Considerations when applying a structured benefit-risk assessment to drug delivery combination products.
Gilsenan AW, Ritchey ME, Hauber B, Andrews EB.
Structured benefit-risk assessments, like the CIRS-BRAT framework, are used to organize information in a transparent manner. The framework has been used to display benefits and risks for a particular drug or biologic to regulatory as well as other audiences.
Published examples of applying the CIRS-BRAT framework with a single drug exist, but could this framework also be used for drug delivery combination products? We reviewed the key steps of the CIRS-BRAT framework to determine whether modifications would be required.
The CIRS-BRAT framework involves
1. defining a decision frame that includes the population, timeframe, and comparator of interest,
2. identifying key benefits and risks,
3. gathering and assimilating relevant data, and
4. generating visualizations to communicate the results.
Using a triptan example, we found that the framework can be used for drug delivery combination products, but that additional considerations related to comparator, population, patient preferences, and timing may be more challenging to resolve.
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