Resource Centre

RWE72 - Real World Evidence Driving Decision Making in Oncology

Real World Evidence: Driving Decision Making in Oncology

Oncology prescribing practices rely heavily on the data from clinical trials. However, due to lesser patient numbers found in clinical trials, knowledge gaps start presenting themselves in the form of understanding disease progression, overall survival, efficacy etc. Information like this can be collected in real world evidence studies so that more personalised treatment pathways can […]

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RWE71 - Real-world Evidence Allows for Customised and Precise Treatment

Real-world Evidence Allows for Customised and Precise Treatment

New data and technology can drive tailored treatments through physician education Real-world evidence shows comparative effectiveness, which is valuable when determining the ideal patient management scheme “A randomized clinical trial is trying to show efficacy. It asks, how well does this work under optimal circumstances? In contrast, a real-world evidence study is trying to show […]

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019 RWE Ideas Nov 2019

RCT Vs Real World Evidence

RCTs primarily generate efficacy; complement them with real-world evidence studies to generate effectiveness. Find out if a drug works in a real-life setting, with real patients. Determine when, how often and why a drug is used in a prescribing line. Retrospectively review patients for long periods of time. About SVMPharma SVMPharma is an innovative strategic […]

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018b RWE Ideas Oct 2019

150,000 patient RWE study initiated to evaluate Cologuard

Colorectal cancer, the second highest cancer killer in the US, can be detected by Cologuard; which has been shown to be 92% sensitive to colorectal cancer and 62% sensitive to high-risk pre-cancer patients. Cologuard is the only at-home colorectal cancer screening test approved by the FDA, and yet approximately 40% of the eligible patients aren’t […]

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RWE68 - Social Media Platforms a Direct-to-Patient RWD Route

Social Media Platforms: a Direct-to-Patient RWD Route

Patient focused care can only truly be supported with an empathetic perspective on patient experience. RWD  is typically utilised in reviewing clinical endpoints, however, it could be used for patient reported outcomes, and this is vital to a more holistic view of the disease area and its impact. Social media could be the gateway into […]

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RWE - 67 ISPOR on RWD Advantages

ISPOR on RWD Advantages

Rapid and effective data generation increases value for the study sponsor. Larger groups allow for longitudinally tracking of patient cohorts and sub-population analyses Real world studies demonstrate real-world practices and behaviours. SVMPharma, driving the outcomes that matter with RWE studies leading to positive HTA submissions and value based outcomes. Why be limited with small study populations, […]

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RWE66 NICE hints at the greater use of data analytics and real-world evidence

NICE hints at the greater use of ‘data analytics and real-world evidence’

A review on NICE’s HTA methodologies has been released, including review on quality of life measures NICE acknowledges the greater use of ‘data analytics and real-world evidence’ could play a part in how it might revise its methodologies. The aim is to support faster access to new technologies for patients Click here to read the source article […]

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018a RWE Ideas Oct 2019

Real-World Data Reveals Improved Durability Results Missed in IBD RCTs

Increased time-to-treatment-failure was revealed in a real world study on tofacitinib’s effectiveness The study allowed patients who wouldn’t have been considered for RCT inclusion to be analysed “This underscores the potential for real-world evidence studies to uncover new evidence of efficacy that might have been missed by the original controlled trials.” – Vivek Rudrapatna, University of California San Francisco […]

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Working Together is Essential to Release the Full Potential of Real World Evidence

Working Together is Essential to Release the Full Potential of Real World Evidence

Data can come from hospitals, patients, their family, government initiations, analytics companies, and a myriad of other potential partners For robustness, real-world data should come from several sources, allowing it to be translated into evidence to support other projects Coordinated co-operation is key to cover as many data sources as possible to fully utilise real-world […]

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RWE63 - RCT Snapshot vs. Real World Evidence treatment pathway

RCT snapshots vs. Real World Evidence treatment pathway

RWE can provide insight on an entire treatment pathway, whereas an RCT can typically only focus on a single line. This  evidence may be used to: aid in the refinement of patient care and clinical pathway design overcome data gaps inform clinical decision-making support RCT data in licensing and market authorisation applications Click here to find out more […]

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RWD Shows Treatment Effectiveness with 30,000 Patients

Swedish researchers investigated whether there were any clinically meaningful differences between anti-psychotic medications’ effectiveness in treating schizophrenia A RWD database was used to carry out the nationwide study RWE allowed the study to find the treatments most likely to prevent relapses Click here to see the source article    About SVMPharma SVMPharma is an innovative strategic consultancy, specialising in […]

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RWE61 - Oncology Electronic Prescribing Records Chart Note study

Oncology RWE – Electronic Prescribing Records Chart Note Study

RWE Oncology Electronic Prescribing Records provide a unique opportunity to conduct large scale chart note reviews within all NHS hospitals in the UK SVMPharma Oncology Electronic Prescribing Records Chart notes have studied more than 6,000 patients in multiple tumour sites (prostate cancer, renal cell carcinoma, ovarian cancer, and lung cancer) Oncology Electronic Prescribing Records provide […]

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Real World Evidence can define treatment information

RWE provides many useful insights, and is currently being used primarily for RCT evidence supplementation ” …it’s clear that real-world data will play an increasingly important role in how drugs are assessed in the future.”“Industry, academia and the public sector will all have to work together to make this a real priority.” – Dr Linda […]

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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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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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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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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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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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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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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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FINAL RWE38 ICE-PT

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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FINAL_RWE infographic 30

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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FINAL_RWE infographic 29

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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FINAL_RWE infographic 27

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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004_FINAL_RWE infographic 26

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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FINAL_RWE infographic 25

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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FINAL_RWE infographic 24

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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003_RWE 2 Infographic Layout-1

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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