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Regulatory Focus™ > News Articles > Quality & Compliance: Research Subject Safety Series Part 1: A First-in-Man Phase 1 Clinical Trial:

Quality & Compliance: Research Subject Safety Series Part 1: A First-in-Man Phase 1 Clinical Trial: A Tragic Ending leads to a New Guideline

Posted 01 April 2008 | By

The injury of six healthy volunteer research subjects during a first-in-man phase 1 clinical trial at Northwick Park research center in 2006 sent shock waves throughout the pharmaceutical community and the general public worldwide. Many people, including those involved in the drug development process and clinical research, believed something was clearly amiss with the system for assessing clinical trials if this type of event could occur. Answers were demanded about what went wrong and what would need to change in the way clinical trials are conducted. In the aftermath of this event, there was an extensive investigation and report,1 and a new guideline2 was issued. Scientists have discussed at length the physiological and scientific issues involved.1,3,5 Project teams working on New Chemical Entities can learn important lessons from reviews and investigations of this event.1

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