Unlocking the Potential of Real World Evidence for Oncology With Simulated Data
Adam Reich, Principal, Real World Solutions
Sep 30, 2019

A revolutionary period of cancer research

We are amid a revolutionary period of cancer research, marked by new advances in cancer therapy, an increasing focus on personalised treatment, growing availability of immunotherapies, and emerging technologies. These trends have important implications for future drug development, and innovative therapies will require new insights and evidence sources to demonstrate their value.

But how do we efficiently access these evidence sources as governance and privacy concerns increase?

England’s cancer registry data has potential to bolster global research

Public Health England (PHE) collects and maintains one of the largest and most detailed population-level cancer databases in the world, the Cancer Analysis System (CAS). The data contains information about patient and tumour characteristics, treatments, hospitalisations, and mortality for nearly all cancer patients in England. Of the available secondary oncology databases and national cancer registries, CAS may very well be the world’s leading cancer data asset.

In the UK, as across the world, healthcare stakeholders are considering innovative ways to reconcile individual patient privacy and research, as real world insights can help identify disease patterns and correlate with the precise treatment. Despite the potential value of CAS to impact clinical research, patients and life sciences alike, access to the data is challenging. CAS is highly protected because it includes confidential patient information. Moreover, the data’s value and use are hindered by the long and complex approval process. This slows the development and availability of novel cancer treatments, delays improvements in patient outcomes and obstructs our understanding of a medicine’s safety profile.

Innovative approaches: A gateway to improved data access and real world evidence

Real world cancer data has been used successfully to expand patient access to cancer treatments and improve patient pathways. And external stakeholders such as regulators and payers increasingly rely on real world evidence (RWE) to inform reimbursement decisions. With widening value, new approaches are needed to unlock and harness potentially powerful, real world data sources like CAS.

Committed to protecting individual patient privacy, IQVIA has taken a leading role in addressing these data access challenges by collaborating with various health care stakeholders to develop, test and validate the Simulacrum. Using privacy-enhancing processes and data safeguards, the Simulacrum is a simulated oncology dataset structured to model properties of the data collected within CAS, but which contains no actual patient data and does not compromise patient confidentiality. As the demand for large, robust datasets required to test novel approaches to real world evidence generation increases, synthetic datasets like the Simulacrum may provide a safe, accessible and effective environment for testing algorithms and refining methodologies.

From the Simulacrum, IQVIA has formulated the Oncology Insights Simulator to perform real world analyses in a simulated environment that can then be fully executed on the CAS database without the risk of patient identification. IQVIA’s Oncology Insights Simulator facilitates research, increases our understanding of how to efficiently leverage complex cancer data and reduces the iterative analytical processes typically required of real world evidence generation in oncology. It can be used to conduct clinically relevant and statistically precise real world studies that answer critical questions about cancer patients and treatments. Moreover, by supporting real world studies leveraging a robust, nationally representative oncology data asset such as CAS, the Oncology Insights Simulator can be used to demonstrate the potential of real world end points in Europe and across the globe to rapidly address clinically relevant questions about treatment effectiveness.

Other types of questions that could be addressed include:

  • Is there an unmet need?
  • What are the current treatment patterns and pathways?
  • What are the outcomes for this patient population?
  • What is the comparative effectiveness of these therapies?
  • What are the economic implications of the disease?
  • What is the safety profile of our product?

Once a study protocol has been developed, coding of the simulated database is performed. Those results are reviewed and the validated code from the Simulacrum is sent securely to PHE to run on the CAS database itself. Research leveraging the Oncology Insights Simulator includes the evaluation of treatment patterns for leukaemia patients, the assessment of overall survival for lung patients receiving immunotherapy, and the description of weight loss among cancer patients undergoing chemotherapy.

The future of real world evidence

A wider acceptance of RWE to inform health care decisions, both clinical and economic, has increased efforts to identify, collect and harness patient data, all while supporting confidentiality. Furthermore, health care organisations are exploring broader and more beneficial applications for the real world data being collected. As these applications are being debated, there is a paramount need to leverage high-quality, protected sources of already available data. Is simulated data an answer? We say yes.

Stay tuned

In upcoming blogs we will be exploring how the IQVIA collaboration with Genomics England can drive precision medicine forward and how the Oncology Data Network, a European initiative that complements the role played by cancer registries, can provide insights on the use of anti-cancer medicines, at scale and in near real-time. Along with Oncology Insights Simulator, these innovative approaches support improvements in cancer outcomes.

For further information contact Adam Reich

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