Elizabeth Merrall
@ElmStatistics
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Statistician working in pharma development and interested in all things stats-related, esp real world data applications.
Joined January 2021
- Insights from @LevonDemi a structured approach to assess #RWD providers as a sponsor. - Jeff Abolafia will share his thoughts as an experienced regulatory reviewer of submissions including #RWD.
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@LevonDemi @JNJNews @Certara @PHUSE_Global As is customary, we will make sure to have time for some lively discussion, where both speakers will be ready to answer your questions!
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#NextTUESDAY Getting the RWD that we need - From Both Sponsor and Regulator Perspectives Join us for our last community forum for the year: https://t.co/E5c9eQia1T
@LevonDemi @JNJNews @Certara @PHUSE_Global
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@ArrivaKent Now the short trips are being penalized. Given a choice of paying for 2 adults and 2 kids to travel from Wheatsheaf pub (Loose Road, Maidstone) to Old Loose Hill, it was a financial no-brainer to take the car instead.
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Earlier today the government announced a cut to the UK aid budget to fund an increase in defence spending. 12 years ago, we released this video to show how aid protects children in the toughest situations. Now, the message is more important than ever.
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Wistfully remembering a different time/administration....... recording and slides for this workshop can be found here.
healthpolicy.duke.edu
Meeting Objective: To provide an update, as well as to solicit input from interested parties, on current and future activities of the U.S. Food and Drug Administration (FDA)'s Real-World Evidence...
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Help save the £2 bus cap by signing my petition on the Government site please? It only takes a couple of minutes to send a message to Labour. Thank you. #savethe£2cap #affordablebustravel
https://t.co/AfpWJtkh4k
petition.parliament.uk
People are struggling to make ends meet and the £2 bus ticket cap has been a lifeline to many, particularly in rural communities.
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HNY! 2 Jan 2025 and I'm already missing the £2 bus fare cap @ArrivaKent charged me £5.60 for 2 adults for a few stops on the 85 from Mote Park into Maidstone, enough that I could be persuaded to switch to the car..... needless to say we skipped the bus back and walked instead!
"If we hadn't taken the action, the fare cap would have been lifted entirely" Transport Secretary Louise Haigh defends raising the £2 bus fare cap to £3, and says the £2 cap ending on 31 December "was the funding settlement I inherited" #BBCLauraK
https://t.co/zQx2szLVjo
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PHUSE has exciting news to announce…we are launching a BRAND NEW Working Group event in 2025 – the Real World Data Spring Event! This exciting event, taking place virtually from 9–10 April, will connect the PHUSE Community in exploring how real world data (RWD) is shaping the
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One to put in the calendar!! RWD for Regulatory Decision-Making: Learnings from Use Cases and Demonstration Projects Our next @PHUSETwitta community forum with @backerman150 from JnJ and Ulka Campbell from @aetioninc: https://t.co/SKyXmNjy6V
#rwd #regulatory
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Leading Integrity Could the conviction of Lucy Letby be one of the worst cases of scapegoating, or whistleblower retaliation in UK history? Are we seeing yet another Birmingham 6, Guilford 4, Post Office 900, or... (the list is long)?
telegraph.co.uk
Neonatal ward manager lists why nurse, who would eventually be convicted of murder, could not be behind the deaths of babies
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Public hybrid workshop hosted by @US_FDA and @DukeMargolis: Optimizing the Use of RWE in Regulatory Decision-Making for Drugs and Biological Products. https://t.co/4L5nH7yROX
#WorthToShare #RWE #RWD #FDA
fda.gov
This public workshop will discuss potential next steps to promote the continued evolution and consistent application of real-world data in drug development.
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🎺Roll up! Roll up! 🎺Our upcoming #RWD @PHUSETwitta community forum: #RWD Sources – How the Genesis of Your Data Determines What Questions You Can Answer. 24 October at 14:00-15:00 (BST) / 9:00-10:00 (EDT) More details and registration are here:
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🎺Roll up! Roll up! 🎺Our upcoming #RWD @PHUSETwitta community forum: #RWD Sources – How the Genesis of Your Data Determines What Questions You Can Answer. 24 October at 14:00-15:00 (BST) / 9:00-10:00 (EDT) More details and registration are here:
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Because "robust RWE is not only beneficial to health authorities... robust evidence is critical across ALL types of healthcare decisions" https://t.co/HiIhQzBaLF
#rwd #rwd
ispor.org
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"Strict standards still apply" - another insightful collaboration with @PHUSETwitta and @JNJInnovMed colleagues alike - exploring challenges in the application of @US_FDA's Guidance on Assessing Registry Data:
phuse.global
PHUSE — The Global Healthcare Data Science Community
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“It would be expensive, but not nearly as expensive as getting the science and statistics wrong.”
I have been interviewed about the Letby case for @PrivateEyeNews podcast, available later today. I think the law would be greatly improved if 1. Complex medical and statistical evidence was sent for expert peer review by the CPS prior to the trial, for a thorough and balanced
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"acceptability of RWE also critically depends on whether the characteristics of the clinical development program align with circumstances in which the FDA may have flexibility in considering evidence from RWD study designs vs more robust designs" #RWE #FDA
https://t.co/OIOEhuAKa8
pubmed.ncbi.nlm.nih.gov
Based on recent guidance and publicly available approvals, the US Food and Drug Administration (FDA) has demonstrated its openness to considering evidence of effectiveness from real-world data (RWD)...
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#LucyLetby “This could not have been a coincidence!” I've always had my doubts about this case and am pleased to see the @RoyalStatSoc drawing attention to the potential misunderstandings of stat evidence in court. Section 2 of the 2022 report is particularly relevant.
We’re aware of concerns raised by some RSS members and the wider statistical community around the statistical aspects of the Lucy Letby case Read our full statement: https://t.co/OurkJGZaQ2
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