Real World Data
Optimising the use of real world data to drive effective outcomes
Real world evidence (RWE) continues to drive healthcare and research discussions and decisions. ICON delivers Real World Intelligence®, bringing together innovative thinking and technology solutions to identify, generate, and communicate the clinical, safety and cost-effectiveness evidence that regulators, payers and providers demand.
Generate RWE using cross sectional studies and medical chart reviews
Download our white paper, Real World Evidence Generation: The Value of Cross-Sectional Studies and Medical Chart Reviews to learn how this hybrid approach to study design can be advantageous for generating real world evidence. Get insights on the issues you need to consider to ensure that your study is planned to produce robust scientific data that can be extrapolated beyond the study population.
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Media article: How can real world data improve clinical trial outcomes?
Kathleen Mandziuk, VP of Real-World Solutions, offers her insights on the use of real world data to improve clinical trials outcomes.
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Media article: Injecting real-world data into every day clinical trials
Kathleen Mandziuk, VP Real World Solutions, offers insights into the importance of real-world data in clinical trials and how it can be used to inform trial recruitment.
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Media article: Evolution of clinical trial data calls for evolved response
Emily Mitchell and Kathleen Mandziuk discuss how study data has progressed in recent years and how trial teams can keep up effectively with proper data management.
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Blog: Generating RWE to maximise revenue in biotech trials
As more biotech companies use RWE to support approvals, broader real-world outcomes for their products will emerge.
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Blog: Real World Evidence: The evolving views of regulators and payers
Study designs and real-world data sources are evolving to meet drug development needs.
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Blog: RWE and the clinical research landscape
The increasing availability of big data is creating a shift in the clinical research landscape, allowing researchers to make intelligent, strategic decisions based on real world evidence that is derived from the aggregation and analysis of real world data.
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Blog: Real World Evidence generated through hybrid studies
Cross-sectional surveys (CSS) and medical chart reviews (MCRs) are both common study designs, and each has its strengths and limitations.
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Blog: Five common barriers to harmonised real world data (RWD)
Duplicate data environments, redundant data subscriptions, and siloed data access are not providing a good enough return on investment for Real World Evidence (RWE) generation.
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Blog: Reduce the cost of post-market surveillance with Real-World Data
As with every aspect of clinical research, the cost of post-market surveillance and other post approval studies is rising fast – and in some cases, exceeds projected revenues.
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Blog: Smart ways to collect Real-World Data for device trials
Based on clinical data alone, manufacturers can only speculate on a device’s cost-savings in the real world.
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Blog: On Formulary Fast: accelerating the access and reimbursement process
A new rate-limiting step has emerged in drug and device development.
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Blog: Innovation in real world data collection
The industry, intelligent data, meaning data that can be leveraged to make more informed decisions, and early planning for payer evidence generation, are integral to the solution.
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Blog: 10 lessons learned about secondary “real world” data strategy
Insights and lessons learned about operationalising the use of real world data.
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Media article: 21st Century cures act: expanding use of real-world evidence (RWE)
Expert insights on the 21st Century Cures Act's relation to the expanding use of real-world evidence (RWE).
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Media article: Applying RWE to rare disease drug development
Real-world data studies play a key role in orphan and rare disease research.
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Media article: RWE continues to shape the future clinical research landscape
A discussion on how sponsors can take advantage of technology innovations to collect, standardise and analyse real world data for more informed, strategic regulatory and reimbursement decisions.
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Blog: Tackling RWE challenges to demonstrate healthcare value
Real world evidence (RWE) is expected to have a significant impact on how healthcare technologies and biopharmaceuticals will be developed and consumed.
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Blog: Towards a data-driven feasibility assessment
A data-driven feasibility assessment can help ensure that your clinical research plan is designed to enroll the right patients, rely on the right investigators, and take place in the right countries for success.
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Media article: Encouraging patient participation in real world studies
Real world data is rapidly becoming the latest frontier for life sciences companies for supporting regulatory filings and conducting drug safety surveillance.
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Media article: Mind the gap: managed access programmes as an alternative to long-term follow up studies
Veronica Guiterrez Martinez and Michael Tokar at ICON discuss the challenges of setting up MAPs and the various considerations that must be tackled for a successful programme.
Real World Data webinars
The landscape of real world data can be difficult to navigate
Database mapping provides a tool to systematically identify and evaluate RWD sources.
Effective ingestion and normalization of real world data sources
As more sources of anonymized Real World Data (RWD) become available, the ability to ingest, standardize and then link the collected disparate data sets is critical to creating insightful, analytical output.
Five common barriers to harmonised real world data (RWD)
Duplicate data environments, redundant data subscriptions, and siloed data access are not providing a good enough return on investment for Real World Evidence (RWE) generation
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Optimise your RWE investments
Increasing drug development cost, the shift from volume to value-based pricing, and competition from generics and biosimilars, are forcing pharma and life science organizations are looking towards Real World Evidence (RWE) to prove the value – cost, safety, and effectiveness - of their products.
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How RWE continues to shape the late phase research landscape
Creating a comprehensive RWE strategy demands a focus on organizing and synthesizing the many real world data (RWD) asset options that are available to life sciences companies.
Real world evidence across the product lifecycle
Payment models and federal reforms are increasingly focused on the real world impact of treatments and devices. More regulatory guidance is being released in both the US and EU around the use of RWE to support and enhance submissions and product uptake.
Reduce the cost of post-market surveillance with real world data
Real-World Evidence (RWE) is derived from Real World Data (RWD), and early use of Real World Evidence can cut post-marketing study costs and Medical Device time-to-market.
Devices are especially good candidates for early RWE use since evidence collected in the context of actual patient care from previously approved versions or similar devices often can be used to supplement findings from clinical trials of the latest version in development.
RWD and Alzheimer's disease
Real world data such as sleep quality and quantity have clinical relevance in Alzheimer's disease, providing objective measures of sleep and activity patterns that are not subject to patient recall bias. Review the use of wearables in Alzheimer’s disease to provide objective measures of sleep and activity patterns that are not subject to patient recall bias.
Harnessing technology to maximise RWE value
Late phase research is undergoing rapid transformation due to the impact of healthcare digitalisation and the greater availability of and access to Real World Data (RWD).
Meeting evidentiary needs with EHRs
How can the abundance of Real World Data (RWD) from Electronic Health Records (EHRs) enhance your late phase research studies while decreasing study costs?
Receive more insights on Real World Data
Please visit ICON's Preference Centre and select 'Real World Evidence' under 'Topics of Interest' to receive new insights on oncology.