Blog
RSS FeedPosted by Michael Wonder on 18 May 2022
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. ...
Posted by Michael Wonder on 17 May 2022
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 ...
Posted by Michael Wonder on 06 May 2022
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 ...
Posted by Michael Wonder on 11 Apr 2022
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 ...
Posted by Michael Wonder on 03 Mar 2022
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 ...
Posted by Michael Wonder on 16 Dec 2021
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 ...
Posted by Michael Wonder on 24 Nov 2021
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 ...
Posted by Michael Wonder on 04 Aug 2021
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 ...
Posted by Michael Wonder on 10 Jun 2021
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 ...
Posted by Michael Wonder on 06 Oct 2020
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 ...
Posted by Michael Wonder on 31 Aug 2020
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 ...
Posted by Michael Wonder on 23 Jun 2020
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. ...
Posted by Michael Wonder on 05 Jan 2020
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 ...
Posted by Michael Wonder on 03 Dec 2019
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 ...
Posted by Michael Wonder on 15 Oct 2019
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 ...