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. ...

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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 ...

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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 ...

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‘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. ...

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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 ...

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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. ...

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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 ...

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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.  ...

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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 ...

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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 ...

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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. ...

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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 ...

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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.  ...

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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 ...

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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 ...

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