Historically, clinical trial data and real-world data (RWD) have existed in silos. With increasing technology, experience and regulatory guidance, we have been able to break down those silos and evolve the clinical development process to accelerate and improve the efficiency of research.
Linking RWD with clinical trial data provides benefits throughout the entire development lifecycle:
Before the Trial
RWD associated with clinical trial participants can be leveraged to inform study design and recruitment. Researchers can gain a more comprehensive understanding of the patients’ medical history, their baseline, and whether they meet inclusion or exclusion criteria. RWD can also supplement information about the condition, such as disease onset, trajectory, past healthcare utilization, diagnoses and treatments, and provide insight into the patient journey leading up to randomization within the trial.
During the Trial
Researchers can design and implement regulatory-grade synthetic control arm studies, as well as support concurrent safety and healthcare resource utilization studies by linking to RWD. Additionally, with RWD, sponsors can find trial participants once thought lost to follow up and discover if participants are receiving healthcare outside of the study.
After the Trial
The linked patients can continue to be studied by leveraging RWD to support ongoing safety requirements and address questions related to long-term outcomes and value. RWD can also be used to analyze subgroups unable to be studied during the trial, such as pregnant women.
HealthVerity recently hosted a webinar with our partner Medidata, a leading provider of digital clinical trial solutions including Medidata Link, that discussed four practical steps for building linkage into your program plan. If you missed the webinar, here’s what it covered:
Step 1: Address consent, enroll patients, and securely store and collate personally identifiable information (PII)
If you’re going to link to a trial participant’s RWD, it is a best practice to get their consent, even if the data is de-identified and HIPAA-compliant. Sponsors can use either a single consent form for participating in both the trial and RWD linkage or a separate consent form can be used. There are pros and cons to each, however, what’s important is getting the consent upfront rather than trying to capture it from participants later. Consent is usually high, typically between 85%, as participants want to help advance the science and treatment options for their condition.1
Once consent is given, study sites need to collect PII, such as name and date of birth, for both participation in the trial and linking to RWD. The PII then needs to be securely and compliantly stored over the long term. By enlisting partners, such as Medidata, the consent and PII collection and storage process can be seamlessly linked into your clinical trial workflow to reduce site burden. Medidata offers options for either the site or the participant to enter the PII, or for it to be captured through wearables and then securely stored in the Medidata Clinical Cloud data hub.
Step 2: Implement identity resolution and tokenization
Tokenization replaces the patient’s PII with an identification number, which HealthVerity refers to as an HVID, that can then be linked to RWD records with the same ID number. With the HealthVerity IPGE platform, an integrated technology and RWD infrastructure based on the foundational elements of Identity, Privacy, Governance and Exchange, HealthVerity goes beyond traditional tokenization, which only allows patient records to be linked data source to data source. Instead, we provide patient identity resolution where our HVID is matched to a referential database of over 330 million patients, providing a persistent, universal ID that can be accurately linked over time and across data sources. With Medidata and HealthVerity, this is all done seamlessly in one workflow.
Step 3: Supplement clinical trial data with RWD
With identity resolution and the HVID, RWD from HealthVerity Marketplace, the nation’s largest healthcare and consumer data ecosystem, consisting of over 75 unique data sources and more than 150 billion de-identified transactions, can be licensed to supplement clinical trial data and add more color to the patient story. This provides the flexibility to select the data that makes the most sense for your research and to add additional data types as questions come up or as the study evolves. Essentially, this future proofs your study, allowing for trial refinement, concurrent analyses and long-term analytics with no additional burden to the trial sites or participants.
Step 4: Consider long-term consent and data management
It is essential, and required by Institutional Review Boards (IRBs), to manage participant consent long term and provide a pathway for patients to withdraw their consent, even after the trial concludes. While this is a rare event, it is something sponsors need to consider and make patient friendly. Medidata offers a Long-Term Consent Withdrawal offering to make this process efficient and scalable. With this solution, withdrawals are handled through a patient-facing form or central call center and the status is updated immediately and synced with HealthVerity. The patient’s data is then removed from any future data licensed through HealthVerity without any additional burden on the patient.
By enlisting partners like Medidata and HealthVerity early, these steps can be easily implemented, allowing you to link and supplement your study with RWD before, during and after the trial for unrealized insights into the patient journey and future proofing your study. Click here to watch a recording of our webinar, Converging Clinical Trial and Real-World Data to Generate Real-World Evidence Breakthroughs, or click here to learn more or schedule a demo.