The role and value of real-world evidence in health technology decision-making in France, Germany, Italy, Spain, and the UK: insights on external control arms

22 April 2025 - Real-world evidence is increasingly used and accepted by health technology assessment (HTA) bodies as supportive evidence ...

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Real-world evidence to support health technology assessment and payer decision making: is it now or never?

31 March 2025 - The aim of this policy article is twofold: (i) to provide a summary and update of recent ...

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The use of real world data for estimating relative treatment effects in NICE health technology assessment submissions: a review

1 February 2025 - This paper investigates the current use of real world data for estimating relative treatment effects in NICE ...

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CDER establishes new Center for Real World Evidence Innovation

12 December 2024 - Today, the US FDA’s Center for Drug Evaluation and Research (CDER) announced the new CDER Center ...

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Canada’s Drug Agency taking steps to expand access to real world evidence

7 August 2024 - Canada’s Drug Agency has published a summary report from its time-limited Industry Task Force.  ...

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Real world evidence submissions to the Center for Biologics Evaluation and Research

26 June 2024 - As part of the reauthorisation of the Prescription Drug User Fee Act (PDUFA VII), FDA committed ...

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COTA announces extended collaboration with FDA to advance the use of real world data in cancer research

22 May 2024 - Today, COTA announced an extension of its research collaboration with ​​the US FDA Oncology Center of Excellence.  ...

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Acceptability of using real world data to estimate relative treatment effects in health technology assessments: barriers and future steps

15 May 2024 - Evidence about the comparative effects of new treatments is typically collected in randomised controlled trials (RCTs). In ...

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Launch of new HMA-EMA catalogues of real world data sources and studies

15 February 2024 - The EMA and the Heads of Medicines Agencies have launched two public electronic catalogues: one for ...

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Updates to the HTA Review Research and Analysis papers collection: draft HTA expert paper published

22 November 2023 - The draft paper 'Optimising the availability and use of real world data and real world evidence to ...

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FDA issues final guidance on considerations for the use of real world data and real world evidence to support regulatory decision-making for drugs and biological products

30 August 2023 - Today, the US FDA issued a final guidance for industry titled Considerations for the Use of Real-World ...

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CADTH to establish industry task force on real world data for post market drug evaluations

18 August 2023 - CADTH is establishing an industry task force that will build upon the recently released guidance for reporting ...

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Facilitating review of real world data studies: the oncology QCARD initiative

27 June 2023 - Expanding ways to generate evidence can lead to an array of benefits for medical product development, including ...

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Use of real world evidence in regulatory decision making – EMA publishes review of its studies

23 June 2023 - Real world evidence from studies led by regulators can complement evidence from other sources including clinical trials.  ...

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Guidance for reporting real world evidence

31 May 2023 - CADTH has partnered with Health Canada, the Institut national d’excellence en santé et en services sociaux (INESSS), ...

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