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Patient-reported outcomes are changing the landscape in oncology care: challenges and opportunities for payers.

Patient-reported outcomes are changing the landscape in oncology care: challenges and... A patient-reported outcome (PRO) is a subjective report that comes from a patient without interpretation by a clinician. Because of the increasingly significant role of PROs in the development and evaluation of new medicines, the US Food and Drug Administration (FDA) issued a formal guidance to describe how PRO instruments will be reviewed and evaluated with respect to claims in approved medical product labeling. Meanwhile, PROs continue to appear in oncology clinical trials more frequently; however, it is unclear how payers and policymakers can use PRO data in the context of decision-making for cancer treatments. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png American health & drug benefits Pubmed

Patient-reported outcomes are changing the landscape in oncology care: challenges and opportunities for payers.

American health & drug benefits , Volume 6 (5): 11 – Jul 3, 2014

Patient-reported outcomes are changing the landscape in oncology care: challenges and opportunities for payers.


Abstract

A patient-reported outcome (PRO) is a subjective report that comes from a patient without interpretation by a clinician. Because of the increasingly significant role of PROs in the development and evaluation of new medicines, the US Food and Drug Administration (FDA) issued a formal guidance to describe how PRO instruments will be reviewed and evaluated with respect to claims in approved medical product labeling. Meanwhile, PROs continue to appear in oncology clinical trials more frequently; however, it is unclear how payers and policymakers can use PRO data in the context of decision-making for cancer treatments.

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ISSN
1942-2962
pmid
24991362

Abstract

A patient-reported outcome (PRO) is a subjective report that comes from a patient without interpretation by a clinician. Because of the increasingly significant role of PROs in the development and evaluation of new medicines, the US Food and Drug Administration (FDA) issued a formal guidance to describe how PRO instruments will be reviewed and evaluated with respect to claims in approved medical product labeling. Meanwhile, PROs continue to appear in oncology clinical trials more frequently; however, it is unclear how payers and policymakers can use PRO data in the context of decision-making for cancer treatments.

Journal

American health & drug benefitsPubmed

Published: Jul 3, 2014

There are no references for this article.