Type of Scientific Advice Offered

The Scientific Advice Program offers advice on prospective drug development plans to applicants.

The focus of Scientific Advice is on development strategies and evidence requirements for health technology assessments. Scientific Advice is provided from a Canadian payer perspective.

We offer Scientific Advice on both clinical and economic aspects of drug development.

Scientific Advice may be requested on clinical topics such as:

• Target population
• Choice of comparator
• Trial design
• End points for reimbursement
• Statistical issues (stratification, subgroups).

Scientific advice may be requested on economic topics such as:

• Population
• Choice of comparators
• Choice of economic model
• Data used to populate model
• Time horizon and extrapolation hypothesis
• Utility values
• Resource utilization data.

The Scientific Advice Program does not offer Scientific Advice on:

• Regulatory requirements
• Product pricing
• Pre-clinical data.

In addition, the Scientific Advice Program does not offer Scientific Advice on the analysis of existing data (post-phase III, or pivotal, trials) or on what existing data should be submitted to the Common Drug Review (CDR) or the pan-Canadian Oncology Drug Review (pCODR). For questions on submission requirements for CDR or pCODR, please refer to the procedural documents for CDR or pCODR, or contact [email protected].