By Michael Eckrote, vice president, technical solutions
In a world where precision medicines are becoming more and more common, and the development of therapies designed for n of 1 populations are increasingly prevalent, patients themselves are put at the forefront of the development paradigm. The need for a clear understanding of the patient’s journey is more important than ever, yet pharmaceutical manufacturers are still struggling to connect the dots.
With this said, the concept of incorporating a patient’s real-world data (RWD) creates an exciting opportunity to start to develop rich patient narratives, leverage longitudinal medical records for decision making, while also generating observations prospectively, beyond the confines of any trial or investigative site. And by bringing RWD into the fold, researchers can start to generate insights away from common trial endpoints, examining all of the additional data patient’s generate in the broader healthcare and societal ecosystem. Researchers; however, are struggling to realize all of these benefits because of the limitations with legacy technologies in making disparate and fragmented healthcare data interoperable while maintaining privacy and governing all of the data usage rights and patient permissions.
In this article, we will follow a patient’s journey through a clinical trial, demonstrating the benefits of syncing RWD rather than using traditional linking technologies:
Pre-Trial: Future-proofing the study
Meet Brian who recently suffered an acute ischemic event. During his stay in the hospital, Brian’s care team makes him aware of a unique opportunity to participate in a clinical trial where researchers are exploring the use of a new drug that, in early studies, has appeared to be effective in reducing the likelihood Brian would suffer a follow up ischemic event.
Realizing the benefits that RWD can bring to clinical trials long term, the study sponsors proactively enabled investigators with a solution to synchronize patients with their broader healthcare data. This meant Brian’s personally identifiable information (PII) and permissions needed to be governed in a HIPAA-compliant manner. After Brian gave his consent to both the trial and access to his RWD, the investigators needed to ensure that his RWD was discoverable. With legacy tokenization techniques where a new token is created for each individual in a dataset, even if that person was previously identified in a different dataset (i.e., a medical claims dataset and a labs dataset), this would be a challenge. HealthVerity uses a unique but persistent HealthVerity ID (HVID) that accurately synchronizes patient identities across data sources, creating a single source of truth. That synchronized approach allows us to offer RWD Pre-Check where researchers can check on the availability of a participant’s RWD before even enrolling them in the study, using a simple webform.
In this case, confirming RWD was available for Brian was very valuable in determining if he met the study protocol’s inclusion and exclusion criteria. While several of the criteria were readily available for the investigative team in the hospital’s electronic medical record (EMR) system, including Brian’s current vitals, his demographics and recent medical history, the protocol also required investigators to confirm the patient met certain biomarker criteria, specifically, a few notable lab tests were not clearly captured upon Brian’s hospital admission. With a universal HVID created for Brian, investigators were able to seamlessly synchronize Brian’s longitudinal patient records from the trailing six months, including data collected from lab tests taken during Brian’s encounters with his primary care physician at his annual physical and semi-regular check ups, with the hospital EMR data and trial data as the study progressed. Discovering the RWD upfront allowed the trial team to make a more informed decision in regards to enrolling Brian in the study. This same data, which HealthVerity can provide to sponsors in both a de-identified or an identifiable fashion while meeting HIPAA requirements, can be used to better understand the patient journey prior to Brian’s first clinical site visit, informing protocol design and contextualizing early trial data.
During the trial: Recovering patients lost to follow up
With all consents in place, Brian is now participating in the study and receives the study drug, which he takes daily for several weeks. During that time, Brian attends semi-regular visits to the trial site, allowing study teams to collect a myriad of different data elements in regards to his current medical status; however, as time goes on, Brian’s life gets back on track. With physical and occupational therapy visits, an attempted return to work, and trying to resume some sense of his normal activities of daily living, Brian finds himself unable to continue to adhere to the trial’s visit schedule and loses all contact with his clinical study care team. In the research world, this is what we call a patient who is “lost to follow up.”
Traditionally, when Brian becomes non-compliant with the study protocol, sponsors have lost an important part of their evidence generation package needed to determine if the drug is both safe and effective enough to be approved by the regulatory bodies evaluating them. But this trial proactively garnered Brian’s consent to synchronize his trial journey, with the data he generates in the broader healthcare ecosystem, which we already know is available. Through this strategic approach, Brian continues to provide novel insights and evidence to the study’s overall data analysis set, as researchers can closely monitor if patients like Brian have had any recurring diagnoses, new hospitalizations or have gone on to receive other similar therapies. For study sponsors, this is the difference between losing a patient to follow up versus creating net-new insights, which could make the difference between receiving approval for the therapy or not.
After the trial: Ensuring long-term follow up
At the conclusion of the trial, the FDA provided guidance to the pharmaceutical manufacturer that additional clinical surveillance would be needed. Many of the endpoints in which the study team are required to monitor, are readily accessible in Brian’s RWD, thus, the trial team can effectively monitor Brian’s health from a distance through the synchronization to his medical records. By leveraging this strategy, clinical teams can easily track common outcome measures like time to follow-up event, adverse events, new hospitalizations and more. This means not only does Brian spend less time at academic research hospitals and more time resuming his favorite hobbies, but it also means both sponsors and sites will garner important insights in a much more cost effective, burden-reducing way, enabling transformational therapies to continue to serve the patients who need them. This ability to continually monitor trial participants’ long-term can be particularly beneficial for cell and gene therapies where there can be requirements from regulatory bodies to survey patients for up to 15 years after the trial is over.
Throughout the trial: Managing patient permissions and data rights
Managing all of the patient permissions and consents for both the trial and RWD access, as well as the usage rights for the RWD, particularly with determining who can view what when dealing with both de-identified and identifiable data, can be dizzying. With our synchronized solution, HealthVerity governs all of this for you.
HealthVerity consolidates and seamlessly manages consents and data rights, opt-ins, opt-outs and expirations across individual clinical trials, various brands and enterprise wide, synchronizing with your most critical workflows to provide a single source of truth, ensuring proper compliance so you can act more decisively.
Letting the RWD FLOW
As you can see, synchronization to RWD isn’t just about accelerating a new therapy’s time to market and likelihood of receiving regulatory approval, but rather, the role it plays in supporting patient journey mapping, generating novel participant insights, as well as reducing the burden often placed on patients and sites to comply with study protocols.
With RWD coming to the forefront of many pharmaceutical development strategies, HealthVerity is excited to see the value it brings to the entire clinical continuum with HealthVerity FLOW, a fully governed, HIPAA-compliant and 21 CFR 11-certified SaaS solution that optimizes trial insights throughout the clinical research stages, from recruitment and enrollment screening to external control arm and long-term follow-up studies. By providing the ultimate source of truth in patient identity resolution across sources, with built-in privacy and governance of data usage rights and patient permissions, HealthVerity FLOW enables the efficient discovery and exchange of a near limitless combination of both de-identified and identifiable data at a record pace. This modularized solution allows the data to flow where you need it, when you need it, how you need it throughout the trial lifecycle.
