ISCTM 2007 Mid-Year Conference
Day 1 (17 September 2007) |
|
| Welcome | G Gharabawi |
| Global Clinical Trials: Opportunities and Challenges | Co-chairs: J Rasmussen L Ereshefsky |
| Summary of Issues Session on Global Clinical Trials Part I | L Ereshefsky slides |
| Overview of Opportunities and Challenges to Global Clinical Trials | J Rasmussen slides |
| EUROPEAN VIEWPOINT | |
| Introduction | C Sampaio slides |
| Regulatory Issues and Concerns on Safety and Efficacy Data Obtained From CNS Global Trials: Focus on Neurology | C Sampaio slides |
| Issues and Concerns on Safety and Efficacy Data Obtained From Global Trials for Anxiety | JP Lepine slides |
| Case Study: Differences in Trial Design/Conduct and Results from Regional Clinical Trials |
R Kahn |
| Issues and Concerns on Safety and Efficacy Data Obtained From Global Trials for Alzheimer’s Disease | R Anand |
| ASIAN VIEWPOINT | |
| Introduction: Role of ICH E-5 Guidelines and New Strategies for Global Drug Development | L Ereshefsky slides |
| Regulatory Issues and Concerns on Safety and Efficacy Data Obtained From CNS Global Trials: View from Japan | Y Uyama slides |
| Update on Clinical Development and Regulatory Approval Issues in China | B P Chan |
| BIOLOGICAL AND POLICY FACTORS THAT MAY INFLUENCE STUDY RESULTS | |
| Setting the Stage: Identified and Theoretical Issues to Consider - Factors that Influence Data Quality | B Edwards slides |
| Metrics Used for Site Selection in Global Clinical Trials | A Kalali |
| Biological Differences Between Regions (Response Polymorphisms) | K-M Lin slides |
| Regional Policy and Procedural Issues that Influence Clinical Trial Results | S Richter slides |
| SUMMARY OF SESSION | R Mahmoud |
| Final Comments | G Gharabawi |
| Dinner Talk: “The 'TeGenero incident' and its effect onCRO approaches to Phase I work” | J Lambert |
Day 2 (18 September 2007) |
|
| WHAT IS CAUSING THE REDUCED DRUG-PLACEBO DIFFERENCE IN OUR RECENT SCHIZOPHRENIA TRIALS AND WHAT CAN WE DO ABOUT IT?” | Co-chairs: N Schooler A Kalali |
| INTRODUCTION | N Schooler A Kalali |
| NATURE OF THE PROBLEM | |
| Historical Perspective on Drug-Placebo Differences: Implications for Future Trial Design | L Alphs slides |
| Reduced Drug Placebo Differences: Evidence from Recent Phase III Trials | S Potkin slides |
| What Have We Learned from Conducting Clinical Trials in Depression? | S. Dube |
| SEARCH FOR THE CAUSES | |
| Identifying the Nature of the Problem: The Use Of PK/PD Modeling to Understand Changes in Drug-Placebo Differences | A VerMeulen slides |
| Possible Causes of Diminishing Drug-Placebo Responsiveness | A Kalali N. Schooler |
| ROUNDTABLE: POTENTIAL SOLUTIONS TO THE DIMINISHING DRUG RESPONSE DILEMMA | |
| Roundtable Discussants | Anand, Ereshefsky, Gharabawi, Leon, Lepine |
| Round 1: Site Profiles | L Ereshefsky |
| Round 2: Patient Profile | R Anand |
| Round 3: Enhanced Assessment Procedures: Implications for Sample Size Requirements | A Leon |
| Round 4: Study Design | G Gharabawi |
| SUMMARY OF SESSION | N Schooler A Kalali |
| Adjourn | G Gharabawi |