Speakers:
GlaxoSmithKline • Wyeth Research
Berry Consultants • FDA • Merck
CONFERENCE FEATURES
- In depth case studies
- Expert’s critique of case studies
- Problem solving break-out sessions
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Click here to view the following webcast:
Adaptive Clinical Trials Webcast
Guest: Jerald S. Schindler, Dr. P.H., Vice President, Biostatistics and Research Decision Sciences, Late Stage Clinical Development Statistics, Merck Research Laboratories
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Who Should Attend:
If you want to learn how to implement adaptive trial designs at your company and have responsibility in any of the following areas, this is a must attend event for you!
- Biostatistics
- Clinical/Medical Research
- Clinical Operations
- Clinical Supplies
- Contract Research Organizations
- Data Management
- Medical Affairs
- Patient Recruitment
- Project Management
- Regulatory Affairs
Quote from
2007 Attendee
“This conference opened my eyes to the momentum behind adaptive trial designs.”
- Dr. Patricia R., Vice President Inflammation, Clinical Development, Celgene Corporation
Scope of conference – Adaptive trial designs are improving the efficiency of drug development by saving time and money to run clinical trials as well as providing more information to select the right dose(s) for phase III confirmatory trials. In addition, regulatory authorities have communicated their willingness to consider and discuss the use of adaptive designs in clinical trials. Despite this, there are several issues which are preventing the wide spread implementation of adaptive designs; 1) technology, 2) information, and 3) experience.
Format and content - Rather than a series of 30 minute presentations, this conference is quite different. It will provide 3 to 4 in depth case studies in which Clinical researchers paired with technology and/or statistical professionals who are currently engaged in the planning and implementation of adaptive trials will provide detailed case studies from start to finish. These case studies will review:
- Drug being developed and indication being pursued
- Process for effectively engaging the clinical trial study team
- Protocol design, endpoints, planned analysis and modifications
- Technology used to support randomization and drug supply
- Technology used to support real time collection and reporting of adaptive endpoints
- Patient recruitment plan
- Comparison scenario analysis
- Technology used to run simulations reports and their analysis
- Results of trial
- Lessons learned
In addition, 1-hour problem-solving breakout sessions which will allow meeting participants to speak directly with experts in the field will be provided.
Desired Outcome – Attendees will have information regarding the technology needed and issues that arise during the planning and implementation of adaptive clinical trials and how to solve them in the area of:
- Protocol development
- Statistical analysis
- Real time data management
- Adaptive randomization and drug supply
- Clinical operations
Scientific Advisors
Michael Krams, M.D., Assistant Vice President, Adapative Trials, Clinical Development Wyeth
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Judith A. Quinlan, Ph.D., Vice President, Adaptive Designs, Cytel
Jerald S. Schindler, Dr.P.H., Vice President, Biostatistics and Research Decision Sciences, Late Stage Clinical Development Statistics, Merck Research Laboratories