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Shaking the Toolbox: Evolutions in Approaches in Trial Design
Session Chair(s)
Robert Hemmings, MSc
Partner
Critical Path Institute, United States
The randomised controlled trial (RCT) is alive and kicking for good reason, but conventional design and analysis alone will not serve the future of drug development, licensing and reimbursement. Targeted medicines, orphan conditions and life cycle management call for us to consider other approaches whilst retaining robust methodology. A series of clinical trial designs will be presented and discussed; even the well-established RCT can be improved.
Speaker(s)
Selecting and Implementing the Right Dose
Frank Bretz, PhD
Novartis , Switzerland
Distinguished Quantitative Research Scientist
Ensuring Alignment on What Treatment Effects Are of Interest to be Estimated in Clinical Trials: New ICH Guidance
Christine Fletcher, MSc
GlaxoSmithKline, United Kingdom
VP/Head, Speciality and Primary Care Statistics
Issues in Designing and Implementing a Clinical Trial in a Healthcare Database: Experiences from the Salford Lung Study
Lucy J Frith, MBA, MSc
Glaxosmithkline, United Kingdom
Director, Clinical Statistics, Respiratory
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