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Project Zero Delay Accelerates Drug's Path to Clinical Trial
Date:8/3/2009

ve steps were skipped.

This approach can be applied in other areas of drug development and by other institutions willing to cooperate closely, the authors note. "Zero Delay addressed one aspect of drug development -- clinical trial start-up time," Kurzrock said. "Substantial time could be cut from other steps by applying the same principles."

The time between having a complete written protocol and enrollment of the first patient is typically 135 days in M. D. Anderson's Phase I Clinical Trial Program when processing of the protocol starts after IND approval. Zero Delay went from having a complete written protocol to first patient in 46 days, with FDA clearance of the IND on day 44. Research elsewhere cited in the Zero Delay paper indicates enrollment of the first patient after having a final protocol typically takes 3-6 months.

Administrative tasks accomplished before the FDA's ruling included budget and contract negotiations, site visits and preparation, training and a series of mandatory institutional reviews at M. D. Anderson.

"M.D. Anderson and AstraZeneca share a common goal of using leading edge science to deliver medicines that will benefit patients now and in the future, while speeding up the process and making it more cost efficient," said Alan Barge, vice president and Head of Oncology at AstraZeneca. "AZ is always looking to improve our processes and to optimize value along our pipeline. This achievement is a great example of what can be accomplished when we pair our first class internal capabilities with the strengths of one of our key alliance partners in the U.S."

In 2005, M. D. Anderson and AstraZeneca established a strategic alliance that includes a master agreement for clinical and translational/preclinical research specifying terms for standard items that can cause lengthy negotiations. The master agreement ensures that new research projects and cli
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SOURCE AstraZeneca
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