The promise of precision medicine – using information about an individual’s genetic profile and other characteristics to inform clinical management – has fuelled a rapid rise in new innovative targeted therapies. As more and more of these treatments are developed, a new set of challenges are emerging, including how best to identify promising new treatments, how to bring them to market whilst rigorously evaluating their safety and efficacy, how to speed up appropriate adoption of effective novel treatments, and how to monitor use of these therapies to ensure that they deliver on the promise of clinical trials in clinical practice. This World Cancer Day we wanted to highlight some sources of real-world data (RWD) that are available to generate robust and insightful real-world evidence (RWE), and how IQVIA can help you maximise their potential.
The impact of RWE is increasing across the lifecycle of a drug, through clinical development, bringing the drug to market and ensuring its adoption into routine clinical practice. For example:
- RWE is increasingly being accepted as a mechanism to generate insights relating to external comparators – cohorts of patients with characteristics similar to those who are being studied in a clinical trial – to enable regulators to evaluate safety and efficacy of new treatments.
- Payers are also more often looking to RWE when making reimbursement decisions on a new treatment – including factors such as the potential patient population, unmet need, current burden of disease and associated costs of treatment.
- The value of RWD extends into supporting rapid adoption of new treatments – understanding current care pathways, use of different types of biomarker tests in the clinical setting, access to tests and lags between diagnosis, testing and treatment and the impact that this can have on outcomes. These insights can then help identify areas for education, resources, and other support to ensure that patients are receiving the care that is best suited to their needs.
The changing attitudes and increased acceptance of the importance of RWE are reflected in the National Institute for Health and Care Excellence (NICE) RWE framework1. This framework outlines how “real-world data can improve our understanding of health and social care delivery, patient health and experience and the effects of interventions on patients and system outcomes in routine settings.”1
Data sources relevant to Oncology, such as Genomics England, NHS Digital’s Cancer Analysis System (CAS – including the recent addition of CAS Molecular) and the UK BioBank contain genomics and genetic/biomarker information respectively, which are linked to very rich longitudinal clinical data:
- Genomics England was initially set up by the Department of Health and Social Care to deliver the 100,000 Genomes Project. This innovative project involved sequencing 100,000 whole genomes from NHS patients and their families. The role of Genomics England, and the data they have collected has continued to advance which have seen the creation of a robust and secure research environment within which it’s possible to explore this rich dataset. Genomics England and IQVIA collaborate to successfully design and deliver RWE studies together. This dataset is particularly valuable for example in identifying unknown genetic associations, evaluating the impact that non-coding regions have in the phenotype, investigating the impact that different genetic mutational variants have on patient outcomes before a biomarker is implemented in routine clinical care.
- NHS Digital collects data on nearly all cancer patients in England via the National Cancer Registration and Analysis Service (NCRAS, which collects the data that feed into the Cancer Analysis System) and is one of the most granular cancer registries in the world. CAS data are captured from multiple healthcare sources, including hospitals and histopathology laboratories. A recent addition to CAS is CAS Molecular. This includes molecular testing data – leveraging detailed insights into routine molecular diagnostics which are linked to other data such as patient’s demographic profile, diagnosis, treatments including surgical, radiotherapy and drug therapy and their overall survival. IQVIA has worked extensively with CAS over the past 4 years and has recently completed a pilot of CAS Molecular which has provided valuable insights into the most appropriate use cases for this dataset and how to generate these insights robustly and efficiently. This dataset provides insights into what genetic/biomarker tests are being used in routine clinical practice, when these tests are being carried out in the patient’s journey, and can also be linked to the rest of the CAS dataset to provide additional information on the linkages between the biomarkers that are identified, treatment received and outcome.
- The UK BioBank is a large-scale biomedical database and research resource that contains genetic and health data. The data within the BioBank covers information from half a million UK participants, aged between 40-69 years of age. Patients were actively recruited between 2006 and 2010 throughout the UK. This database contains 200,000 records of whole genome sequencing (WGS), with an additional 300,000 to be made available by the end of 2023. This rich WGS data is linked with lifestyle, biochemical and health outcome data, and will further inform and advance drug discovery and development.
Turning data collected through clinical practice into robust RWE can be a challenge. It can take a multidisciplinary team of experts who have experience with the development of algorithms, code lists, programming and protocols to create insightful and powerful analysis. Here at IQVIA, we can help with that. Recent innovations with molecular data further contribute to the power of these well-established data sources. Accurately interpreted and well-defined analyses offer an exciting opportunity to contribute towards improving outcomes for cancer patients.
To understand how IQVIA’s team of RWE experts can support you to leverage these powerful RWD sources, contact us here: stephen.benson@iqvia.com.
Reference
1https://www.nice.org.uk/corporate/ecd9/chapter/overview
Source: https://www.iqvia.com/locations/united-kingdom/blogs/2023/02/the-role-of-real-world-evidence-in-precision-oncology