Weekly Round-ups
Each week, The Evidence Base circulates a Weekly Round-up covering real-world evidence news and views to members summarizing what we’ve been up to over the past week. To browse past round-ups see below.
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Round-up: 25 April 2024 EMA publishes new guidance on real-world evidence generation service Plus, ISPOR 2024: Navigating the conference program |
Round-up: 18 April 2024 Insights into ISPOR 2024: an interview with Rob Abbott, ISPOR Plus, impact of the Inflation Reduction Act on real-world evidence: an interview with Amanda Cole, Office of Health Economics |
Round-up: 11 April 2024 Multistakeholder perspectives on preparing for EU HTA – ensuring stakeholder alignment to accelerate broad patient access Plus, new report emphasizes need for clear guidance to enhance EU Joint Clinical Assessment for cancer treatments |
Archive – real-world evidence news and views:
April 2024
March 2024
- 28 March 2024: Supporting drug reimbursement decision-making in Asia with RWD and RWE: the REALISE framework
- 21 March 2024: FDA advances RWE in regulatory decision-making with new draft guidance on non-interventional studies
- 14 March 2024: Insights from the World EPA Congress 2024
- 7 March 2024: EMA update on DARWIN EU exploring RWE to support regulatory decision-making
February 2024
- 29 February 2024: Understanding the human impact of rare diseases with Jean-Christophe Novelli
- 22 February 2024: ISPOR 2024: First look at the conference program
- 15 February 2024: The end for QALYs in federal US drug value assessments?
- 8 February 2024: Towards a more efficient use of registry-based real-world data in Europe
- 1 February 2024: What’s in a name? Towards standardizing the terminology of real-world data and real-world evidence
January 2024
- 25 January 2024: The year in review: a look at the top developments in RWE and HTA in 2023
- 18 January 2024: IVI-MDD Value Model: Advancing health economic modeling of depression
- 11 January 2024: FDA guidance on registries, RWD and digital health technologies
- 4 January 2024: RWE in regulatory decision-making for medical devices
December 2023
- 28 December 2023: The year in review: a look back on The Evidence Base
- 21 December 2023: FDA seeks to clarify use of RWE in regulatory decision-making for medical devices
- 14 December 2023: Multi-stakeholder perspectives on the evolution of RWD
- 7 December 2023: FDA’s RWE demonstration projects
November 2023
- 30 November 2023: Towards the European Health Data Space (TEHDAS)
- 23 November 2023: ICER value assessment framework for digital health technologies
- 16 November 2023: ISPOR Europe 2023 Special
- 9 November 2023: Duke-Margolis white paper on real-world evidence master protocols
- 2 November 2023: ISPOR Europe 2023 – Editor’s picks of the sessions to attend
October 2023
- 26 October 2023: NICE’s RWE framework in action
- 19 October 2023: DIA RWE 2023: The year that’s been, and a look at what’s to come for RWE
- 12 October 2023: Duke-Margolis white paper on improving patient subgroup representation with RWD
- 5 October 2023: Peter Neumann discusses RWE, QALYs and HT
September 2023
- 28 September 2023: ICER revises its value assessment framework, but is it enough?
- 21 September 2023: Harmonizing health technology assessment in Europe
- 14 September 2023: Mark McClellan discusses the Inflation Reduction Act
- 7 September 2023: First Drugs Selected For Medicare Drug Pricing Negotiation
August 2023
- 31 August 2023: FDA final guidance on use of RWD and RWE to support regulatory decision-making
- 24 August 2023: Impact of the Inflation Reduction Act on real-world evidence
- 17 August 2023: Case studies of FDA recently approved product applications using RWE
- 10 August 2023: Rounding up our most-read content from 2023 so far
- 3 August 2023: 1st GetReal Institute Annual Conference Breakouts: EHDEN, Trials@Home and DARWIN EU
July 2023
- 27 July 2023: New report by the Office of Health Economics on best practices for RWE
- 20 July 2023: RWE and HTA – a snapshot of recent developments with Sreeram Ramagopalan
- 13 July 2023: The IRA in numbers: HHS predicts savings for >18 million people in 2025
- 6 July 2023: CMS revisions to Medicare Drug Price Negotiation Program, and initial reactions
June 2023
- 29 June 2023: The Inflation Reduction Act in numbers: impact on small molecule medicine development
- 22 June 2023: Mark McClellan discusses real-world data and evidence in global contexts
- 15 June 2023: Assessing the dissemination of RWE publications for clinical decision making
- 8 June 2023: CMS to make new Alzheimer’s disease drugs available with RWD collection caveat
- 2 June 2023: Emerging role of US healthcare data in global HTA
May 2023
- 25 May 2023: Impact of the Inflation Reduction Act on US health care
- 18 May 2023: CADTH joint final guidance on reporting real-world evidence studies in Canada
- 12 May 2023: Key takeways from ISPOR 2023
- 5 May 2023: Navigating ISPOR 2023
April 2023
- 28 Apr 2023: Insights from RCT-DUPLICATE
- 20 Apr 2023: ICER white paper recommends HTA strategies to improve health equity
- 13 Apr 2023: Towards the next generation of decentralized trials
- 6 Apr 2023: First DARWIN EU real-world evidence studies conducted
March 2023
- 30 Mar 2023: Fostering a connected health data community in Europe through EHDEN
- 23 Mar 2023: Deep dive into the 1st GetReal Institute Annual Conference: Multi-stakeholder reflection of the global landscape of RWE
- 16 Mar 2023: What next for QALYs in US drug value assessments? If approved by Congress, new legislation in the US could lead to a ban on federal agencies using QALYs in drug value assessments
- 9 Mar 2023: Role of patients in the generation and communication of real-world studies: an interview with Catherine Bottomley, Vitaccess
- 2 Mar 2023: Understanding the value assessment landscape in the United States: an interview with Emily Ortman, PhRMA Foundation
February 2023
- 23 Feb 2023: Evaluating the role of single-arm trials in oncology decision-making: an interview with Sorrel Wolowacz, RTI Health Solutions
- 16 Feb 2023: Two years of the GetReal Institute: an interview with Shahid Hanif.
- 9 Feb 2023: Read our interview with Kraig Kinchen, Eli Lilly about RWE generation from point-of-care trials.
- 2 Feb 2023: In this interview, we speak with Craig Lipset about two years of the Decentralized Trials and Research Alliance.
January 2023
- 26 Jan 2023: Read about recent articles published in the Journal of Comparative Effectiveness Research.
- 19 Jan 2023: What R WE reading in the Journal of Comparative Effectiveness Research?
- 12 Jan 2023: Take a look back on the most significant events from across the globe that took place in 2022 and are shaping the field of RWE for 2023 and beyond.
- 5 Jan 2023: The Evidence Base, in association the PCSIG, is running a panel discussion on 1st March 2023.
December 2022
- 21 Dec 2022: In this case study, discover IQVIA’s approach to identifying patients who are classed as ‘hard-to-find’.
- 13 Dec 2022: Our latest article from Sreeram Ramagopalan, where he discusses recent developments regarding RWE in the context of HTA.
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