BMJ  2007;334:551 (17 March), doi:10.1136/bmj.39153.352234.DB

News

UK report recommends better planning for phase I drug trials

Susan Mayor

London

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

The first trials of new drugs in humans should be planned much more carefully, with the same clarity of purpose, design, and analysis as for studies supporting drug licensing, a report published this week recommends.

The report, published by a working party of the Royal Statistical Society, was prompted by the TGN1412 drug trial last year in which six healthy volunteers experienced severe immune reactions (BMJ 2005;332:683, doi: 10.1136/bmj.332.7543.683). It found that "the trial design was not well suited to its objectives of testing the safety and tolerability of the drug."

Stephen Senn, professor of statistics at the University of Glasgow and chairman of the working party, said, "The fact that so many volunteers simultaneously suffered severe reactions clearly signalled that the design of the TGN1412 trial might have been deficient."

He considered that many early phase studies lack clear aims or plans for analysis. "Researchers are uncertain . . . [Full text of this article]


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Severe adverse reactions prompt call for trial design changes
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