Resource Centre

RWE59 - Do RWE results match those from RCTs

Do RWE results match those from RCTs?

A pilot study led by Friends of Cancer Research (Friends) investigated how real world evidence (RWE) compares to the results from randomised clinical trials (RCTs) (for advanced non-small cell lung cancer). The study showed consistency between RWE and RCTs, emphasising their potential for supporting clinical decision-making “RWE is an important tool for continued learning about treatment outcomes […]

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RWE58-Real World Evidence shows impact of HPV vaccines on cervical cancer

Real World Evidence shows impact of HPV vaccines on cervical cancer

A systematic review and meta-analysis has shown strong evidence of the effectiveness of the HPV vaccine “Our results can be used by clinicians to illustrate the real-world impact of HPV vaccination outside the very controlled settings of randomized trials.” – Marc Brisson, PhD (Université Laval, Quebec, Canada) “…it was interesting that the promising HPV vaccine efficacy […]

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RWE57 - FDA’s INFORMED science and technology incubator, to bring real world data to the development of breast cancer treatment

FDA’s INFORMED science and technology incubator, to bring real world data to the development of breast cancer treatment

In 332,630 new cases of breast cancer, only 3% – 5% of patients participated in traditional clinical studies. RWE: “expected to allow for deeper insights and greater understanding of the variance of patient treatment outcomes” An initial two year contract focused on breast cancer, but there’s potential to explore other cancer epidemiology Click here to see the source article    About SVMPharma […]

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RWE56 - Why sample size matters

Why sample size matters

1000 patient record study with Cancer Electronic Prescribing Records (EPRs), the data source for SACT. RWE to be used in improving patient care. Click here to see the source article    About SVMPharma SVMPharma is an innovative strategic consultancy, specialising in Real World Evidence (RWE) for the pharmaceutical industry. SVMPharma generates RWE within UK and Europe through bespoke online […]

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RWE55 - FDA encourages RWE in oncology

FDA encourages RWE in oncology

RWE can provide deep and accurate real-world clinical evidence, providing useful data for the increasingly stratified molecular subtypes of cancer “When we enable oncologists to see patient data clearly, we can make sure that everyone touched by cancer finds the right path to the right care.” Click here to see the source article    About SVMPharma SVMPharma is an […]

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RWE54 - RWE highlights treatment gaps in Major Depressive Disorder patients

RWE highlights treatment gaps in Major Depressive Disorder patients

“Data Presented at the American Psychiatric Association 2019 Meeting Suggest a Low Rate of Psychiatric Care Received by Adult Patients with MDD Before Suicide Ideation or Attempt Diagnosis” “Additional Data Show Patients Have a High Risk of Hospital Readmission or Subsequent Emergency Department Visit after Suicide Ideation or Attempt” Click here to see the source article  About SVMPharma SVMPharma […]

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RWE53

Leveraging RWD to improve regulatory decisions

How real world evidence was used to support approval of Ibrance for male breast cancer “Leveraging RWD to improve regulatory decisions is a key strategic priority for the FDA. This data may be derived from a variety of sources, such as electronic health records, medical claims, product and disease registries, laboratory test results and even […]

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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: https://www.gov.uk/government/news/better-faster-more-personalised-asthma-treatment [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: https://bethematchbiotherapies.com/newsroom/cibmtr-to-track-long-term-outcomes-data-for-kymriah/ [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 Comedh2020.eu. (2019). Home. [online] Available at: http://www.comedh2020.eu/wps/wcm/connect/Site/COMED/Home [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 clinicaltrials.gov website Studying real-world evidence offers manufacturers a powerful tool to prove the value of their drug Hot areas […]

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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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A retrospective cohort study of the clinical outcomes of ILUVIEN in four ophthalmology centres in Portugal (ICEPT)

SVMPharma’s real-world evidence helped deliver a unique real-world multicentre study in Portugal (ICEPT) looking at the clinical outcomes of fluocinolone acetonide implant (ILUVIEN®) in clinical practice for diabetic macular oedema (DMO) patients. Our real-world evidence provided valuable insights and helped show a marked reduction in odema in 66% of DMO patients’ eyes (n=75) in real-world clinical practice.   A retrospective cohort study […]

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FINAL RWE36 ICE infographic

SVMPharma’s real-world studies in diabetic eye oedema led to multiple successful publications and congress presentations in the UK and Europe

SVMPharma has recently collected real-world data in the UK and Europe for which has lead to successful outcomes from publications to presentations in a major European congress Click on the references below to find out more References (1) Currie CJ. Patterns of retinal thickness prior to and following treatment with fluocinolone acetonide 190 µg intravitreal implant for diabetic macular […]

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FINAL RWE37 CF infographic

First real-world multicentre study of the use of inhaled aztreonam lysine in clinical practice

SVMPharma’s Real World Treatment Evaluator tool helped deliver the first real-world multicentre study of the use of inhaled aztreonam lysine in clinical practice for cystic fibrosis (CF) patients. Our treatment evaluator tool provided valuable insights and demonstrated significant improvement in lung function in CF patients in a real-world setting.   A treatment evaluator tool to monitor the […]

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Answering real world clinical questions with Real World Data

Click here or the image below to find out more Keywords: Real World Evidence, Real World Data, Retrospective, Prospective, Rapid outcomes, Clinical outcomes, Clinical Insights, Health Technology Assessment, The National Institute for Health and Care Excellence, NICE, Data Gaps, Post-Approval  

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97% of Companies to Increase Use of Real World Patient Data

Click here or the image below to find out more Keywords: Real World Evidence, Real World Data, Retrospective, Prospective, Rapid outcomes, Clinical outcomes, Clinical Insights, Health Technology Assessment, The National Institute for Health and Care Excellence, NICE, Data Gaps, Post-Approval  

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Who are the Real World Evidence Stakeholders?

Click here or the image below to find out more Keywords: Real World Evidence, Real World Data, Retrospective, Prospective, Rapid outcomes, Clinical outcomes, Clinical Insights, Health Technology Assessment, The National Institute for Health and Care Excellence, NICE, Data Gaps, Post-Approval  

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NICE leads access to medical devices

Click here or the image below to find out more   Keywords:  Medical Device, FDA, Real World Evidence, Real World Data, Retrospective, Prospective, Rapid outcomes, Clinical outcomes, Clinical Insights, Health technology assessment, The National Institute for Health and Care Excellence, NICE, Data Gaps, Post-Approval

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Turning Real World Data into Real World Evidence: identifying and overcoming RCT data gaps

Click here or the image below to find out more   Keywords:  SACT, Systemic Anti-Cancer Therapy, Oncology, Electronic Prescribing Records, Real World Evidence, Real World Data, Retrospective, Prospective, Overall Survival, Progression Free Survival, Response rates, Rapid outcomes, Treatment pathways, Clinical outcomes, Line of therapy and cycles, Clinical Insights, Health technology assessment, The National Institute for Health and Care Excellence, NICE, RCT, Registration Studies, Data […]

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RWD and RWE: Where is the Value?

Click here or the image below to find out more Keywords:  SACT, Systemic Anti-Cancer Therapy, Oncology, Electronic Prescribing Records, Real World Evidence, Real World Data, Retrospective, Prospective, Overall Survival, Progression Free Survival, Response rates, Rapid outcomes, Treatment pathways, Clinical outcomes, Line of therapy and cycles, Clinical Insights, Health technology assessment, The National Institute for Health and Care Excellence, NICE, Resource implications, Payer communication

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30% oncology NICE submissions not recommended

Click here or the image below to find out more Keywords:  SACT, Systemic Anti-Cancer Therapy, Oncology, Electronic Prescribing Records, Real World Evidence, Real World Data, Retrospective, Prospective, Overall Survival, Progression Free Survival, Response rates, Rapid outcomes, Treatment pathways, Clinical outcomes, Line of therapy and cycles, Clinical Insights, Health technology assessment, The National Institute for Health and Care Excellence, NICE

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FINAL_SVMPharma oncology electronic prescribing_reviewed 18-09-2017

SACT vs. Oncology Electronic Prescribing Records

Click here or the image below to find out more Keywords:  SACT, Systemic Anti-Cancer Therapy, Oncology, Electronic Prescribing Records, Real World Evidence, Real World Data, Retrospective, Prospective, Overall Survival, Progression Free Survival, Response rates, Rapid outcomes, Treatment pathways, Clinical outcomes, Line of therapy and cycles, Clinical Insights

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eyeforpharma EU Summit 2016: RWE survey results

75% of industry professionals polled at the efp EU Summit 2016 said internal and external barriers were among the top reasons stopping them from doing RWE projects. Find out more in our survey results below For more on the eyeforpharma EU Summit and RWE, see our presentation by clicking here    

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