Advice on the Design and Development Of New COAs
The team at InSpired Health Outcomes have designed and developed exceptional Clinical Outcome Assessments (in particular Patient Reported Outcome, or PRO measures) which are robustly tested to exacting standards recognised by regulators and professional societies specific to the sector.
Each COA is suitably tested with appropriate patient populations to demonstrate measurement properties, for example face validity, content validity, test and retest reliability, sensitivity to change. This ensures the developed COA:
Has good measurement properties
Is meaningful to the patient
Measures the concepts or domains, relevant to the target condition and aims of the proposed study
Asks questions about what is important to the patient
Patients' voices are at the heart of each COA we create and manage, from early design, to validation and final application. The team at InSpired Health Outcomes are responsible for developing COAs which are internationally recognised, including by regulatory bodies, such as the FDA or EMA. So, if you seek advice and guidance on the development (or application) of COAs, then please do contact us.