UK report recommends better planning for phase I drug trials

doi:10.1136/bmj.39153.352234.DB

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Susan Mayor

London

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 …