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In this section, the inputs to these models and how they are represented in CDISC standards for submission to a regulatory authority are discussed. “Model outputs are not currently covered in this section but may be covered in a later release.” However, regulatory agencies expect full information to replicate the analysis based in the outputs.

Chris to look for language pointing back to CTP for full guidance…

Transition into discussion of examples - to be discussed:

Selection of initial model input parameters is an important step during model development. Input parameters are typically chosen to represent characteristics of the entire population: transitional probabilities (initiation, cessation, quitting, switching) and health outcome (mortality and/or morbidity rates). The initial values of these parameters are typically estimated from sources representative of the population, such complex probability population survey and census. 

Categories of Inputs

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• need input from Unknown User (a.paredes) . Come back to later, time permitting

Examples

Initial Population

• demographics (age, gender, and race)
• birth rate "if open system"
• morbidity/mortality 
• initial tobacco prevalence
• immigration rates "If open system"

Transition probabilities/rates for initial population

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• 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 

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