Patient-reported outcomes in support of oncology product labeling claims: regulatory context and challenges. - Wikidata - awgldk - TriplyDB

Patient-reported outcomes in support of oncology product labeling claims: regulatory context and challenges.

Patient-reported outcomes in support of oncology product labeling claims: regulatory context and challenges.

http://www.wikidata.org/entity/Q37780539

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Patient-reported outcomes are changing the landscape in oncology care: challenges and opportunities for payers.Patient-reported outcome (PRO) assessment in clinical trials: a systematic review of guidance for trial protocol writers The impact of frailty on oral care behavior of older people: a qualitative study.Systematic collection of patient reported outcome research data: A checklist for clinical research professionals.Deterioration in quality of life (QoL) in patients with malignant ascites: results from a phase II/III study comparing paracentesis plus catumaxomab with paracentesis alone.Patient-Reported Outcomes in Oncology Drug Labeling in the United States: A Framework for Navigating Early Challenges.Advising on Preferred Reporting Items for patient-reported outcome instrument development: the PRIPROID.Quantitative challenges facing patient-centered outcomes research.A pilot study of combination intraperitoneal recombinant human endostatin and chemotherapy for refractory malignant ascites secondary to ovarian cancer.Are dental health behaviors rational, after all?

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Patient-reported outcomes in support of oncology product labeling claims: regulatory context and challenges.

http://www.wikidata.org/entity/Q37780539

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article científic

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article scientifique

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artigo científico

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bilimsel makale

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scientific article published on August 2010

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vedecký článok

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vetenskaplig artikel

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Patient-reported outcomes in s ...... latory context and challenges.

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Expert Review of Pharmacoeconomics & Outcomes Research

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Yanni Hao

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P2860

Opinion: why the variation in breast cancer survival in Europe?

The MOS 36-ltem Short-Form Health Survey (SF-36)

Patient-reported outcomes: assessment and current perspectives of the guidelines of the Food and Drug Administration and the reflection paper of the European Medicines Agency

The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology

EMEA and the evaluation of health-related quality of life data in the drug regulatory process.

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

The significance of quality of life in health care.

Health-related quality of life in non-small-cell lung cancer: methodologic issues in randomized controlled trials.

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.

Assessing tumor-related signs and symptoms to support cancer drug approval.

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407-420

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