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Journal of the National Cancer Institute Advance Access originally published online on June 12, 2007
JNCI Journal of the National Cancer Institute 2007 99(12):915-917; doi:10.1093/jnci/djm033
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© Oxford University Press 2007.

NEWS

CLINICAL TRIALS GET TOUGH

Britain Adopts More Stringent Rules for Phase I Trials of High-Risk Compounds

Gunjan Sinha

The first 150 words of the full text of this article appear below.

After a disastrous phase I clinical trial last year that left six volunteers seriously injured, Britain's Medicines and Healthcare Research Agency (MHRA) has tightened its clinical trial regulations. Now studies of certain classes of drugs that have never before been tested in humans will have to follow new guidelines on a range of topics, including dosing protocols and training for investigators.

"Everyone realized that the first priority is the safety and well-being of subjects," said Gordon Duff, M.D., Ph.D., professor of molecular medicine at the University of Sheffield. "So most stakeholders were pulling in the same direction."

Duff led the expert scientific group (ESG)—an independent body of 19 people commissioned by the U.K.'s Secretary of State to investigate details of the TGN1412 trial and to recommend changes to existing procedures. The group consulted various stakeholders—both national, such as the British BioIndustry Association and the Association of the British Pharmaceutical Industry, . . . [Full Text of this Article]

The Catastrophic Trial

Improving Preclinical Research

Deciding on Dosing

Boosting Regulatory Oversight


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