Monday, January 26, 2009

Sessions to be discussed on Jan 30

With the help of the steering committee, we have reduced the redundancy in the list of sessions suggested. The following 41 candidate sessions will be discussed at the Organizational meeting on Jan 30. Of the 41 sessions listed below, approximately 30 sessions will be selected based on a vote at the meeting.

A Pre-clinical/Tox
1 PK-PD Analysis
2 Toxicology

B Adaptive Designs
3 Adaptive Design - Theory and Methods
4 Adaptive Design - Applications and Examples
5 Adaptive Design - Other Issues (interactions between FDA/Industry)

C Safety
6 Future directions in planning safety analysis and risk management
7 Quantitative risk/benefit assessment
8 DMC and Safety Monitoring
9Thorough QTc study design and analysis

D Global Trials
10 Regulatory Issues in Global Harmonization
11 Statistical Issues in Global Harmonization

E Phase I Trials
12 Statistical and Design Issues in Phase I trial (cross over, blinding)

F Statistical Issues in Clinical Trials
13 Design Issues in Clinical Trials: Placebo/Historical Control/ Randomization
14 Interim Analysis/Futility analysis
15 Subgroup Analysis/Heterogeneity /Adjusting for Covariate
16 Survival Analysis
17 Statistical Modeling/ Simulation for Decision making

G Longitudinal Data Analysis and Missing Data
18 Longitudinal Analysis, Missing Data and Durability

H Bayesian
19 Bayesian Analysis and Designs

I Multiplicities/Multiple Comparison
20 Multiplicities/Multiple Comparison

J Meta Analysis
21 Meta Analysis

K Non-inferiority Trials
22 Non-Inferiority Trials - Designs and Issues

L Quality of Clinical Program
23 Quality of Clinical Programs- Designs/Methodological/Robustness

M Genomics/Biomarkers
24 Biomarker Evaluation
25 Genomics

N Technical/Computations/Graphics
26 Open-source software/global platform

O Therapeutic Area Specific Issues
27 Oncology I - Issues
28 Oncology II. - Designs and Analysis
29 Psychiatric Clinical Trials/ CNS/Insomnia

P Regulatory Issues
30 ICH-E9/ISS/ISE Analysis plans
31 Communication between FDA/Industry statisticians

Q Career Development
32 Statistical Consulting

R Patients Reported Outcome
33 Patients Reported Outcome

S Chemistry, Manufacturing and Control (CMC)
34 CMC I

T Food Safety
36 Food

U Veterinarian Medicine
37 Veterinary Medicines I - Design and Analysis
38 Veterinary Medicines II - Issues

V Devices
39 Devices I - Medical
40 Devices II - Diagnostics

W Vaccines
41 Vaccines

No comments: