In our ongoing series, we have been discussing the value of real-world data (RWD) throughout the pharmaceutical life cycle. We have already reviewed how RWD can accelerate the path to regulatory approval by leveraging it before a clinical trial even starts to inform study design, aid in site selection, discover and recruit ideal patients, and enhance enrollment screening. We also explored its value during the trial to limit the impact of patients lost to follow up, conduct concurrent or control arm studies, and monitor healthcare utilization outside of the study. In this installment, we will delve into the benefits RWD can bring long after the trial.
Superior safety surveillance
Synchronizing clinical trial participants with their RWD allows you to conduct long-term follow up, including supporting ongoing safety requirements. Leveraging RWD for safety surveillance can provide insights on long-term outcomes, adverse events, survival, and the overall safety and efficacy of treatments.
Compare and contrast
Comparator studies are increasingly being used due to pressure from payers and regulators. RWD can meet this need by enabling more efficient evaluation of the relative efficacy of a treatment with respect to other drugs on the market, providing the evidence payers require to cover the costs associated with the new treatment.
Research vulnerable populations
Certain populations are often excluded from participating in clinical trials, such as pregnant women. RWD can be used to analyze these subgroups and fill in any evidence gaps. The HealthVerity Maternal Outcomes Masterset (MOM) was built for this purpose, providing registry-quality data on over 12 million pregnant women, with more than 3 million newborns synced to their mothers, to support long-term, multi-year pregnancy studies.
Discover new indications
Using RWD, you can also determine the effectiveness of your product in treating additional indications and gain the insights needed to seek regulatory approval.
Keep the data flowing
To keep the insights garnered from RWD flowing after the clinical trial, you need a solution that can capture the clinical trial participants’ personally identifiable information (PII), manage patient identity and govern patient permissions beyond the trial in case of changes in preferences, as well as the ability to retrieve RWD on demand while remaining fully HIPAA compliant. HealthVerity FLOW provides this end-to-end solution within a 21 CFR Part-11-certified platform.
By implementing HealthVerity FLOW at the beginning of the trial, you can have a single, privacy-protected source of truth for the clinical trial participants’ identity and consent preferences, viewable on an enterprise-wide dashboard, that allows you to seamlessly exchange data from the nation’s largest healthcare and consumer data ecosystem or other third-party sources in a fully HIPAA-compliant manner, powering your long-term follow up studies for the long haul.
In our final installment in this four-part series, we will discuss the value real-world data can bring to commercial operations and go-to-market strategies.
Learn how the data can keep flowing long after the clinical:
