In this section, these models are discussed with regard to inputs to, and outputs from the models, and how these models contribute to studies of tobacco products, and how they are represented in CDISC standards for submission to a regulatory authority.
"this section covers --→
We need to note "Simulation". Replaced "or"
To assess the impact to the population as a whole, estimations or real-world data reflecting product risk and behavior are used to assess changes in mortality or morbidity in a population.
Post-market (research purpose - 7/14/22 - team feels this can be handled by writing. Revisit after we're done the population modeling section)
Updating previous modeling work based on real-world evidence once the product is marketed. e.g., updating transition probabilities.
Includes additional data from the following, which serve as inputs to updating the inputs described in the previous section on population modeling:
- surveys
- obs studies (longitudinal cross-sectional)
- EHR (retrospective)
Parameters used as inputs to population modeling; not subject-level data.
Models are made up of inputs, programs/coding, and outputs
- inputs: come from specific studies, published lit, gov't databases (census data, etc)
- everything has to be extrapolated to the population level; inputs are not subject-level
- categories of inputs
- Product risk
- need input from Unknown User (a.paredes) . Come back to later, time permitting
- transition probabilities/rates (behavior)
- initial population (file) - describing states of tobacco use covered by the model
- transition probability (file)
- population attributes broken down by demographic characteristics (files)
- birth rate
- morbidity/mortality
- initial tobacco prevalence
- immigration rates
- Product risk
- programs/coding
- ...
- Outputs
- ...
Overview
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