UK report recommends better Ph I trial planning

The Royal Statistical Society has published a report analyzing the procedures for Phase I clinical trials in the UK, following the TGN 1412 incident last year (Marketletters passim). The main finding is that "more careful planning" should be exercized. The fact that six volunteers experienced adverse effects, the RSS argues, indicates that the trial's design "might have been deficient."

Stephen Senn, the working party's chairman, said that many early trials lack clear aims. He told the British Medical Journal that "researchers are uncertain about what they are going to find, so they don't document in detail the study design or how they will analyze what they find."