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Friday 28th October 2016

Tighter rules for drug trials

26th July 2006

30032006_GreenCell1.jpgThe Expert Scientific Group set up following the serious adverse reaction suffered by six volunteers in March after they took TGN1412, an experimental rheumatoid arthritis drug, has set out a series of guidelines to tighten up clinical trials involving novel drugs.

The main recommendation by the group was that patients taking new drugs, especially those affecting the immune system, should be dosed one at a time.  There should be a suitable interval to observe for adverse reactions before dosing other trial participants. In the TGN1412 trial volunteers were dosed simultaneously.

The report includes 22 recommendations and calls for the establishment of a database that would contain details of pre-clinical and phase one trials, sharing information on unexpected serious adverse reactions to any drugs tested in phase one.

The panel of experts, led by Professor Gordon Duff, also suggested it would be more appropriate in certain cases to test experimental drugs in patients with the disease rather than using healthy volunteers.

The advisory group found shortcomings in the way the trial was conducted by the US company responsible for the trial, Parexel. At the start of the trial there was no contract in place between TeGenero and Parexel, and only a draft contract between Parexel and the private laboratory it had hired.

The report was in line with recommendations made this week by the BioIndustry Association and the British Pharmaceutical Industry.

The Expert Group is due to publish its full results later this year.

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