The administration of patient reported outcome (PRO) measures in clinical trials as primary and secondary outcomes is increasing as more companies understand the importance of assessing the therapeutic impact of their compound from the patient's perspective. Invariably such measures are developed in US English but require administration in multinational clinical trials. As the results of such trials are pooled, it is essential that the translation and linguistic validation of the PRO measures follows a rigorous and standardised methodology.

The general aim of the translation and linguistic validation process is not only to develop translations that are semantically equivalent to the source version, but also to develop translations that are conceptually equivalent to the source version and culturally meaningful for use with the target population in the target countries.

This audio conference covers:

• The translation and linguistic validation methodology approved by regulatory agencies and conference organisations
• The review and linguistic validation methodology approved by regulatory agencies and conference organisations
• Why each of the translation and review steps is required
• The timelines required for translating and reviewing PRO measures
• Factors a company should consider when planning to use PRO measures in multinational clinical trials

About the speaker:

Darren Clayson, MSc has a background in psychology and health psychology, working in health promotion before specialising in PRO research. Prior to starting PharmaQuest Ltd. in 2005, Darren worked as a project manager in a large PRO consultancy in the UK, managing a large number of national and international outcomes research projects in a variety of areas including, among others, atrial fibrillation, COPD, diabetes, HIV, schizophrenia, sexual health, and urinary tract infection. Darren has extensive experience in conducting literature reviews, measure development and psychometric validation.

He has also given training courses in psychometric validation and Rasch analysis. He is actively involved in reviewing manuscripts for a number of journals including Quality of Life Research. He has also given lectures at British universities on research methods and health research. Since founding PharmaQuest Ltd. Darren has managed over 70 PRO translation, review and linguistic validation projects covering over 60 languages in 70 countries.

Who should attend?

• Health Outcomes Managers
• Health Outcomes Directors
• Health Economics Managers
• Marketing Managers
• Anyone using PRO data

This audio conference is rated General interest