ISCTM Session 2 - Clinician-Reported Outcomes in Multinational CNS Trials: Practical Guidance on Translation and Cultural Adaptation
International Society for CNS Clinical Trials and Methodology (ISCTM)
Hotel Le Meridien Etoile, Paris FRANCE
On September 1st, 2017, Santium will join a symposium session at the ISCTM 2017 Autumn Conference to discuss the impact of language, culture and cultural bias on data integrity in international clinical trials.
The rapid globalization of CNS clinical trials has outpaced the development of adequate criteria for the translation and adaptation of clinician-reported outcomes. Published studies reveal substantial variations in the application of translation/adaptation methodologies, standards, and resources. As a result, the ability to detect differences supporting critical new treatments may be compromised by the complexities associated with measuring psychiatric symptoms across multiple regions and languages.
Developing consensus on ways to balance cost/time against approaches to optimize the validity and reliability of clinician-reported outcomes across linguistic, cultural and educational barriers is essential to improving the success of CNS treatment development.
The goal of this session is to report on the development of practical guidelines and standards to elevate the validity and reliability of Clinician-Reported Outcomes in multinational clinical trials.
Santium explores this subject at ISCTM 2017 in a joint day session with the European College of Neuropsychopharmacology (ECNP).
Friday, September 1, 2017
Hotel Le Meridien Etoile
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Overview of differences in difficulty in translating PROs and ClinROs, and how language and culture affect communication between clinicians and patients, patient recruitment, and data quality.
Real world examples of data collection challenges resulting from cultural bias.
An introduction to a practical guidance for translation and cultural adaptation of clinician-reported outcome measures.
Session Level: Intermediate – Assumes working knowledge of translation methods of rating scales.
Focus on Competencies: Trial Data Collection, Clinical Trials Processes, Roles and Responsibilities, Rating Subjects, Data Quality
Target Audience: Study Manager, COA Lead, Regulatory Director, Raters, Study Designers, Rater Trainers
WORKING GROUP PRESENTATION
Monika Vance | Working Group Session | ISCTM Autumn Conference 2014, Boston, MA
THE FDA PRO GUIDANCE – A REVIEW: PURPOSE AND USE
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