When a large multinational client asked Covance to conduct a Phase III trial on a promising new colorectal cancer drug, their rigorous patient selection criteria initially caused some concern. How long would it take to identify, recruit and retain sufficient qualifying patients? After all, a recent study published by the Tufts Center found that, although 90% of clinical trials worldwide meet their patient enrollment targets, the trade off is that drug developers typically need to nearly double their original timelines to reach those targets.*
However, using the wealth of past and current clinical data available through the Xcellerate® knowledge base and data-driven approach, Covance determined new patient numbers and locations quickly and managed to accurately forecast monthly recruitment. Guided by experience, they also adapted to increased interest to ensure adequate monitoring and drug supplies. Recruitment was completed 9 months early.
Anticipating and addressing any potential risks or delays along the way would also prove crucial. With the Xcellerate® predictive data management tool, Covance was able to manage data processing efficiently, predict key study endpoints based on actual recruitment and, as a result, provide timely data cleaning and interim analyses. Medical monitors reviewed patient safety and feedback, thus making for high quality, meaningful reporting.
To support forecasting and speedy data delivery further, teams held regular process review meetings, proactively suggested data handling efficiencies and recommended cost-effective solutions to the client, minimizing delays that would have a negative impact on both trial costs and future drug profitability.
Covance Xcellerate® Clinical Trial Optimization® Case Study
Find out in more detail how the predictive power of Covance Xcellerate® – a more strategic approach to Clinical Trial Optimization® – enabled teams to manage the trial in a proactive and preventative manner, while generating a high level of trust, collaboration and risk-sharing with the client. By combining accurate forecasting with robust project and data management, teamwork and communication, Covance delivered the study more than a year ahead of schedule, saving the client time and money.
* Source: article by Ryan McBride, published on FierceBiotech, January 15, 2013