Drug safety is often equated with post-marketing pharmacovigilance, something that is required by manufacturers only after their drug is approved. But when drug safety data are presented in an evidence aggregation platform there are very strong use cases in pharmaceutical competitive intelligence, health economics and outcomes (HEOR), and R&D. An evidence aggregation platform takes multiple sources of information and boils it down into actionable insight. That insight often has use cases that span all departments and can meet the demands of various priorities.
Take for example a pipeline product has been put on clinical hold by FDA due to an unexpected serious adverse event in a trial. The trial’s sponsor needs to act fast to lessen the impact of the delay. Is this something that should be expected? Do competitor drugs have similar profiles? Will the adverse event impact market potential?
These types of questions need to be answered outside of departmental org charts. Various stakeholders need to come together to provide insight and the first order of business is to ensure the proper data are available. The sponsor needs to establish a benchmark rate of adverse event occurrence across all drugs for the same indication in past clinical trials as well as in real world data. This is where an evidence aggregation platform is extremely beneficial.
First, an evidence aggregation platform should allow the sponsor to quickly identify all trials, for all drugs in the indication that presented the same or similar adverse event. With an evidence aggregation platform, data reporting delays, non-standardization of results data, and other incongruities are corrected, providing for easy search and retrieval of data points.
Second, given the results data are captured as metadata from each trial, pooled rates for the adverse events for each drug can be calculated to identify incidence rates drug-by-drug, rather than trial-by-trial. An evidence aggregation platform can then combine drug-by-drug rates to a combined pooled analysis to establish an indication-wide baseline adverse event rate, as seen in clinical trials.
Next, these clinical trial results data can be matched to spontaneous reporting in FAERS, combined with patient utilization numbers, to establish a real world adverse event reporting rate. Using customized analytics on claims data, also loaded into the evidence aggregation platform, allows for an additional “version of the truth,” giving the sponsor a 360⁰ view, and a true baseline rate for the adverse event.
The result of cross-functional use of an evidence aggregation platform allows for the key questions to be answered quickly, helps to accelerate the lifting of the clinical hold, and provides a better understanding of how the adverse event impacts potential market share.
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, see our comprehensive guide to using drug safety data.
Jim Davis, EVP Advera Health Analytics