Our rapidly increasing genetic-level disease knowledge and exponential technology advances are changing the way we manage health. But we may never fully seize these opportunities if we limit our clinical research approach to past models. Changing societal attitudes around sharing personal data and new consumer technology make innovative study designs and operations possible. This includes new possibilities in designing and operationalizing patient registries by moving to “virtual” setups.
Registries can be powerful tools to observe the course of a disease, understand variations in treatment and outcomes, examine factors influencing prognosis and quality of life, describe patterns of care, assess effectiveness, monitor safety and harm, and measure the quality of care.
Patient-centric registries offer many benefits
Patient-centric registries can run at a fraction of the cost of traditional approaches while improving participant engagement. The approach can also capture richer, more accurate data about what affects patients’ lives and well-being most. Where traditional patient registries have complex consenting processes, extensive data capture forms, site recruitment and activation challenges, and are costly, virtual registries can minimize these common hurdles.
Leveraging digital approaches and technology, the virtual registry shifts the center of the research from the investigator to the patient and builds all research processes around the patient rather than the site. Summarizing the main differences between a site-centric and a patient-centric registry, we see that technology simplifies both key processes, such as recruitment and consenting, as well as the collection and handling of data.
The table below describes key differences between traditional and virtual registries.
|Study||Traditional site-based registries||Virtual registries|
|Patient recruitment||Invitation from patient's treating physician, adverts where allowed||Social networks, EHRs, internet searches, peer-to-peer recommendations|
|Screening and informed consent||Inclusion and exclusion criteria screening done at site by investigator
Paper-based informed consent by investigator
|Inclusion and exclusion screening managed through software
e-consent given through registry software and understanding verified through questionnaire
|Institutional review board (IRB)/ethics approval||Local IRB/ethics submission at each investigator site||One IRB/ethics submission at the coordinating site|
|Data collection||Collected at regular site visits||Collected remotely via ePRO and mHealth technology|
|Data entry||Data entered after collection and later transcribed into the study database||Data collected in real-time directly into CRF system|
|Interaction with investigators||Regular face-to-face site visits||Telemedicine and virtual communications|
|Data quality||Regular on-site data verification and review monitoring||Remote risk-based monitoring, medicine adherence checked by digital devices|
In the above, you’ll see that patient follow-up, which has been a common issue, is improved in a patient-centric registry approach. A central digital platform connects and supports all parties (patients, sponsors, investigators) in their workflows and tasks.
Hurdles to building a virtual registry
There are several considerations that sponsors of virtual registries need to consider around preparing, operating, and closing a virtual registry. Key considerations include:
Encouraging implementation of virtual registries
By developing and implementing virtual registries in low-risk areas, such as natural history studies, we can start to create familiarity and confidence in such designs. Tackling these low-risk areas first would allow the research community to learn and share, creating best practices.
Regulators are increasingly open to and encouraging of novel registry designs. However, achieving change is a complex and difficult process; in many cases, the internal culture of research teams and the interconnected interests of different stakeholders adds to the difficulties. Focusing the case for change on cost reduction, while important, may not be the most successful approach. We have found that identifying and championing the wider benefits of such an approach will be key to winning over the range of stakeholders from the medical community, commercial life sciences R&D functions, participants, regulators, payers, and society.
As we see virtual registries and other virtual research approaches gaining traction across different disease areas and geographies, study sponsors need to consider how they can bring digital solutions into their R&D units and how digital and patient-centricity capabilities can create a platform that spans across the entire pharmaceutical value chain.
Chris Isler is a life sciences expert at PA Consulting
This article features insights from PA's Transforming real-world evidence through virtual patient registries report co-written by Chris Isler, Simon Hall, and Callum Caldwell.
Our new value-based care research shows why putting patients at the centre of healthcare is important and how to do it