Since publication of ISPOR guidance in 2005 (Wild et al), the standard process for the linguistic validation of Clinical Outcomes Assessments (COAs) has become widely known and accepted. However, the ISPOR guidance is now 10 years old and it was developed only for patient reported outcomes (PROs) as opposed to clinical reported outcomes (CLINROs) and performance based measures. In addition it did not include any reference to ePROs. This webinar will review the ISPOR guidance in relation to changes over the past 10 years in the COA environment and describe some of the current issues, methodological challenges and solutions in this ever changing field.
- Discover what Linguistic Validation is and why it is important
- Review ISPOR guidance in relation to developments in (e)COA landscape over the last decade
- Focus on methodological challenges presented by different types of (e)COAs, audiences and platforms
- Discuss potential next steps in finding solutions to these challenges
Helen Anderson, DPhil, Manager, ICON Language Services
Helen joined ICON Language Services in August 2010, and has experienced all stages of the translation and linguistic validation process, having spent three years in project management before transitioning into a client management role in 2013. Based in the Oxford office, she leads a client management team and has a special research focus in linguistic validation methods. Helen completed her DPhil in Italian Literature at St Anne’s College, Oxford University and holds a Master of Studies in European Literature (Oxford) and a BA in French & Italian (Bristol). She previously worked as Italian teaching fellow at Oxford University and as a translator of academic publications and fiction.
Diane Wild, MSc, Consultant
Diane has over twenty years of experience in health research, sixteen years of which have been spent in patient reported outcome (PRO) research. She is the founder of Oxford Outcomes Ltd (acquired by ICON in 2011) and former Vice President ePRO and Translations at ICON plc. Diane has worked on and managed a large number of UK-focused and international projects, and has particular expertise and interest in cross-cultural PRO research and in methods relating to linguistic validation. She has an MSc in Health (1992) and prior to setting up Oxford Outcomes, was as a researcher in the NHS and at the University of Washington.
Who Should Attend?
Senior level professionals at biopharmaceutical companies working in:
- Regulatory Affairs
- Late Phase Research
- Project Management
- Patient Registries
- Risk Management
- Market Access
ICON’s Commercialisation & Outcomes practices provide insights to clients on strategies and execution for long-term value through customised engagements that fit the compound, the company and the market, maximising products’ success and their benefits to patients’ health.