International regulators working together to enhance collaboration on COVID-19 observational research

8 February 2021 - In a dedicated COVID-19 workshop, convened under the umbrella of the International Coalition of Medicines Regulatory Authorities, ...

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Workshop on evaluating RWE from observational studies in regulatory decision-making

12 January 2021 - The FDA and the Duke-Margolis Center for Health Policy will hold a virtual workshop focused on ...

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STaRT-RWE: structured template for planning and reporting on the implementation of real world evidence studies

12 January 2021 - In alignment with the International Council of Harmonization’s strategic goals, a public private consortium has developed a ...

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ICER Analytics launched to accelerate the real world application of ICER reports, helping payers, the life science industry, and health care policy makers move from insight to action

30 November 2020 - The Institute for Clinical and Economic Review today formally launched ICER Analytics, a new cloud-based platform that ...

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Strengthening global collaboration on COVID-19 real-world evidence and observational studies

23 October 2020 - Medicines regulators from around the world discussed their experiences with supporting and assessing real-world evidence to facilitate ...

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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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