FDA advances the science of patient input by seeking specific feedback on patient preferences that may impact regulatory decisions on medical devices

2 May 2019 - The U.S. FDA today opened a docket to receive input from stakeholders on a new priority ...

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A review of patient reported outcomes labelling for oncology drugs approved by the FDA and the EMA (2012-2016)

31 January 2019 - In recent years, the FDA has granted patient-reported outcome labelling to very few oncology drugs. ...

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BIO, Allergan and Roche call for FDA flexibility with patient experience data

13 September 2018 - Industry group BIO and biopharma companies Allergan and Roche are calling for the FDA to be ...

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Statistical analysis of patient-reported outcome data in randomised controlled trials of locally advanced and metastatic breast cancer: a systematic review

1 September 2018 - Although patient-reported outcomes, such as health-related quality of life, are important endpoints in randomised controlled trials, there ...

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Patient reported outcome measures in the FDA pilot compendium: meeting today’s standards for patient engagement in development?

7 August 2018 - In 2016, the FDA released a pilot clinical outcome assessment compendium intended to foster patient-focused drug development.  ...

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How patient preferences contribute to regulatory decisions for medical devices

25 September 2017 - Since we launched our Patient Preference Initiative as part of our medical device regulatory decision-making process ...

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Patient reported outcomes — are they living up to their potential?

5 July 2017 - There is a growing chorus of support for measuring patient-reported outcomes in clinical care.  ...

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Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards

19 October 2016 - Measures of health-related quality of life and other patient-reported outcomes generate important data in cancer randomised trials ...

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Patient reported outcomes labeling for products approved by the Office of Hematology and Oncology Products of the US FDA (2010-2014)

23 May 2016 - Ari Gnanasakathy et al. have reviewed the use of patient-reported outcome (PRO) data in medical product labeling ...

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Integrating patients’ views in clinical studies of anti-cancer medicines

22 April 2016 - The EMA has published new guidance on the use of patient-reported outcome (PRO) measures in oncology ...

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