromance Validation
3. Regulatory and Statistical Issues for Companion Diagnostics in Drug-Device combination products

January 30th Organizational Meeting

The January 30th Organizational Meeting will be held at the Universities at Shady Grove Conference Center from 8 a.m. - 4 p.m.

The Universities at Shady Grove is located off Shady Grove Road in Rockville, MD. There are several hotels located near the Washington Rio which is within 1 mile of this meeting location.

If you are driving, the Shady Grove University (and Washington Rio Hotels) is conveniently located off the major Interstate (I-370). If you are using the train, the meeting location is about a 10 minute taxi-ride from the Metro.

More details will follow including an Agenda.

If you would like to RSVP to attend this meeting please contact Carmen/Tammy at
FDAIndustry2009@gmail.com. *** Please also indicate whether you'd like chicken or vegetarian lunch. ***

Proposed Short Courses (to date as of Jan. 15)

1. Adaptive Designs
2. Data Safety Monitoring Committee's
3. Working Discussions on Statistical Consulting (interactive small course for <30> pariticpants)
4. Statistical Graphics
5. Roles and Strategies for Covariate Adjustment in RCTs
6. Introduction to Clinical trials (FULL DAY appropriate for statisticians with 5 years experience)
7. Examination of Risk/Benefits
8. Missing Data Analysis
9. Dose Finding
10. Longitudinal Analysis
11. Survival Analysis
12. Safety Analysis
13. Bayesian Analysis
14. Meta Analysis
15. Likelihood Methods in RCT
16. Resampling Techniques in Medical Research
17. Biomarkers (selecting, identifying, assay issues)
18. Assessing and Improving Trial Quality
19. Interim Analyses and unblinding
20. Non-proportional Hazards, Adaptive Design, Group-Sequential Design

Happy New Year and Brief Update on Workshop details!

Happy New Year!

Carmen and I are excited about the upcoming FDA/Industry Workshop we are co-chairing in Fall 2009.

The conference location/hotel has been arranged: the Capitol Hilton right next to the White House.

The conference date has also now been confirmed: Wed.-Fri. Sept. 23-25th.

We look forward to a productive organizational meeting on January 30, 2009 at the Shady Grove University. If you are interested in participating please contact us at:
FDAIndustry2009@gmail.com

We wish you a Safe and Happy New Year and look forward to seeing you in Sept 2009 or perhaps at the organizational meeting in late January!

Solicitation for Chairs, Idea's, Topics, Sessions, Courses and Speakers

Welcome to the FDA Industry Blog: Our mechanism for Clear Communication!

Good Afternoon!

Welcome to the FDA/Industry Statistics Workshop Blog for 2009! We hope you will consider contributing to this very exciting conference to be held in the DC area in Fall 2009!

As information becomes available about the specific time and location we will post this information. Additionally in the near future we will provide a timeline on the right hand side of this Blog to keep you posted about upcoming events and deadlines.

We are looking forward to an great year that will culminate with a successful FDA/Industry Statistics Workshop in Fall 2009!

Tammy Massie (FDA) and Carmen Mak (Industry)