Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making
Free
Guidance 4 will address methodologies, standards, and technologies that may be used for the collection, capture, storage, and analysis of clinical outcome assessment (COA) data. The guidance will also address methods to better incorporate COAs into endpoints that are considered significantly robust for regulatory decision-making. This includes methods to define meaningful change in a COA-based endpoint and interpretation of results. The guidance will include information on the format and content required for regulatory submissions incorporating patient experience, in particular COA data.
Owner (organization)
Target audience
Patients, Pharmaceutical companies or industry , Researchers (investigators and academic researchers), Other
Types
Guidance
Formats
Online e-learning
Levels
Beginner
Language
English
Accessibility
Not applicable
Certification
No
Patients involved
No
Length of training (in hrs)
1
Version date/number
03 Jan 2020
PFMD last access
28 Nov 2020
