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The FDA guidance for industry on PROs: the point of view of a pharmaceutical company

The FDA guidance for industry on PROs: the point of view of a pharmaceutical company

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Patient reported outcomes: looking beyond the label claim.Randomized trial of safinamide add-on to levodopa in Parkinson's disease with motor fluctuations.Conceptualizing functional cognition in stroke.Impact of post-stroke cognitive impairment with no dementia on health-related quality of life.Patterns of reporting health-related quality of life across racial and ethnic groups.Quality of life after surgery of the alimentary tract.Conceptualizing functional cognition in traumatic brain injury rehabilitation.Advising on Preferred Reporting Items for patient-reported outcome instrument development: the PRIPROID.Health-related quality of life in patients with brain tumors: limitations and additional outcome measures.Patient reported endpoints for measuring clinical benefit in (high grade glioma) primary brain tumor patients.Patient-reported outcome measures in amblyopia and strabismus: a systematic review.Visual function and quality of life among visually impaired and cataract operated adults. The Pakistan National Blindness and Visual Impairment Survey.The impact of symptom interference using the MD Anderson Symptom Inventory-Brain Tumor Module (MDASI-BT) on prediction of recurrence in primary brain tumor patients.Quality-of-Life Outcomes From a Randomized Clinical Trial Comparing Antimetabolites for Intermediate, Posterior, and Panuveitis.Owner-assessed indices of quality of life in cats and the relationship to the presence of degenerative joint disease.Health-related quality of life and its relation to disease severity in boys with Duchenne muscular dystrophy: satisfied boys, worrying parents--a case-control study.Measurement equivalence using a mixed-mode approach to administer health-related quality of life instruments.Randomization to once-daily stavudine extended release/lamivudine/efavirenz versus a more frequent regimen improves adherence while maintaining viral suppression.Measuring clinical benefit: use of patient-reported outcomes (PRO) in primary brain tumor clinical trials.Guidelines for Recognition, Assessment and Treatment of Pain

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The FDA guidance for industry on PROs: the point of view of a pharmaceutical company

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2006 թուականի Հոկտեմբերին հրատարակուած գիտական յօդուած

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2006年論文

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2006年論文

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2006年論文

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Health and Quality of Life Outcomes

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The FDA guidance for industry on PROs: the point of view of a pharmaceutical company

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Fabio Arpinelli

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Francesco Bamfi

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Recommendations on health-related quality of life research to support labeling and promotional claims in the United States.

Health-related quality of life (HR-QOL) and regulatory issues. An assessment of the European Agency for the Evaluation of Medicinal Products (EMEA) recommendations on the use of HR-QOL measures in drug approval.

Methods to explain the clinical significance of health status measures.

Incorporating the patient's perspective into drug development and communication: an ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration, February 16, 2001.

Taking stock of health-related quality-of-life measurement in oncology practice in the United States.

The use of patient reported outcome measures in routine clinical practice: lack of impact or lack of theory?

Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels.

Health-related quality of life and other patient-reported outcomes in the European centralized drug regulatory process: a review of guidance documents and performed authorizations of medicinal products 1995 to 2003.

Minimal changes in health status questionnaires: distinction between minimally detectable change and minimally important change

The problem of quality of life in medicine.

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