Phase I Trials Take on Greater Budgetary Importance


Applied Clinical Trials

Phase I clinical trials are outsourced almost as equally as Phase III (58% vs. 54% respectively), and based on Oracle Health Sciences’ conversations with customers, those numbers still ring true. However, the need for Phase I planning, forecasting, sourcing and tracking capabilities has become even more important to pharmaceutical companies and CROs.

Andy Grygiel, Senior Director, Health Sciences Product Strategy at Oracle, spoke to Applied Clinical Trials about its new version of its cloud-based ClearTrial Plan and Source software, which features these enhanced Phase I capabilities. “When ClearTrial was developed, it was focused more on the Phase II-IV trials, those that are more expensive.” But in more recent years, customers have asked for portfolio capabilities, to examine costs across the whole trial. “When we introduced that capability, and combined that with an increased focus on budgets, customers wanted to include Phase I trials so they could look at the portfolio across the entire spend, or the spend across a therapeutic area,” explained Grygiel.

For more information on the costs and budget needs currently faced by sponsors, click here.

Grygiel described the Oracle ClearTrial software’s “heart and soul” is its a work breakdown structure. That structure includes labor costs, pass-through costs, who does what work, billing hours, etc., for the specific trial phases. “The work breakdown structure is sensitive to phase, indication, where a trial is being run, the therapeutic area,” and more, explained Grygiel. Initially, when developing the Phase I work breakdown structure, the Oracle team considered it a modification from its existing phase structures. However, they quickly found out that the inherent differences of Phase I trials—more controlled environment, not global, PK/PD information--influenced what design-specific modifications were included in the software. To that end, there are no changes to the look, feel and function from a user standpoint. “Essentially, we added a new work breakdown structure that is seamlessly integrated,” said Grygiel.

In addition to the needs for a more accurate planning and forecasting Phase I tool, the Oracle ClearTrial team also noted an increase in complex trials, such as mutli-arm and cross-over trials, that add costs. The new software version addresses those needs by capture accurately the costs and resources.
The changes to the Plan part of the software suite, which allows for the more accurate and detailed planning, as well as quick hit cost ballparking, in the complex and Phase I trials, then goes to the next suite software piece, Source. Source is where the outsourcing piece takes more precedence as it allows companies to determine what to outsource and create the RFP. It allows CROs and sponsors to compare apples to apples in the outsourcing agreement.

Oracle Health Sciences acquired ClearTrial end of March 2012.


Related Links:
Increasing Planning Efficiency in Clinical Development

Effective Resource Planning: Reducing Clinical Project Risk and Operating Cost

How Effective Resource Planning Reduces Study Cost and Risk


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