PMC21 PATIENT-REPORTED OUTCOMES IN PRODUCT DEVELOPMENT GUIDANCE
نویسندگان
چکیده
منابع مشابه
Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance
This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling (see appendix point 1). It does not address the use of PRO instruments for purposes beyond e...
متن کاملPatient-Reported Outcomes, Patient-Reported Information
Internet communication is developing. Social networking sites enable patients to publish and receive communications very easily. Many stakeholders, including patients, are using these media to find new ways to make sense of diseases, to find and discuss treatments, and to give support to patients and their caregivers. We argue for a new definition of patient-reported information (PRI), which di...
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Although some symptoms of dermatologic diseases, such as pruritus and pain, can be subjectively assessed only by patients, the most commonly used endpoints in dermatology drug research traditionally have been clinician-reported outcomes. Research has found that patient-reported outcomes (PROs) were included in only one-quarter of 125 trials conducted between 1994 and 2001. Our objective was to ...
متن کاملAssuring the patient centeredness of patient-reported outcomes: content validity in medical product development and comparative effectiveness research.
Not all patient-reported outcomes (PROs) are patient centered, and not all patient-centered outcomes are patient reported. The essential characteristic of a patient-centered approach to outcome measurement is that it assesses concepts (i.e., healthrelated phenomena) that are considered most important by members of a given target population, based on direct input from representatives of that pop...
متن کاملPatient-reported Outcomes
Key points Many gastrointestinal diseases are symptomdriven, so the patient’s perspective is particularly important in this area. Patient-reported outcomes (PROs) provide essential information that objective measures and clinician assessment may fail to capture. PROs can be measured in a scientific, reliable, and valid manner. Generic, disease-specific and treatmentspecific PRO instruments exis...
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ژورنال
عنوان ژورنال: Value in Health
سال: 2010
ISSN: 1098-3015
DOI: 10.1016/s1098-3015(10)72064-7