Measurement strategy development
Support in measurement strategy development
With our in-depth knowledge of regulatory and reimbursement authority requirements and expectations for PRO instruments and endpoints we are the ideal partner to help you with all aspects of measurement strategy development. This can vary from putting together an aspirational measurement strategy for inclusion in a target product profile in early stage clinical development, to performing extensive literature reviewing, qualitative research and/or quantitative studies to help refine your phase III measurement strategy, select COA/PRO instruments, define endpoints and write analysis plans. We possess both the strategic insight regarding regulatory requirements for PRO/COA endpoints and practical knowledge of what it takes to run COA/PRO development or evaluation studies to help you build a fit for purpose strategy that is feasible while helping you meet your goals.
Provision of expertise in endpoint development
At Adelphi Values we understand that endpoints and instruments are not synonymous. Endpoint definition includes specification of the timepoints that will be included, what level of change in the COA instrument score is expected, not to mention consideration of scoring. Drawing upon our expertise in both instrument development, psychometrics and regulatory expectations for COA endpoints we have the insight to advise clients on defining optimal endpoint(s) for a given instrument. We can also provide support to ensure endpoints are optimally described and documented in protocols, statistical analysis plans and regulatory submission documents.
Sound input in trial design
There are a number of success factors required to optimize investment and inform clinical decision making:
- Right choice of instrument
- Instrument psychometric evaluation
- Optimal timing of assessments
- Statistical analysis
- Timely reporting of PRO results
- Clear strategy for interpreting PRO data in terms of clinical relevance
We can provide advice on measurement aspects of drug development plans and clinical trial protocols:-
- Literature reviews to identify appropriate COAs
- Mode of administration and timing of assessments
- PRO hypothesis development
- MID development/specification
- Responder definition development/specification
Our in-depth understanding of approaches for the selection, development, validation and implementation of PRO instruments is grounded in a strong understanding of regulatory expectations and standards. However, we also have a proven track record of developing PRO instruments for use beyond supporting label claims, and can provide creative solutions to maximise the value of PRO data in reimbursements submissions and to support other wider market access activities.