Pfizer ($PFE) and Roche ($RHHBY) are the latest pharma heavyweights to join Icon's ($ICLR) consortium of drugmakers working to flesh out new technology for adaptive clinical trials, allowing study sponsors to react to results in real time and maximize efficacy.
The group--which also includes Novartis ($NVS), Johnson & Johnson's ($JNJ) Janssen unit and Eli Lilly ($LLY)--is collaborating to improve dose selection in Phase III trials, a common hurdle that can derail development.
Icon bought its way into the consortium with its $143.5 million acquisition of Aptiv Solutions earlier this year, and that company's adaptive trial software is key to the collaboration. Using Aptiv's AddPlan technology, the group is working to expand dose-finding methodology from proof of concept studies to mid-trial decision making, potentially making late-stage trials more flexible and efficient, Icon said.
"The membership of Pfizer and Roche, long time proponents of adaptive design, significantly strengthens the consortium's ability to develop validated, regulatory-compliant software for the design and execution of adaptive trials," Executive Vice President Reinhard Eisebitt said in a statement.
The dose-selection effort focuses on one of four AddPlan modules, which include applications for sequential trial design, comparison procedures and population enrichment, the company said.
Beyond the Aptiv acquisition, Icon has been deepening its offerings in adaptive trials over the past year, unveiling service platforms that allow sponsors to detect safety issues, keep tabs on sites, and track and visualize efficacy trends in real time. Meanwhile, risk-based trial monitoring has continued to win favor from Big Pharma and regulators alike, a boon to large CROs that can afford the technology's upfront cost--including Icon, Quintiles ($Q) and PRA.
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