戻る Agenda
Study Design and Innovative Statistics
Session Chair(s)
Robert Hemmings, MSC
Critical Path Institute, Netherlands
Having “got the questions right” (Session 0403 Change is Coming… Getting the Questions Right in Clinical Development), trial designs and analytical approaches are needed that are able to give reliable answers to those questions while being efficient in terms of costs and burdens to patients and the healthcare system. This session will explore novel approaches that are working in practice.
Learning Objective : The participants will be able: • To understand the range of innovative clinical trial design strategies and how these can be incorporated into drug development and evidence generation plans • To share case studies and potential challenges that need to be overcome to implement more complex trial designs • To discuss questions and concerns different stakeholders such as regulators, HTAs/Payers
Speaker(s)
Innovation in Clinical Trial Design – Why Embracing Novel Approaches is Important and Where We Go from Here
Christine Fletcher, MSC
GlaxoSmithKline, United Kingdom
VP/Head, Speciality and Primary Care Statistics
New Precision R&D Models in Oncology – Complex Clinical Trials to Investigate Histology-Independent Indications
Sacha Wissink, PHD
MSD Netherlands, Netherlands
Executive Director, Regulatory Affairs Europe
Adaptive Trial Designs: Delivering the Unicorn of Clinical Trials in the UK
Matt Cooper, PHD
NIHR Clinical Research Network, United Kingdom
Business Development and Marketing Director
Panel Discussion
Kirsty Wydenbach, DrMed, MSC
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Expert Medical Assessor