What advice can be requested?
Scientific Advice is prospective in nature. It allows input on development plans which have the potential to be amended after the advice. NICE will comment on the manufacturer's proposed development plans. Scientific advice can be given on many issues connected with the development of evidence for post-regulatory evaluation bodies.
- Interpretation of NICE technology appraisal methods guidance and its relevance for the product's evidence development plans.
Research design considerations or preferences to support each proposed indication. For example:
- study population
- type of study.
Economic evaluation design considerations or preferences. For example:
- form of evaluation and approaches to benefit measurement
- modelling versus trials
- relevant trial(s) for economic evaluation
- approaches to the generation of quality-adjusted life years (QALYs).
Methods issues. For example:
- selection of instruments or research to derive QALYs
- extrapolation of long-term outcomes
- planning for indirect comparisons.
Considerations and insights from existing models. For example:
- expected value of perfect information (EVPI)
- calculations to highlight greatest areas of uncertainty and assist with trial design
- Bayesian simulations.
What advice cannot be requested?
Scientific advice focuses on development strategies rather than pre-evaluation of data to support a submission to NICE. The following remain outside of the scope of NICE scientific advice:
- requests directly related to submissions to NICE will not be accepted in the critical period shortly before submission
- advice on pricing for a product
- advice on regulatory requirements
- advice on pre-clinical data
This page was last updated: 24 August 2012