Project Zero Delay Accelerates Start of Phase I Clinical Trials

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A Phase I clinical trial enrolled its first patient only two days after U.S. Food and Drug Administration clearance of the experimental drug for a first-in-human cancer trial -- a milestone that normally takes 3-6 months.

Investigators from M. D. Anderson and pharmaceutical company AstraZeneca have reported their work in the Journal of Clinical Oncology

The joint effort, dubbed Project Zero Delay, is part of a strategic collaboration between the two organizations designed to safely accelerate development of new cancer drugs. In many cases that process takes about 12 years, and the cost of bringing a new drug to patients has been estimated at around $1.3 billion.

"Project Zero Delay demonstrates how we can shrink the time it takes to bring new drugs to cancer patients," says Robert Bast Jr., M.D., vice president for translational research at M. D. Anderson and the paper's senior author. "We need to find out as promptly as possible whether new therapies will help. Zero Delay is a significant step in that direction. Close cooperation allowed us to eliminate unnecessary delays, while fully meeting regulatory requirements for scientific and human safety review."

The key to Zero Delay was performing most tasks in parallel instead of sequentially, according to Razelle Kurzrock, M.D., professor and chair of M. D. Anderson's Department of Investigational Therapeutics. In addition, tasks usually completed after FDA clearance of an investigational new drug (IND) application were instead done in advance. No administrative steps were skipped.

This approach can be applied in other areas of drug development and by other institutions willing to closely cooperate, the authors note.

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