{ Psychometric development and validation }
Psychometric Development and Validation
The FDA Guidance for Industry: Patient-Reported Outcome Measures requires rigorous psychometric design and validation of instruments in order to secure a label claim for a new or currently marketed product. Applied equally to PRO claims in existing labels as well as future filings, this requires companies to retrofit validation for existing instruments, as well as develop new instruments specific to patients, disease states, and outcomes of interest. Our team brings with it an intimate knowledge of the FDA process, including experience defending claims in existing labels and designing trials to support the inclusion of claims in new drug filings. In collaboration with Early Clinical Development, we can also support the inclusion of PRO endpoints in Phase II and III trials.
Our skills include:
- Questionnaire design and validation
- PRO endpoints in Phase II, III, and IV trials
- Support for FDA filings for PRO label claims
