Many Clinical Outcome Assessments (COAs) designed for use within Central Nervous System (CNS) indications, particularly clinician reported outcomes (ClinROs), were developed prior to the release of the 2009 FDA guidance relating to the use of patient reported outcome measures (PROMs) in clinical development and pre-dated the Patient-Focused Drug Development (PFDD) guidance. Consequently, they do not meet the current regulatory standards for outcome measures in clinical trials. The use of ClinROs as primary and secondary efficacy endpoints requires considerable effort to ensure (1) compliance with this guidance and (2) appropriate implementation of the selected ClinRO over the course of a trial.

Sponsors need to generate evidence to support the content validity and psychometric properties of a ClinRO and maintain sufficient inter- and intra-rater reliability in its implementation throughout the pivotal trial. Challenges can occur at any stage, putting clinical development programs at risk.

This webinar will provide insights on the current CNS-focused COA landscape, PFDD guidance, what this means for legacy COAs (most notably ClinROs), recommendations for improving detection of treatment benefits, and ensuring optimal COA endpoint protection.

• What are the current industry and regulatory trends, and what is their impact on clinical development in CNS?
• What does it mean that a ClinRO is fit-for-purpose in the context of use?
• What are the key challenges with CNS ClinRO implementation over the course of a trial?
• How can the industry overcome these challenges and bring effective therapies to patients more quickly?

Key speakers

Jean Paty
Vice President, Patient Centered Solutions,
IQVIA

Betsy Williams,
Director, Scientific Services, Patient Centered Solutions,
IQVIA

Stella Karantzoulis, PhD, ABPP-CN,
Senior Principal, Patient Centered Solutions,
IQVIA

Cristian Sirbu, PhD, PsyD, MSHI
Principal, Cronos, an IQVIA Business