DARWIN EU welcomes first data partners

23 November 2022 - EMA has selected the first set of  data partners to collaborate with DARWIN EU, the Data Analysis ...

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CADTH launches consultation on real world evidence reporting guidance

10 November 2022 - Today, CADTH, on behalf of the Real World Evidence Steering Committee, launched a public consultation to ...

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Can we use existing guidance to support the development of robust real world evidence for health technology assessment/payer decision-making?

2 November 2022 - Advances in the digitisation of health systems and expedited regulatory approvals of innovative treatments have led to ...

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A perspective on life cycle health technology assessment and real world evidence for precision oncology in Canada

25 October 2022 - Health technology assessment can be used to make healthcare systems more equitable and efficient. Advances in precision ...

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Advancing real world evidence program

19 October 2022 - As announced in the Federal Register notice published on 20 October 2022, the FDA is conducting an ...

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HARmonized protocol template to enhance reproducibility of hypothesis evaluating real world evidence studies on treatment effects: a good practices report of a joint ISPE/ISPOR Task Force

12 October 2022 - Ambiguity in communication of key study parameters limits the utility of real-world evidence studies in health care ...

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High quality data to empower data-driven medicines regulation in the European Union

10 October 2022 - EMA and the Heads of Medicines Agencies in the EU Member States are moving ahead with ...

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NICE recommends NHS collects real world evidence on devices that monitor people with Parkinson’s disease

27 September 2022 - Five promising technologies that could help improve symptoms and quality of life for people with Parkinson’s disease ...

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FDA finalises guidance on submitting RWD/RWE in application cover letters

13 September 2022 - To help better track submissions that include real world data and real world evidence, the US ...

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Submitting documents using real world data and real world evidence to FDA for drug and biological products

8 September 2022 - To facilitate FDA’s internal tracking of submissions to the Agency that include real world data and real ...

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Clinical trials: real world data plays early role in efforts to increase diversity

5 September 2022 - The use of real world data to help design clinical trials is nothing new but increasingly it ...

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Reproducibility of real world evidence studies using clinical practice data to inform regulatory and coverage decisions

31 August 2022 - Studies that generate real world evidence on the effects of medical products through analysis of digital data ...

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Real-world data can help expedite drug approvals for serious diseases with few options

10 August 2022 - My grandmother was diagnosed with dementia in the early 2000s. We started taking it seriously when she ...

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Introducing CADTH’s RWE Guidance Working Group

9 August 2022 - CADTH is pleased to announce the introduction of the Real-World Evidence Guidance Working Group.  ...

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Connecting electronic health records to clinical trials: how to embrace the promise of real world data

3 August 2022 - We all know that real world data from electronic health records could boost clinical trial efficiency ...

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