Clinical Trial written in search bar.jpegPharmaceutical Competitive Intelligence (CI) teams within pharma have always been early adopters of data driven insight. Individual data points aggregated into an interconnected dataset allow pharma CI professionals to access, manipulate, and keep up with constant change. 

As such, it’s come as no surprise that evidence aggregation platforms have found strong use cases in this area of pharma, helping manufacturers generate new insight on market dynamics which aids them in fully understanding the competitive landscape.

A case study of how an evidence aggregation platform has been used should be a helpful example.

Case Study: Oral vs. Injectable Drugs

Once approved, an oral drug in development will compete with currently marketed injectable drugs. There was a need by the oral drug’s manufacturer to understand safety differences between currently marketed oral vs. injectable products in order to fully understand the competitive landscape, identify points of differentiation between products, and pinpoint specific future evidence generation opportunities.

The evidence aggregation platform was used to identify products on market with the same active ingredient that had both oral and injectable delivery, and then to probe adverse event reporting differences between active ingredients that are administered both orally and by injection.

There were some initial ideas on what types of side effects could show differences, but since the evidence generation platform was able to quickly show all of the spontaneously reported adverse events, as well as calculated disproportional reporting rates, and reporting incidence rates, it was simple to select specific MedDRA preferred terms (PT) and broader Standardized MedDRA Query (SMQ) topics that were seen to show the largest differences between formulations of the same drug.

Thrombocytopenia and thrombocytopenia-related disorders were reported to FAERS disproportionately higher with injectable products on the market compared to oral formulations. Since the evidence aggregation platform being used for this example had embedded MedDRA ICD-9/10 mapping, validation of the differences in these types of events could be seen using active surveillance with claims data.

The result of this data collection was deep understanding of how the oral product could be marketed against the competing injectable product. With this insight in hand, the manufacturer could more effectively develop a marketing and clinical strategy to take advantage of the safety differentiation.

Advera Health’s Evidex™ is an evidence aggregation platform that makes evidence collection and generation easy though a simple to use, yet powerful web-based application. To learn more about specific use cases of evidence aggregation platform's like Evidex for pharmaceutical companies, managed care organizations, hospitals, and product liability insurers, download our new White Paper, Use Cases for a Pharmaceutical Evidence Aggregation Platform- Combining Clinical Trial Results with Real World Data.

 

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Jim Davis, EVP Advera Health

Topics: Evidex, Pharmacovigiance 2.0, Drug Safety, Clinical Evidence

Jim Davis

Written by Jim Davis

As Executive Vice President, Jim is responsible for the commercialization strategy for Advera Health Analytics.