Weekly Round-ups
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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. Register to The Evidence Base to receive the round-ups of real-world evidence news and views direct to your inbox. |
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Round-up: 9 July 2026 How are life sciences organizations creating value from real-world data? Plus, second and third Joint Clinical Assessments published |
Round-up: 2 July 2026 The growing tension in rare disease coverage Plus, MFN one year on: Taking stock of US drug pricing reform |
Round-up: 25 June 2026 How to build real-world evidence that survives regulatory scrutiny Plus, two discontinued JCAs reveal emerging evidence standards as EU HTA assessments gather pace |
Archive – real-world evidence news and views:
June 2026
- 18 June 2026: An HEOR playbook for oncology RWE and AI use to support European HTA
- 11 June 2026: First EU Joint Clinical Assessment report published
- 4 June 2026: Comparing general-purpose and domain-specific AI in confounder identification for HTA submissions
May 2026
- 28 May 2026: How US drug pricing reforms are reshaping biopharma investment and innovation
- 21 May 2026: Insights and perspectives from ISPOR 2026
- 14 May 2026: Beyond clinical endpoints: HTA has a measurement problem
- 7 May 2026: EU HTA Regulation reaches operational milestone as first JCA endorsed
April 2026
- 30 April 2026: Assessing the return on investment of HEOR to the biopharmaceutical industry
- 23 April 2026: External control arms in oncology drug development
- 16 April 2026: Two visions for value – Why GCEA and HEMA clash on drug pricing
- 9 April 2026: Overcoming data and RWE challenges
- 2 April 2026: Industry perspectives on the first JCAs under EU HTA
March 2026
- 26 March 2026: Preparing orphan medicines for EU Joint Clinical Assessment
- 19 March 2026: How rare diseases are reshaping evidence generation, real-world data, and health policy
- 12 March 2026: Navigating the new era of global pricing interdependence
- 5 March 2026: Insights from the World EPA Congress
February 2026
- 26 February 2026: Best practices for EHR data curation in regulatory real-world evidence
- 19 February 2026: Do real-world data need to be “representative”?
- 12 February 2026: FDA outlines evolving framework for RWE and highlights RCT DUPLICATE demonstration project
- 5 February 2026: Understanding GLOBE and GUARD in most-favored-nation pricing
January 2026
- 29 January 2026: Uncovering unmet need: Using real-time RWD to close gaps in care and access
- 22 January 2026: Expert reflect on what changed and what’s next for RWE, drug pricing, and market access
- 15 January 2026: Patti Peeples speaks with Paul Scuffham
- 8 January 2026: FDA requests proposals to strengthen RWD methods supporting evidence generation and regulatory decisions
December 2025
- 18 December 2025: FDA finalizes guidance on using real-world evidence for medical device decisions
- 11 December 2025: What makes evidence matter? Examining the RWE decision paradox
- 4 December 2025: Rethinking global pricing strategies through the most-favored nation lens
November 2025
- 27 November 2025: Preparing effective systematic literature reviews and indirect treatment comparisons for JCA
- 20 November 2025: What ICH M14 means for global RWD safety studies
- 13 November 2025: The evolving role of evidence transportability
- 6 November 2025: Your guide to ISPOR Europe 2025
October 2025
- 30 October 2025: Turning data into evidence: fit-for-purpose RWD in practice
- 23 October 2025: Enabling equitable access to rare disease therapies through strategic evidence planning
- 16 October 2025: Coverage from the Duke-Margolis–FDA RWE Meeting
- 9 October 2025: Harnessing real-world data in Japan
- 2 October 2025: Insights from ISPOR RWE Summit and the GetReal Conference 2025
September 2025
- 25 September 2025: FDA catalogues examples of RWE use in regularity decision-making
- 18 September 2025: Strengthening vaccine confidence through real-world evidence
- 11 September 2025: JCA in Europe: Progress, challenges, and what’s next
- 4 September 2025: Towards standardized quality management for secondary data research
August 2025
- 28 August 2025: Lessons from long-term follow-up of gene and cell therapies in the EU
- 21 August 2025: The State of Real-World Evidence Policy 2025
- 14 August 2025: Rethinking comparators: how regulators are considering external controls for evidence generation
- 7 August 2025: EU HTAR conference insights
July 2025
- 31 July 2025: Building the blueprint for Patient-Centered Value Research
- 24 July 2025: Industry perspectives on the evolving regulatory landscape for pragmatic trials
- 17 July 2025: Toward a US HTA? Examining the IRA’s emerging role
- 10 July 2025: Personalizing race and ethnicity data to improve RWE relevance and reliability
- 3 July 2025: EMA reports significant growth in use of RWE for medicines regulation
June 2025
- 26 June 2025: FDA and NIH publish unified glossary to strengthen RWE research
- 19 June 2025: Addressing PICO challenges in the EU HTAR landscape
- 12 June 2025: Strategic evidence planning in the IRA: Insights from Year 1 drug price negotiations
- 5 June 2025: Using real-world data to track shifts in cancer screening and patient behavior
May 2025
- 29 May 2025: Real-world evidence generation in inflammatory bowel disease
- 22 May 2025: Open and closed claims: choosing the right data for the right insight
- 17 May 2025: Inside ISPOR 2025: Overview and key takeaways
- 8 May 2025: Implementing alternative payment models for innovative medicines
- 1 May 2025: Unintended consequences of the IRA on post-approval clinical trials
April 2025
- 24 April 2025: Charting health technology assessment reform – how HTA agencies are evolving their methods and processes
- 17 April 2025: Where credible science meets good policy: rethinking healthcare coverage and access in 2025
- 10 April 2025: HMA-EMA roadmap advances EU regulatory guidance on RWE
- 3 April 2025: Assessing the broader value of medicines: why does it matter and where do we go from here?
March 2025
- 27 March 2025: Characterizing a multinational EHR-derived RWD infrastructure for real-world oncology insights
- 20 March 2025: Bridging gaps in cancer care: tackling social drivers of health to improve access and outcomes
- 13 March 2025: Breaking barriers: addressing disparities in CAR T-cell therapy access
- 6 March 2025: EU greenlights European Health Data Space as stakeholders urge swift and effective implementation
February 2025
- 27 February 2025: Best practices to support electronic health record-sourced data quality
- 20 February 2025: Perspectives on the evolving use of generative AI in evidence generation and HTA
- 13 February 2025: Transforming and accelerating pharmaceutical research with blended data
- 6 February 2025: Hot off the press: our pick of articles within HTA and RWE published in January 2025
January 2025
- 30 January 2025: Unlocking the potential of Canadian health data
- 23 January 2025: Round two of Medicare price negotiations polarizes opinions
- 16 January 2025: Advancing the utilization of RWD in Japan’s pharmaceutical landscape through EHRs
- 9 January 2025: FDA updates on RWE for regulatory decision-making
December 2024
- 19 December 2024: Peering into the crystal ball: experts predict the future of RWE, HTA, and value-based healthcare in 2025
- 12 December 2024: AI for systematic literature reviews and evidence synthesis
- 6 December 2024: Beyond external control arms: Leveraging real-world data to support regulatory applications in oncology
November 2024
- 27 November 2024: Bridging privacy and research in real-world evidence
- 21 November 2024: ISPOR Europe 2024 daily round-ups and highlights
- 14 November 2024: Tailoring real-world data research with computable operational definitions
- 7 November 2024: EU HTA – Achieving broad access fast! What will it take for innovative medicines to succeed?
October 2024
- 31 October 2024: Understanding the use of transportability methods for real-world evidence generation
- 24 October 2024: ISPOR Real-World Evidence Summit 2024: event preview
- 10 October 2024: CMS guidelines finalize process for second cycle of the Medicare Drug Price Negotiation Program
- 3 October 2024: Digital health and RWE in pharmacoepidemiology: reflections from ISPE 2024
September 2024
- 26 September 2024: Digital health and RWE in pharmacoepidemiology: reflections from ISPE 2024
- 19 September 2024: FDA releases new guidance documents on real-world clinical trials
- 12 September 2024: Exploring the Nordic and UK real-world data ecosystems
- 5 September 2024: Navigating the maze of regulatory and health technology assessment agency real-world evidence frameworks
August 2024
- 29 August 2024: Coverage of the 2024 ISPE Annual Meeting
- 22 August 2024: Prices revealed for first 10 drugs subject to Medicare drug price negotiations but speculation continues
- 15 August 2024: Patient impact of the unintended consequences of the Inflation Reduction Act
- 8 August 2024: Debating the progress towards adopting RWE as part of the HTA regulation
- 1 August 2024: Progress in regulatory decision-making with RWE
July 2024
- 25 July 2024: FDA issues final guidance clarifying role of RWD from EHRs or medical claims in regulatory decision-making
- 18 July 2024: Broadening value assessment in the US: putting a price on health services and procedures
- 11 July 2024: Value Viewpoint – recent developments in US healthcare value and access with Kimberly Westrich
- 4 July 2024: FDA summarizes use of real-world evidence to support regulatory decision-making
June 2024
- 27 June 2024: ISPOR 2024 round-up
- 20 June 2024: Implementing targeted learning for causal inference using real-world data
- 13 June 2024: Balancing sustainability, innovation and patient access in the era of IRA and EU HTA
- 6 June 2024: ISPOR 2024 session deep dives
May 2024
- 30 May 2024: Long-awaited ICH M14 draft guideline on pharmacoepidemiologic studies utilizing RWD
- 23 May 2024: Setting the stage to shape the international harmonization of RWE standards
- 16 May 2024: Navigating the evolving role of real-world evidence in the Inflation Reduction Act
- 9 May 2024: ISPOR 2024 – daily round-ups and inside the plenaries
- 2 May 2024: Countdown to ISPOR 2024
April 2024
- 25 April 2024: EMA publishes new guidance on real-world evidence generation service
- 18 April 2024: Insights into ISPOR 2024: an interview with Rob Abbott, ISPOR
- 11 April 2024: Multistakeholder perspectives on preparing for EU HTA – ensuring stakeholder alignment to accelerate broad patient access
- 4 April 2024: ISPOR 2024: preview of the plenary sessions
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.