RCT outcomes predicted by RWE

FDA and Brigham and Women’s Hospital have expanded their previous RCT DUPLICATE demonstration project to predict the results of seven Phase IV trails that are currently ongoing Part of the project will estimate the results of randomised controlled trials before they are finished with the use of RWE Click here to see the source article  Reference Hale, C. (2019). Using […]

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RWE can accelerate the pace of discovery of new oncology therapies

Companies and HTA bodies are looking at real-world evidence to inform reimbursement of novel cancer therapies like CAR-T Click here to see the source article  Reference Be The Match BioTherapies. (2019). CIBMTR to Track Long-Term Outcomes Data for Kymriah®. [online] Available at: [Accessed 23 Apr. 2019].   About SVMPharma SVMPharma is an innovative strategic consultancy, specialising in Real World […]

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RWE Challenges and Misconceptions

A look into the 5 common myths for the adaption of patient-reported RWE for devices, these include Age as a barrier to technology HCP reluctance to adopting new technology Sharing of health data Clinical trial compliance The readiness of device platforms Click here to see the source article  Reference Hellman B. Real-World-Evidence Mythbusting: 5 myths holding back patient-reported RWE […]

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Digitalisation of health records leveraging RWE

“It’s getting more expensive to do traditional clinical trial research, so industry is looking at ways it can achieve similar goals using routinely collected data,” said Paul Taylor, a health informatics expert at University College London. “As the breadth and reliability of RWE increases, so do opportunities for FDA to also make use of this […]

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European regulators are looking at RWE for HTA

Two ongoing Horizon 2020 projects, COMED and IMPACT-HTA, will provide methodological guidance on how to use RWD for health economic evaluation, where COMED will be focusing more on medical devices and IMPACT-HTA on economic evaluation in the context of HTA Click here to see the source material Reference (2019). Home. [online] Available at: [Accessed 5 Mar. 2019]. […]

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50% of real-world studies started in the last 3 years

Half of the world’s 1,800 clinical studies involving real-world or real-life data since 2006 have been started in the last three years (from 2015-2018), according to a Reuters analysis of the U.S. National Institutes of Health’s website Studying real-world evidence offers manufacturers a powerful tool to prove the value of their drug Hot areas […]

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002 FINAL SVMPharma RWE highlight infographic 03-01-2019

RWE roundup – December 2018

FDA FDA releases new strategic framework for assessing the potential use of RWE in connection with drug review program Click here to find out more   ASH Researchers identify nutation in BCL2 protein that causes resistance to venetoclax in progressive CLL Click here to find out more   NICE NICE recommends MSD’s Keytruda within the CDF […]

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Unique real-world study in diabetic macular oedema (DMO)

SVMPharma has recently collected real-world data in the UK (ICE-UK) and Portugal (ICE-PT) for DMO patients looking at the effectiveness of fluocinolone acetonide intravitreal implant (LUVIEN®). This has led to successful outcomes leading to multiple publications to presentations in a major European congress in 2017 and 2018 Chart notes Treatment data Align with KOLs SVMPharma’s […]

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FINAL RWE39 DESERVE infographic

DESERVE showed significant benefits in NHS healthcare savings

SVMPharma’s real-world evidence helped deliver a real-world study looking at the clinical outcomes of triptorelin vs other LHRH agonists (LHRHa) in clinical practice for prostate cancer patients. Our real-world evidence helped show a significant reduction in healthcare resource utilisation for the NHS as well as maintenance in PSA control (a biomarker in prostate cancer) when switching to a 6-monthly formulation […]

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