Use of real world evidence to support FDA approval of oncology drugs

8 October 2020 - Real world evidence has gained increased attention in recent years as a complement to traditional clinical trials.  ...

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ISPOR’s real world evidence transparency initiative: creating a road map that builds trust

5 October 2020 - Transparency of Data, Methods, Analyses, and Results Will Increase Confidence in Study Credibility. ...

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Real world evidence from a narrow therapeutic index product (levothyroxine) reflects the therapeutic equivalence of generic drug product

5 October 2020 - The National Institute of Diabetes and Digestive and Kidney Diseases reports that almost 5% of the U.S. ...

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Taking steps toward transparency in real world evidence studies

22 September 2020 - The level of trust in health economics and outcomes research studies has been an on-going concern owing ...

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Real world data for health technology assessment for reimbursement decisions in Asia: current landscape and a way forward

15 September 2020 - There is growing interest globally in using real world data and real-world evidence for health technology assessment.  ...

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Real world evidence to support payer/HTA decisions about highly innovative technologies in the EU—actions for stakeholders

3 September 2020 - There are divergent views on the potential of real world data to inform decisions made by regulators, ...

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Global regulatory workshop on COVID-19 real-world evidence and observational studies

31 July 2020 - Vaccines surveillance and vigilance, collaboration on pregnancy studies and building international patient cohorts were the main ...

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Harnessing real world data for regulatory use and applying innovative applications

22 July 2020 - A vast quantity of real world data are available to health care researchers.  ...

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EMA sets up infrastructure for real-world monitoring of COVID-19 treatments and vaccines

21 July 2020 - EMA has now set up an infrastructure to support the monitoring of the efficacy and safety ...

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NICE partners with Flatiron Health to develop real world evidence research methodologies

14 July 2020 - Collaboration will help NICE expand use of real world data in service of better outcomes for UK ...

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Real world evidence use in assessments of cancer drugs by NICE

10 July 2020 - Single technology assessments published by NICE from April 2011 to October 2018 that evaluated cancer treatments were ...

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EMA commissions independent research to prepare for real world monitoring of COVID-19 vaccines

27 May 2020 - EMA is engaging early with researchers to ensure that a European infrastructure will be in place to ...

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(COVID-19) update: FDA collaborations promote rigorous analyses of real world data to inform pandemic response

19 May 2020 - Today, the FDA is announcing another step in our effort to harness diverse streams of data to ...

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Meeting highlights from ICMRA global regulatory workshop on COVID-19 observational studies and real world data

16 April 2020 - Observational studies of data generated in clinical practice in the context of COVID-19 can contribute to the ...

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Global regulators discuss observational studies of real world data for COVID-19 medicines

7 April 2020 - In a dedicated COVID-19 workshop, organised by the EMA under the umbrella of the International Coalition of ...

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