When first talking with drug safety departments, we often get asked how our platform is different than systems that they already have in place. The key difference between traditional signal detection software and a drug safety evidence aggregation platform comes down to the types of data they each support, the flexibility in which those data are supported, and the much broader use cases available through an evidence aggregation platform.
Drug safety data from various sources are needed throughout a drug’s lifecycle to support a wide range of regulatory requirements, clinical decisions and planning, as well as commercial positioning and evidence generation. These data can be categorized into three buckets: company owned, vendor curated, and licensed data.
Company owned data include those captured in a clinical safety database or the data that are received post-marketing from spontaneous reporting that are stored in internal databases. Overlaying a front-end on these databases has been at the heart of traditional signal detection software. The process with legacy software providers is long and complicated, with a significant investment needed in terms of both budget and time. The largest organizations have the resources needed to make this investment, however the configuration is not flexible and the software itself is typically used by only a handful of experts. Smaller organizations who have a need for signaling on their own data are often forced to rely on 3rd party consultants to either administer the software or to run the necessary analytics on behalf of the organization.
By contrast, a drug safety evidence aggregation platform is agile and flexible, while still maintaining analytical rigor. If the platform has an easy to use front end, then users do not have to be “experts” or even technically trained. During implementation of the evidence aggregation platform, users are on-boarded using the curated data preloaded in the platform.
Vendor curated data includes FDA Adverse Event Reporting System (FAERS), WHO’s Vigibase, and the various, unstructured data that exist such as clinical study results that are published in government registries like clinicaltrials.gov or found in publications, abstracts, and poster presentations. FAERS data have long been included in traditional signal detection software, but it’s use has been limited to certain power users or dedicated informatics teams. An evidence aggregation platform makes these data and the related analytics easy and provides for a robust source of insight.
Curated study results data have long been restricted to time consuming literature reviews and manual collection processes. Safety science and epidemiology teams have historically mined these data by hand, but manually scaling and updating these data is nearly impossible.
Databases of study results now exist that can be pre-loaded into an evidence aggregation platform. Analytics included in the platform can provide for on-demand pooled meta-analyses at the AE level, and then mapped and matched back to both company owned and curated FAERS data.
Licensed data are those data assets that an organization licenses from different vendors. Examples of these data include multi-payer claims, social listening, search query logs, and provider transcripts. These sources vary widely in structure and use case and can often sit in different areas of the organization. For example, multi-payer claims data, while having a clear benefit for drug safety teams, are often held by outcomes groups, and the data are not easily accessed or shared outside of the group.
Evidence aggregation platforms can corral these licensed data into one interface by matching and standardizing outputs to map back to both company licensed and public data. This allows for investigation into the data across disparate data sources and 360° view into safety issues.
Drug safety evidence aggregation platforms are becoming a vital tool for pharmacovigilance departments at pharmaceutical manufacturers.
Download a copy of our new white paper, Drug Safety Data to Support the Entire Life-Cycle: An Introduction to Drug Safety Evidence Aggregation Platforms.
The white paper contains specific use cases for a drug safety evidence aggregation platform designed for all functions within a drug safety department, including signal detection, safety science, and epidemiology.