WHAT: |
For almost a century, the randomized clinical trial (RCT) has been the principal tool driving the development of new and better medical treatments. However, realizing the promise of precision medicine requires a profound shift in our approach to clinical research with improved tools, new conventions for assessment, and a modernized system for approvals that ensures and enhances patient safety and minimizes toxicity. This new approach will move us from the "one drug, one trial" approach commonly used today, to a model that promotes continuous learning and improvement in outcomes. |
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The essential tool of this new approach is the adaptive, platform trial – a continuous, multi-treatment clinical trial model that refines the biological targeting of treatment as it learns. Although there are now a number of such trials underway, the I-SPY 2 TRIAL is one of the first, and now the longest running platform trial. It is also the most successful and the benchmark example of the power and possibilities of this new approach. |
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In this forum, the physicians, scientists, and regulators who are leading the charge in this revolution in clinical care and research, will describe the vision, current progress, and implications in the treatment of disease. Researchers and patients from the groundbreaking I-SPY 2 TRIAL will highlight their progress in improving outcomes for early, high-risk breast cancer and their plans to further positively disrupt the clinical trial space. |
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Following the forum, members of the press are invited to a seminar designed for science writers to provide additional detail and answer questions. |
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WHO: |
Key speakers include: Dr. Laura Esserman, Founder and Co-Principal Investigator of the I-SPY Trials; Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research, FDA; Dr. Anna D Barker, Co-director, Complex Adaptive Systems—Biomedicine, and Director of Transformative Healthcare Networks at Arizona State University; and Dr. Donald A Berry, I-SPY 2 Co-Principal Investigator and lead statistician of Berry Consultants. |
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WHEN: |
Wednesday, September 12, 2018 |
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Press Briefing: 2:00-3:40 pm ET (light lunch at 12:45 pm ET) |
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Science writer seminar: 3:45-5:00 pm ET |
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WHERE: |
The National Press Club | 529 4th St, NW, 13th Floor | Washington, DC |
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RSVP: |
Kristen Zeitzer |
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Director of Marketing and Communications |
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Quantum Leap Healthcare Collaborative |
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(415) 215-6893; [email protected] |
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