Unlocking insight from patient data while enhancing privacy
In 2017, IQVIA created the European Oncology Evidence Network (OEN) in partnership with a group of leading oncology hospitals. The mandate of OEN is to “collate comprehensive, up-to-date, and validated data on how anti-cancer medicines are actually used in clinical practice for all forms of cancer, in all patients.”
Privacy Analytics, an IQVIA company, joined the project to provide expert advisory services and software to enhance the privacy of patients represented in the OEN’s datasets.
The growing complexity of cancer treatment
While innovative new treatments are saving lives and improving outcomes for cancer patients all over the world, cancer treatment has become increasingly complex and expensive. Public health systems struggle with limited resources and affordability while public concerns have risen significantly.
The External Factors
Regulatory restrictions apply
OEN’s goal is to improve the quality and cost-effectiveness of cancer treatment and care to individual patients based on their specific needs. To achieve these objectives, OEN needed to collect and analyse as much real-world data from as many cancer patients as possible while enhancing privacy.
This sensitive, personal health information had to be transformed to meet privacy and regulatory obligations, while retaining its value for research. OEN and its stakeholders are subject to the European Union’s General Data Protection Regulation (GDPR). This law strictly governs data protection and privacy in the EU and the European Economic Area (EEA). It also addresses the transfer of personal data outside the EU and EEA areas.
In addition to transforming personal information in a manner that would satisfy GDPR privacy requirements, no patient-level data ever leave any of the hospital cancer centers.
The data must be transformed to protect privacy and any desired analysis can then be conducted within each cancer center. Only the aggregated results of analyses are shared with other members of OEN.
An automated platform that transforms data at speed and scale
Each OEN hospital required three components within their control and oversight:
1. A system to extract, link, and combine all the information relevant to an individual oncology patient from different sources with the information of other patients into a single research data repository.
2. A system to transform all this data to enhance privacy by replacing directly identifying information with pseudonyms [known as pseudonymization]. Each hospital established its own rules about which specific patient identifiers were pseudonymized.
3. A system to conduct the desired analysis.
Privacy Analytics’ Eclipse software enabled pseudonymization
Teams from IQVIA worked onsite with four OEN partner hospitals – in the U.K., Portugal, France, and Germany. IQVIA designed and deployed the automated data pseudonymization filter at the hospital sites, to reduce the manual effort required for the whole process.
The GDPR defines pseudonymization as “the processing of personal data in such a way that the data can no longer be attributed to a specific data subject without the use of additional information.” Pseudonymization replaces directly identifying information for a patient within a data record with one or more artificial identifiers, or pseudonyms. There can be a single pseudonym for a collection of replaced fields or a pseudonym per replaced field.
Privacy Analytics’ Eclipse was installed at the three hospitals that lacked the means to perform data transformation on their own. This enterprise-level software platform transforms vast stores of sensitive data, safely and at scale, in an automated process.
The OEN partners also wanted to retain the ability to re-link any individual patient should an analysis reveal an immediate need for some kind of intervention of benefit to the patient.
To retain the ability to re-link, while also remaining compliant with GDPR, Privacy Analytics developed customized data encryption features, “Key Management” and “Secure on-demand re-linking,” to transform the patient data in a way that can be decrypted in a secure fashion.
From the perspective of the end user, Privacy Analytics’ Eclipse is practically a magic box—real-world patient data enters and then passes through a “filter” where the transformation takes place. Pseudonymized data exits with the necessary controls in place to meet regulatory standards for privacy, ready for analysis and use in observational studies.
Safe data-sharing to improve care, reduce costs, earn trust
OEN made it possible to conduct high-quality observational oncology studies for both hospitals and pharmaceutical companies on treatment outcomes and quality of care.
With the combination of proven expertise, a leading data transformation platform, and the deployment of specialist personnel on site, IQVIA and Privacy Analytics helped OEN partner hospitals enhance their existing systems. This enabled the hospitals to create bespoke, transformed data sets suitable for analyses in observational studies. The insight from these studies contributes to the efficiency, accuracy, and cost-effectiveness of patient treatment.
“When you have the capacity to transform patient data, at speed and at scale with a standardized model, to protect privacy and meet strict regulatory guidelines such as GDPR, you can share data safely with great results,” said Prashan Rampersad, Solution Architect, Real-World and Analytics Solutions, for OEN.
Creating a future-proof foundation for innovation
In particular, the adaptation of the powerful Privacy Analytics’ Eclipse platform has made it possible for Europe’s leading oncology hospitals to safely and responsibly unlock the vast potential of their patient information. In so doing they are able to help tailor patient treatment while addressing the growing logistical and financial challenges around cancer treatment. The benefits extend beyond these individual hospitals to the entire drug development ecosystem.
“Forward-thinking executives in both the clinical and pharmaceutical settings understand that safe data-sharing is becoming increasingly critical to earn stakeholder trust and improve patient outcomes,” added Mr. Rampersad.