ISCTM 2007 Third Annual Congress
Day 1 (February 20, 2007) |
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Related Publications: |
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| AC Leon, H Demirtas, D Hedeker Bias Reduction With an Adjustment for Participants' Intent to Dropout of a Randomized Controlled Clinical Trial  Cliinical Trials. 2007;4(5):540-7.PMID: 17942469 |
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| Session I: Conducting CNS Clinical Trials in the Developing World | Co-chairs: L Alphs JP Lindenmayer |
| Welcome |
G Awad |
| Introduction and Objectives of Meeting | |
| The Challenges and Opportunities for Global Clinical Development - An Industry Perspective | M Page slides  video |
| Multi-National Trials in the Developing World: Conceptualizing the Trials—An Academic Perspective | A Kiev slides video |
| Multi-National Trials in the Developing World: Conceptualizing the Trials—An Industry Perspective | R Anand |
| Setting Up and Implementing Protocols in the Developing World: Special Issues When Conducting Multi-National Trials with Centers in the Developing World and Their Solution--A CRO Perspective | A Kalali |
| Reviewing the Protocol Submissions: A Developing Country Perspective on Issues to Be Considered in Approving a Global Trial-An Indian Regulatory Perspective | S Khanna slides video |
| Conducting CNS Trials in Developing Countries |
JK Trivedi slides video |
| A Case Study: Evaluating Cognition In Multi-National in Developing World Trials | T Sharma R Mohs |
| Reviewing Data from Multi-National Trials in the Developing World: FDA Perspective | NA Khin |
| Reviewing Data from Multi-National Trials in the Developing World: European Regulatory Perspective | G Pons |
| Multi-National Trials in the Developing World: Ethics Roundtable and Discussion | Co-Chairs: G Gharabawi S Khanna slidesParticipants: R Mahmoud A Gilman slides JP Lindenmayer |
| Summary of Session | |
| Dinner with Thorny Topics |
Day 2 (February 21, 2007)
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Session II: Methodological Challenges in Randomized Effectiveness Trials in Psychiatry |
Chairs: |
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DEDICATION TO THE MEMORY OF WAYNE FENTON |
R. Heinssen |
| Introduction: Objectives of Session | |
| Objectives of Effectiveness Trials and Prior Experience with Them in the Psychiatry | P Wang |
| Study Designs (Future Studies) | |
| Statistical Challenges Of Randomized Effectiveness Trials | |
| Results of Randomized Effectiveness Trials: Translation to Clinical Practice | |
| Summary of Session | A Leon |