Blog
RSS FeedPosted by Michael Wonder on 02 May 2019
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 ...
Posted by Michael Wonder on 31 Jan 2019
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. ...
Posted by Michael Wonder on 13 Sep 2018
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 ...
Posted by Michael Wonder on 31 Aug 2018
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 ...
Posted by Michael Wonder on 08 Aug 2018
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. ...
Posted by Michael Wonder on 26 Sep 2017
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 ...
Posted by Michael Wonder on 05 Jul 2017
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. ...
Posted by Michael Wonder on 19 Oct 2016
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 ...
Posted by Michael Wonder on 24 May 2016
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 ...
Posted by Michael Wonder on 22 Apr 2016
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 ...