An End-to-End Data Management Strategy for a Complex Oncology Program

posted on March 15th 2016 in Complex Trials Case Studies with 0 Comments /

Our client, a Biotech company in the Boston area, is focused on developing new therapies for oncology. Oncology studies are notably more complex as the protocol requirements include managing multiple cohorts, managing dynamic cycles of treatment, a greater number of inclusion and exclusion criteria. These studies mostly include an expanded number of external data streams including Local Labs, Central Lab, PK/PD, Biomarketers to name a few. Ultimately, an oncology program results in a greater amount of data to be aggregated and analyzed.

Our contact was a new leader for the Data Management organization and quickly discovered two areas of concern. First, the existing vendor that was supporting data analytics had data reports that did not correlate to the study results. This dichotomy resulted in a loss of trust in the data being published. Secondly, the study builds performed for three protocols to capture data in an EDC system were poorly designed, threatening the conduct timelines and other milestones.

Our Solution
The eClinical Solutions team focused first on redesigning the studies to leverage the EDC system capabilities. The team discovered that the previous provider had been simply converting each CRF in the protocol into individual eCRFs without applying any EDC best practices and not considering the effectiveness at sites.

We implemented an approach that allowed us to recognize common data points and drastically reduced the number of eCRFs. We simultaneously assigned experienced data management resources to clean the data that had been received to date so that it could be used for analysis and the trial could continue.

Our team then integrated the data from each of the three protocols, and legacy data from their previous programs, utilizing our proprietary platform, elluminate® to aggregate and analyze the study results. We worked with the team to develop a series of custom reports and visualizations that would address their review and monitoring needs.

Results
Today, the sponsor team now has access to all of their data and are able to analyze critical details including disease progression, tumor response rate, lesion measure over time and survival details through the custom reports and visualizations at the click of a button without requiring internal or external resources to configure these views. Our overall end to end solution supports their decision making process and allows for more rapid insights and decisions.

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