In the era of cell and gene therapy, how robust is RWE collection?

  “Data collection infrastructure for patient outcomes in the UK – opportunities and challenges for cell and gene therapies launching” “Existing data collection infrastructure in indications with potential cell or gene therapies launches in the next five years in the UK is overall not sufficient to facilitate outcomes-based reimbursement.” Click here to see the source article  Reference Jørgensen, J., […]

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RWE improving asthma outcomes

5.4 million people in the UK are currently affected by asthma 3 three year projects will be taking place in Manchester, Edinburgh and Portsmouth respectively Each project set to receive more than £200,000 from innovate and Asthma UK Click here to see the source article  Reference GOV.UK. (2019). Better, faster, more personalised asthma treatment. [online] Available at: [Accessed 28 […]

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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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