Blog
RSS FeedPosted 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FDA releases draft guidance on PROs for device manufacturers
31 August 2020 - Device manufacturers have new draft guidance from the US FDA for the selection of patient-reported outcome ...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 ...
Posted by Michael Wonder on 01 Oct 2019
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 ...
Posted by Michael Wonder on 30 Sep 2019
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 ...
Posted by Michael Wonder on 30 Sep 2019
FDA issues draft guidance on patient-focused drug development: methods to identify what is important to patients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 ...
Posted by Michael Wonder on 23 Sep 2019
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 ...
Posted by Michael Wonder on 14 Jul 2019
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 ...
Posted by Michael Wonder on 03 Jul 2019
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 ...
Posted by Michael Wonder on 17 Jun 2019
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 ...
Posted 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 ...