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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US Food and Drug Administration review of statistical analysis of patient-reported outcomes in lung cancer clinical trials approved between January, 2008, and December, 2017

1 October 2019 - With the advent of patient-focused drug development, the US FDA has redoubled its efforts to review patient-reported ...

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AI needs patients’ voices in order to revolutionise health care

30 September 2019 - Patients’ stories — what doctors call patient histories — are the bedrock of medicine. “Listen to ...

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FDA issues draft guidance on patient-focused drug development: methods to identify what is important to patients

30 September 2019 - Today the U.S. FDA issued a draft guidance on Patient-Focused Drug Development: Methods to Identify What Is ...

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Health‐related quality of life in oncology drug reimbursement submissions in Canada: a review of submissions to the pan‐Canadian Oncology Drug Review

23 September 2019 - In Canada, CADTH evaluates and makes recommendations for the reimbursement of cancer drugs. One component of ...

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In praise of studies that use more than one generic preference-based measure

12 July 2019 - Generic preference-based measures of health-related quality of life are widely used as outcome measures in cost-effectiveness and ...

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Validation of patient reported outcomes: a low bar

3 July 2019 - It used to be that if we wanted to assess a patient’s back pain, we would evaluate ...

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The EORTC Quality of Life Questionnaire for cancer patients (QLQ‐C30): Australian general population reference values

17 June 2019 - Mercieca‐Bebber and colleagues set out generate Australian general population reference values for the EORTC Quality of ...

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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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