Blog
RSS FeedPosted by Michael Wonder on 14 Sep 2021
EMA study reveals need for RWE framework, submission structure
14 September 2021 - The EMA has identified a need for more consistency in how real world evidence is submitted. ...
Posted by Michael Wonder on 31 Aug 2021
Real world outcomes associated with new cancer medicines approved by the FDA and EMA: a retrospective cohort study
August 2021 - Real world data studies are increasingly used to support regulatory approvals, reimbursement decisions, and changes in clinical practice ...
Posted by Michael Wonder on 24 Aug 2021
ICER uses observational real world evidence to update 2018 assessment on therapies for hereditary angioedema, finds therapies far less cost effective than earlier estimates
24 August 2021 - Patients initiating therapy in real world dataset had less frequent baseline attack rates than rates from clinical ...
Posted by Michael Wonder on 11 Aug 2021
‘We don’t unlearn’: what the pandemic has taught regulators about real world data
11 August 2021 - During the pandemic, regulatory agencies deployed emergency measures left and right to speed care to patients. ...
Posted by Michael Wonder on 05 Aug 2021
From Our Perspective: FDA approval demonstrates the role of real world evidence in regulatory decision-making on drug effectiveness
4 August 2021 - In this CDER From Our Perspective, experts discuss the recent FDA approval of Prograf (tacrolimus) in combination ...
Posted by Michael Wonder on 21 Jul 2021
Fit for purpose real world data assessments in oncology: a call for cross stakeholder collaboration
21 July 2021 - Real world evidence remains a promising frontier in evidence generation to support improved health related patient outcomes. ...
Posted by Michael Wonder on 16 Jul 2021
FDA approves new use of transplant drug based on real world evidence
16 July 2021 - Today, the U.S. Food and Drug Administration approved a new use for Prograf (tacrolimus) based on a ...
Posted by Michael Wonder on 15 Jun 2021
Health care funding decisions and real world benefits: reducing bias by matching untreated patients
14 June 2021 - Governments and health insurers often make funding decisions based on health gains from randomised controlled trials. ...
Posted by Michael Wonder on 04 Jun 2021
Advancing international collaboration on COVID-19 real world evidence and observational studies
4 June 2021 - Medicines regulators from around the world discussed the importance of global collaboration and information sharing in relation ...
Posted by Michael Wonder on 31 May 2021
Roche Canada announces collaboration to improve access to personalised health care with real world evidence
28 May 2021 - BC Cancer, CPHIN and Roche Canada will co-create an evidence-generating framework to leverage real-world data and facilitate ...
Posted by Michael Wonder on 19 May 2021
Leading real world data and analytics organisations form industry coalition to advance policies to support regulatory use of real world evidence
19 May 2021 - RWE Alliance Launched by Aetion, Flatiron Health, IQVIA, Syapse, and Tempus. ...
Posted by Michael Wonder on 17 May 2021
Quality, access, and the use of real world data by payers: where are we now? Where do we want to be in the future?
15 May 2021 - One of the biggest challenges payers face today is determining the value of innovative therapies in diseases ...
Posted by Michael Wonder on 28 Apr 2021
Do existing real world data sources generate suitable evidence for the HTA of medical devices in Europe? Mapping and critical appraisal
28 April 2021 - Technological and computational advancements offer new tools for the collection and analysis of real world data. ...
Posted by Michael Wonder on 28 Apr 2021
NICE signs up to join the GetReal Institute
28 April 2021 -NICE’s ambition complements the GetReal Institute’s core mission to facilitate the adoption and implementation of real-world evidence ...
Posted by Michael Wonder on 12 Apr 2021
ICER to use Aetion observational RWE to update value assessment of treatments for hereditary angioedema
12 April 2021 - New ICER pilot will incorporate more than 24 months of observational real world demographic, utilisation, and cost ...