UK experts' clinical trial report released

Just a day after the UK pharmaceutical industry issued guidelines to improve the conduct of early-stage clinical trials, which was called for after the adverse reactions experienced by participants in a study with the monoclonal antibody TGN1412 (Marketletters passim and page 13 this issue), the UK Department of Health released the interim report of its Expert Scientific Group, set up under the chairmanship of Gordon Duff, professor of molecular medicine and director of the Division of Genomic Medicine at Sheffield University.

The recommendations from the ESG were basically not dissimilar to those emanating from the drug industry's consultation, especially in terms of first dosing. One of the reasons the TGN1412 trials caused such problems was probably that all volunteers were dosed at the same time. However, it was also suggested in the ESG's report that first studies may more appropriately involve patients being treated for the disease rather than healthy volunteers. This also recommended better international sharing of information about serious adverse reactions in clinical trials and the development of specialist centers to undertake Phase I studies on higher risk agents.

The report, which is now open for consultation and can be found at www.mhra.gov.uk, also found shortfalls in the way that the US contract research company Parexel conducted the UK trials, and noted that, initially there was no contract between Parexel and the German firm TeGenero, which was developing TGN1412.