September 14, 2022
Open to all ISPOR Members and Non-members
Title: Clinical Outcome Assessments in the Asia Pacific Region: Strategy & Implementation
10:00PM EDT | 2:00AM UTC | 4:00AM CEST
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Description
Asia Pacific regional markets, including but not limited to mainland China, Japan, South Korea and Taiwan, play increasingly important roles in global clinical development. Patient-centric endpoints via clinical outcome assessments (COAs) and electronic COAs (eCOAs), are getting more and more attention in clinical research design and execution.
The purpose of this webinar is to raise awareness in COA strategic planning, reflect applicable research considerations, and present good practices in translation and cultural validation for clinical studies conducted in the Asia Pacific region.
The discussion will balance the assessment of current standards and the envisioning of future fit.
Learning Objectives
• Strategy: Understand the full values of clinical development in the Asia Pacific region, relate to the expectations of key stakeholders, identify factors that may result in sub-optimal clinical research, and recommend holistic global COA strategy as early as possible.
• Research: Review qualitative and quantitative considerations to mitigate research risks and enhance scientific rigor when validating new or existing COAs in the Asia Pacific region, e.g., content validity assessment, and needed quantitative considerations.
• Execution: Introduce the impact of cultural adaptation/linguistic validation of COAs, elaborate practical considerations/industry standard processes that may help expedite clinical development in the Asia Pacific region, and address challenges/gaps that are often encountered.
Presenters:
Donald M. Bushnell, MA, Senior Research Scientist, Evidera, Bethesda, Maryland, USA
Nan Luo, PhD, Associate Professor, Saw Swee Hock School of Public Health, National University of Singapore, Singapore
Yaozhu Juliette Chen, MPA, Director, Takeda Development Center of Americas, Cambridge, MA, USA
Angie Lee, BA, Manager, Linguistic Solutions, QualityMetric, Johnston, Rhode Island, USA
Please note: On the day of the scheduled webinar, the first 1000 registered participants will be accepted into the webinar. For those who are unable to attend, or would like to review the webinar at a later date, the
full-length webinar recording will be made available at the ISPOR Educational Webinar Series webpage approximately 2 days after the scheduled webinar.