Toward incorporating health-related quality of life as co-primary endpoints in clinical trials: time to achieve clinical important differences and quality of life profiles

16 May 2022 - Besides morbidity and mortality, quality of life is a key outcome of cancer treatments.  ...

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Ethical considerations for the inclusion of patient reported outcomes in clinical research

17 May 2022 - An international consensus Delphi process was developed according to the Enhancing the Quality and Transparency of Health ...

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Patient reported outcome assessment must be inclusive and equitable

5 May 2022 - Patient reported outcomes are increasingly collected in clinical trials and in routine clinical practice, but strategies ...

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A review of patient reported outcome labelling of FDA approved new drugs (2016-2020): counts, categories and comprehensibility

8 April 2022 - A review of new drug approvals by the U.S. FDA for 2006 to 2015 showed that approximately ...

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Criticism of study planning: patient-reported endpoints are often collected far too briefly

3 March 2022 - A striking example: abemaciclib in advanced breast cancer. Shortened data on quality of life, symptoms and side ...

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Patient reported endpoints underrepresented in product information on new drugs

15 December 2021 - An IQWiG team analysed the extent to which patient reported outcomes, which were recorded as endpoints ...

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Review of real world evidence and patient reported outcomes

24 November 2021 - The TGA recently commissioned a review into its usage of real world evidence and patient reported ...

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Collecting patient reported outcomes in cancer clinical trials

3 August 2021 - To help patients with cancer learn more about how treatment may affect their quality of life, the ...

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Core patient reported outcomes in cancer clinical trials

9 June 2021 - This guidance provides recommendations to sponsors for collection of a core set of patient reported clinical outcomes ...

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Demystifying the estimand framework: a case study using patient-reported outcomes in oncology

1 October 2020 - Patient-reported outcome measures describe how a patient feels or functions and are increasingly being used in benefit–risk ...

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FDA releases draft guidance on PROs for device manufacturers

31 August 2020 - Device manufacturers have new draft guidance from the US FDA for the selection of patient-reported outcome ...

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FDA announces first of its kind pilot program to communicate patient reported outcomes from cancer clinical trials

23 June 2020 - The U.S. FDA today launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence.  ...

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Adding patient reported outcomes to Medicare’s oncology value-based payment model

2 January 2020 - On 1 November 2019, the Centers for Medicare & Medicaid Services Innovation Center released details of a ...

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Clarifying the meaning of clinically meaningful benefit in clinical research: noticeable change vs valuable change

2 December 2019 - Recent years have witnessed an increasing focus on the input of patients, their caregivers, or both to ...

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Patient experience data: researchers call for more consistency from FDA

14 October 2019 - Researchers at drug maker Sanofi are calling on the US FDA to make its publication of ...

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