The future of patient registries: Leveraging technology for superior data and insights

The healthcare industry has a growing need for real world evidence (RWE) and the capture of holistic longitudinal outcomes. This evolution is a result of payers, providers, regulators, and patients requesting more information about how pharmaceuticals affect patients at each stage of the disease and the drug development lifecycle.

RWE provides valuable insights for all stakeholders into drug safety, product effectiveness, and policies that inform patient care and quality of life.

Traditionally, patient registries have been a valuable source of RWE, but challenges related to the scope and scale of data collection have created limits on the amount of patients and the data that can be collected and its usefulness across various stakeholders.

Recent advancements in technology have eased some of these limitations, facilitating a greater depth and breadth of data collection. These improvements have provided stakeholders with higher-quality information to drive better analysis and decisions regarding patient care.

Patient registries: An important means of assessing drug safety and effectiveness

The capture of patient-generated data in patient registries is essential in providing researchers and other stakeholders deeper knowledge related to diseases, outcomes, treatment effectiveness, patient safety, and patient experience in real world settings.

However, the traditional means of collecting patient data poses a burden to sponsors, physicians, patients, and caregivers, and impacts the types and amount of data collected. For example, factors including the length of study follow-up and the need for in-person clinical assessments impact patient participation, while also increasing the data collection burden on physicians. Likewise, patient-reported information collected without the right measurement strategy and aligned instruments may not produce quality data and insights.

New technologies offer an opportunity to overcome these obstacles and provide holistic RWE for longitudinal observational studies pertaining to patient characteristics, clinical management, treatment, and outcomes for diverse groups of patients. By re-imagining registries as scalable, adaptable, and patient-centric RWE platforms, healthcare organisations can transform them into strategic assets that collect data to address a range of different evidence needs over the course of drug development and commercialisation.

Higher-quality RWE data, more diverse data sources

Advances in digital health technologies, coupled with expanding data access, interoperability, and linkage landscape have created a wider variety of RWE data sources available to organisations. Modern registries now include patient-reported outcomes, disease-specific clinician assessments, administrative claims, electronic health records (EHRs), and lab/imaging results.

Additionally, digital and remote technologies and services, including direct-to-consumer recruitment, virtual site services, telehealth, mobile phlebotomy, and remote patient monitoring tools, offer the ability to support high-quality real world data collection with a lower administrative burden. Further, advanced registry platforms bring the capability of processing and curating larger amounts of complex RWE data at lower costs, while maintaining data provenance and audit trails of the curation process.

By integrating advanced technology into existing workflows, healthcare organisations can streamline data collection across multiple sources, reducing the time required to collect data. With studies that are more accessible at home and data collection methods that are less onerous, patients are more willing and able to participate in research initiatives.

For example, registry participants can now elect to use smartphone study applications and wearable technology to provide both active surveys and passive sensor data on sleep and activity levels; helping researchers gain unique insights pertaining to patient symptoms, experiences, and outcomes. These advancements also help registry participants minimise repetitive, time-consuming tasks, and reduce the barriers to enrolling in RWE collection studies.

Depending on the patient population, registry technologies can enable either more or less active, engaged participation based on participant preferences.

Four trends driving higher RWE in patient registries

With the above technological advancements, patient registries are poised to transform as effective and efficient RWE generation tools. Below are four trends in the space to watch:

• Growth in decentralised clinical trial platforms that support hybrid and direct-to-patient study designs with better patient recruitment, data collection, and engagement functionality.
• Increased prevalence of connected wearable devices, such as sleep and activity trackers that deliver continuous data streams on patients’ health, as well as their lifestyle habits and outcomes.
• Enhanced data sharing through advancements in interoperability standards and more-sophisticated infrastructure for clinical and EHR data access, retrieval, and automated abstraction.
• Ability to link study data to existing secondary databases and datasets through the growing use of tokenisation and linkage pathways, which will break down silos, foster better collaboration, and support more robust evidence generation.

Patient registries will continue to evolve toward generating RWE that positively influences drug development, patient care, and medical research. Emerging technologies and advanced platforms are already helping healthcare stakeholders conduct better research and generate more valuable RWE from patient registries to accomplish just that.

About the authors

Emily Bratton has been in the pharmaceutical industry for 15 years, contributing to late-phase observational epidemiology research teams. As category lead of safety evidence for regulators, Bratton works across IQVIA’s real world solutions business to ensure customers connect with the right people and design the right solution for their research needs – particularly, evidence generation for regulators. Prior to her current position, she led the scientific development, analysis, and interpretation of observational studies (both retrospective and prospective) and low interventional clinical trials. Bratton received her PhD in Infectious Disease Epidemiology from the University of North Carolina at Chapel Hill.

Ian Bonzani is a senior leader in global real world technology solutions at IQVIA. In this role, Bonzani leverages his scientific background and healthcare consulting experience to design and implement large-scale real-world data and registry platforms that provide value across stakeholders by optimising specialty care coordination, quality improvement, and research delivery. Bonzani has been with IQVIA for 15 years, managing large, global projects for pharmaceutical companies, providers, and other healthcare organisations. Prior roles include data and evidence strategy and implementation roles in real world analytics solutions, pricing & market access, and thought leadership functions. He is a Regenerative Medicine PhD graduate of Imperial College London and has a BSc in Biomedical Engineering from WPI.