Ill patients should play a greater role in early clinical trials to prevent a recurrence of the fiasco that left six healthy men seriously ill, experts said yesterday.
A working group set up to examine clinical trials in the wake of the Northwick Park fiasco said patients needing treatment should potentially be used to greater effect in phase one tests, especially if the drug has an effect on the immune system. At present, this stage relies mostly on healthy volunteers, with ill patients taking part only occasionally.
Under the new raft of proposals, which are open to consultation, the sick would be considered instead of there always being an "assumption" that healthy volunteers are used.
Six men fell ill during the disastrous trial in March after being injected with TGN1412, a drug designed to treat rheumatoid arthritis, leukaemia and multiple sclerosis.
Their heads and bodies rapidly swelled up soon after they were injected.
Lawyers for those taken ill at Northwick Park criticised the way all six men were given the drug at the same time rather than individually with time to gauge the effects.
Yesterday's report said that during drug trials of this type, the first dose should be given to one person only to better assess the risks involved.