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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Health Canada’s position on the CADTH guidance for reporting RWE to support decision-making

18 May 2023 - Canada’s CADTH collaborated with Health Canada and other stakeholders to develop the guidance for reporting real world ...

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Collaboration creates roadmap in Canada to report real world evidence studies

16 May 2023 - CADTH, Health Canada, and the Institut national d’excellence en santé et en services sociaux (INESSS) are ...

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CADTH formalises offering on real-world evidence through its scientific advice program

25 April 2023 - During a 1-year learning period, CADTH expanded its Scientific Advice program to include advice on real-world evidence ...

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DARWIN EU has completed its first studies and is calling for new data partners

28 March 2023 - DARWIN EU, the Data Analysis and Real World Interrogation Network, has accomplished its first year of establishment. ...

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Replacing RCTs with real world data for regulatory decision-making: a self-fulfilling prophecy?

2 March 2023 - Real world data are advocated as an alternative approach to randomised clinical trials for closing knowledge gaps ...

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Efficient RCTs with real world data for benefit assessments: accelerating evidence-based care

2 March 2023 - Together with colleagues from the Belgian HTA agency KCE, three employees of IQWiG in the BMJ are ...

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