Project Zero Delay Speeds Up Clinical Trials

3 August 2009 (Last Updated August 3rd, 2009 18:30)

Project Zero Delay, a joint effort by the Texas M D Anderson Cancer Center and pharmaceutical company AstraZeneca, has already begun to bear fruit after a clinical trial enrolled its first patient just two days after receiving drug approval. The project, a strategic collaboration to accel

Project Zero Delay, a joint effort by the Texas M D Anderson Cancer Center and pharmaceutical company AstraZeneca, has already begun to bear fruit after a clinical trial enrolled its first patient just two days after receiving drug approval.

The project, a strategic collaboration to accelerate the development of a new cancer drug, managed to kick off trials a full three to six months sooner than is the norm for a process that could take up to 12 years.

M D Anderson vice-president for translational research Robert Bast said it is necessary 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," Bast said.

The time between receiving a written protocol approving the new drug and patient enrolment is typically 135 days. Zero Delay managed complete written protocol to first patient in 46 days, after receiving US Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application on day 44.

According to the company, the key to the project is performing most tasks in parallel instead of sequentially. In addition, tasks usually done after FDA clearance of an IND application were instead done in advance, without skipping any administrative steps.

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.