Each month, we investigate a different Clinical Trial Case Study that posed us with a challenging question; this time it’s a look at an orphan indication in HEMATOLOGY, and significant cost reductions for the sponsor:
We asked ourselves:
Scenario: A Phase IV study was required by the FDA as a condition of approval of an orphan drug. The sponsor was faced with monitoring, managing, and locking data for a 12-month study conducted at 100 sites.
Criterium’s solution enabled the client to eliminate most of the scheduled monitoring visits. Criterium’s diligence and centralized system meant that monitors only had to visit sites that had problems.
What If: If the client had used traditional methods, the cost would have soared for a product that has modest revenue and it would have taken much longer to provide the data to the FDA and the prescribing community.
Results: Criterium’s centralized real-time data accession utilizing Automated CRFs and Interactive Voice Response (IVR) medical history and patient diary application saved the client $1 million to $1.5 million in clinical monitoring and data management costs. In addition, the data were satisfactory for rapid submission to the FDA for conditional approval, were provided to the medical community to support the indication for which the drug was approved and numerous publications resulted from this fairly large body of data for this orphan indication.
Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com