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Posts tagged #RealWorldEvidence

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ジョンソン・エンド・ジョンソン、mCSPCでERLEADAがダロルタミド比で死亡リスク51%低減──24か月追跡のリアルワールド解析 | STELLANEWS.LIFE STELLANEWS.LIFE(ステラニュース・ライフ)は、科学や技術、医薬品分野における最新の研究成果や発見 | STELLANEWS.LIFE(ステラニュース・ライフ)は、科学や技術、医薬品分野における最新の研究成果や発見

Johnson & Johnson: ERLEADA Associated with 51% Lower Risk of Death Compared to Darolutamide in Real-World Analysis of Patients with mCSPC

stellanews.life/technology/8...

#ProstateCancer #ERLEADA #RealWorldEvidence #Oncology #JandJ #Apalutamide

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🚀 Join RADeep team at @vhir.bsky.social in Barcelona! 🚀

🔹 Data Engineer
👉 lnkd.in/d6Mkwg5q
🔹 Data Manager
👉 lnkd.in/dBsZrTXF

#Hiring #DataEngineer #DataManager #RealWorldEvidence #CareerOpportunity #RADeep #RADs

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Analysis of 346 BCBM cases from the GEICAM RegistEM registry reveals faster CNS progression and poorer survival in TNBC and HER2+ subtypes, with major differences between de novo vs subsequent brain metastases.
🔗 buff.ly/74yHwuH
#BreastCancer #BrainMets #HER2 #TNBC #RealWorldEvidence

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RWE Guidance Infographic and Updates

RWE Guidance Infographic and Updates

The regulatory landscape for #RealWorldEvidence has accelerated over the past decade, with new and updated guidance across regions and agencies. Without proactive planning, these can delay studies and increase costs and risks. Stay ahead: buff.ly/OPSIGsv

#RWE #PASS

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We're looking forward to the upcoming 2nd Annual EVIDENCE 360: RWE, Pricing & Market Access Summit. Will you be there? Connect with us on-site to discuss how RWE can add value across the product lifecycle. Email contact@lumanity.com

#EVIDENCE360 #RWE #MarketAcccess #RealWorldEvidence

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ECCO26 data reinforce long-term durability and real-world impact of AbbVie’s IBD portfolio Real-world data and three-year trial results show sustained remission and symptom control with Skyrizi and Rinvoq.

New data at ECCO 2026: Risankizumab & upadacitinib show sustained remission & real-world impact in UC & Crohn’s. Experts discuss 3-year durability, rapid symptom control & what it means for patients.
#News #ECCO26 #IBD #SKYRIZI #RINVOQ #RealWorldEvidence #AbbVie

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ECCO26 data reinforce long-term durability and real-world impact of AbbVie’s IBD portfolio Real-world data and three-year trial results show sustained remission and symptom control with Skyrizi and Rinvoq.

New data at ECCO 2026: Risankizumab & upadacitinib show sustained remission & real-world impact in UC & Crohn’s. Experts discuss 3-year durability, rapid symptom control & what it means for patients.
#News #ECCO26 #IBD #SKYRIZI #RINVOQ #RealWorldEvidence #AbbVie

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Download our infographic on how PASS is evolving and why staying aligned with these developments is critical

Download our infographic on how PASS is evolving and why staying aligned with these developments is critical

The regulatory landscape for #RealWorldEvidence has accelerated over the past decade. Proactive planning and staying aligned with these developments is crucial. Stay ahead of delays, increased costs, and misalignment risks: buff.ly/OPSIGsv

#RWE #PASS #RegulatoryGuidance

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The IMPACCT Real-World Evidence Summit Europe is here!

Meet with us to discuss how RWE can add value across the product lifecycle. Email contact@lumanity.com real-world-evidence-pharma-europe.com

#IMPACCTRWE #RWE #RealWorldEvidence

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Real‑world evidence in Ther Adv Med Onc shows nal‑IRI/5‑FU/LV significantly improves OS in pancreatic adenocarcinoma (28.0 vs 18.3 months) despite higher cost (ICER $33,285/LYG). 🔗https://buff.ly/dOq2XvY
#PancreaticCancer #GIOnc #RealWorldEvidence #HealthEconomics

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The world of clinical trials is evolving from rigid to "Pragmatic & Adaptive." ECT proves that past data can save future lives.

Have you ever worked with External Controls or Synthetic Arms? Let’s discuss below! 👇

#PeerOnSky #ClinicalTrials #ExternalControlledTrials #RealWorldEvidence

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UK moves ahead with GP patient data sharing plan The UK government has asked the NHS to start putting together the platforms to allow anonymised primary care patient data to be used by researchers.

#populationhealth #patientdatasharingplan #UKgovernment #NHS #populationbasedresearchprojects #GPhealthrecords #UKBiobank #OurFutureHealth #GenomicsEngland #100000GenomesProject #NHSGPdata #humanhealth #deidentifiedhealthdata #AMRC #healthinformation #realworldevidence #patientdata
zurl.co/rw8IC

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We're looking forward to the upcoming IMPACCT Real-World Evidence Summit Europe in a couple of weeks. Meet with us to discuss how RWE can add value across the product lifecycle. Email contact@lumanity.com real-world-evidence-pharma-europe.com

#IMPACCTRWE #RWE #RealWorldEvidence

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FDA outlines Advancing RWE pathway, reviews guidance and submission pitfalls At an FDA Grand Rounds, Dr. Marie Bradley described the Advancing Real World Evidence pathway (launched under PDUFA VII), guidance development, common reasons RWE submissions fail, and operational advice for sponsors seeking early consultation.

Dr. Marie Bradley reveals critical insights on the FDA's new Advancing Real World Evidence pathway, sharing essential guidance for sponsors to avoid common submission pitfalls.

Learn more here!

#US #CitizenPortal #RegulatorySubmissions #FDAGrandRounds #RealWorldEvidence #DataStandards

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Sieving for gold: external comparator studies to prioritize drugs for late-stage clinical trial External comparator (EC) studies can improve identification of compounds with the most promising performance in pre-pivotal single-arm trials (SAT). As SAT output lacks comparative insights, EC studie...

📢New article alert

New Perspective article on "Sieving for gold: external comparator studies to prioritize drugs for late-stage clinical trial"

🔗Read here: becarispublishing.com/doi/10.57264...

#OpenAccess #JCER #TrialMethodology #RealWorldEvidence #RWE

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Real‐World Effectiveness of Mepolizumab in Patients With Chronic Rhinosinusitis With Nasal Polyps: Findings From the European CRS Outcome Registry (CHRINOSOR) Background The SYNAPSE phase 3 study demonstrated that mepolizumab significantly improves nasal polyp score (NPS), quality of life and symptom severity in patients with chronic rhinosinusitis with n...

📣Thrilled to share our pan-European collaboration results: mepolizumab delivers progressive,real-world benefits in #CRSwNP! Nearly 50% achieved a deep composite response at 1 year, proving the power of staying the course.A huge team effort!
#biologics #RealWorldEvidence
🔗 dx.doi.org/10.1002/clt2...

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Becaris Publishing

ISPOR’s 2026–2027 Top HEOR Trends highlight the growing role of #AI, #RealWorldEvidence, and #ValueBasedHealthcare | Becaris Publishing becarispublishing.com/digital-cont...

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Expanding the evidence ecosystem: How PMR enriches Meta-Analysis and Real-World Evidence in Pharma Discover how PMR deepens meta-analyses and RWE by surfacing stakeholder perspectives and real-world context.

PMR enriches meta-analyses and strengthens RWE by surfacing stakeholder views, unmet needs & context beyond data. Case studies illustrate how PMR shapes design, reveals behaviors, and turns numbers into real-world insight.

medium.com/@vishalkrast...

#PrimaryMarketResearch #RealWorldEvidence

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Watch the full interview, download the infographic, and read the white paper on navigating evidence transportability in a global RWE landscape: buff.ly/ebw2AoN

#HTA #RealWorldEvidence #EvidenceTransportability #RWEStrategy #RWD

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Watch the full interview, download the infographic, and read the white paper on navigating evidence transportability in a global RWE landscape: buff.ly/ebw2AoN

#HTA #RealWorldEvidence #EvidenceTransportability #RWEStrategy #RWD

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Phases of Clinical Research Explained: Understanding   Phase I, II, III & IV Clinical Trials
Phases of Clinical Research Explained: Understanding Phase I, II, III & IV Clinical Trials Are you ready to understand how new medicines move from the lab to real patients? In this detailed tutorial, you’ll discover the phases of clinical research explained step-by-step — from the first-in-human studies to real-world post-marketing surveillance. Clinical research is at the heart of every medical breakthrough. Before a drug reaches patients, it passes through four critical phases of clinical trials, each designed to answer a specific question about safety, efficacy, and long-term performance. In this video, you’ll learn: ✅ Phase I: Is it safe? — How researchers test a new compound in humans for the first time. ✅ Phase II: Does it work in patients? — Proof of concept and dose-finding studies that measure early efficacy. ✅ Phase III: Is it better than what we have? — Large, global trials that provide the evidence needed for regulatory approval. ✅ Phase IV: What happens after approval? — Real-world data collection,...

This tutorial explains how real-world evidence, long-term safety data, and post-approval studies help identify new indications and improve patient outcomes.

Watch the full session here ➡️ youtu.be/qjkl9nY7djc

#PhaseIV #RealWorldEvidence #ClinicalResearch #SkyHealthAcademy

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Generating #RWE in #SpinalMuscularAtrophy (#SMA) faces hurdles with evolving standard of care, inconsistent outcomes measurement, severity baseline, and the need for long-term follow-up. Test your objectives with us: buff.ly/Qj6Z6Uq

#HCRU #SpinalCare #RealWorldEvidence

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Overcoming barriers to cell and gene therapy adoption with real-world evidence | Becaris Publishing

Overcoming barriers to #cellandgenetherapy adoption with #realworldevidence | @thermofishersci.bsky.social becarispublishing.com/digital-cont...

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Generating #RWE in #SpinalMuscularAtrophy (#SMA) faces hurdles with evolving standard of care, inconsistent outcomes measurement, severity baseline, and the need for long-term follow-up. Test your objectives with us: buff.ly/Qj6Z6Uq

#HCRU #SpinalCare #RealWorldEvidence

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SABCS25: Agendia’s genomic testing guides breast cancer care  Agendia’s VP of clinical development notes that new FLEX study data show genomic signatures predict chemotherapy benefit, improving personalized treatment for early breast cancer.

New data from Agendia's FLEX study at #SABCS2025 shows genomic signatures like MammaPrint can guide chemo choices & identify benefit in elderly patients.
#news #breastcancer #precisionmedicine #realworldevidence

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SABCS25: Agendia’s genomic testing guides breast cancer care  Agendia’s VP of clinical development notes that new FLEX study data show genomic signatures predict chemotherapy benefit, improving personalized treatment for early breast cancer.

New data from Agendia's FLEX study at #SABCS2025 shows genomic signatures like MammaPrint can guide chemo choices & identify benefit in elderly patients.
#news #breastcancer #precisionmedicine #realworldevidence

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What makes evidence matter? Examining the real-world evidence decision paradox | Becaris Publishing

What makes evidence matter? Examining the #realworldevidence decision paradox | becarispublishing.com/digital-cont...

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Overcoming barriers to cell and gene therapy adoption with real-world evidence | Becaris Publishing

Overcoming barriers to cell and gene therapy adoption with #realworldevidence | @thermofishersci.bsky.social becarispublishing.com/digital-cont...

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