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Evaluate data collected during drug development to maximize the value of a therapeutic product.

Studies (prospective or retrospective) utilizing data obtained from "real world settings" , and is outside the tight controls of a clinical trial design.

Summarizes the results of research (that meet pre-defined eligibility criteria for inclusion) and provides a high level of evidence on the outcomes assessed.

Compare alternative treatments that lead to similar health outcomes.

Research method for documenting clinical, economic, and or humanistic outcomes of actual medical practice absent the constraints of a more formal experimental design. See also Pragmatic Clinical Trials.

Assessment of health outcomes directly reported by the patient who experienced it, without interpretation of the patient's response by a clinician.

Develop value story tailored to a payer audience that will determine the appropriate price for treatment.

Assess effects, costs and economic outcomes of treatment. These include cost-effectiveness models and budget impact models.

Economic evaluation in which costs and benefits (outcomes) are expressed in monetary units, to determine if the benefits of an intervention outweigh the costs.

Summary document that presents clinical, economic, and humanistic value of an intervention and associated disease state with the supporting evidence, formulated from the perspective of a particular stakeholder (manufacturer, payer, provider, HTA agency, etc.). See also HTA Submission.