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Abstract:
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Many methods can be used to estimate benefit and risk, and each method has drawbacks. Assessments frequently include information about effectiveness and efficacy, safety, means of therapy implementation, duration of use and effect, other characteristics that may inform assessments, and patients' willingness (and unwillingness) to tolerate therapies. We will discuss mixed methods approaches to combine qualitative and quantitative work integrating patient input and experience to assess patient preference information, inform choices about study outcome measurements, and inform benefit risk assessments. To understand if the data collected is a robust assessment of patient information, we will describe examples of the broad range of patients that should be involved in this work. We will discuss methods and needs for communication about relative attributes of treatment options, how current treatment options meet and do not meet patient needs, and risk management strategies; evidence and uncertainties; and the relevance of clinical endpoints to describe how patients feel, function, and survive.
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