Expert Scientific Group (ESG), chaired by Professor Gordon Duff publishes interim report on safety of clinical drug trials
25/07/2006
Thank you very much for all your hard work, especially as the outcome is better than expected. Can't thank you enough.
Shana, Wiltshire
An expert group brought together to examine the design of phase 1 clinical studies published its interim report today.
The Expert Scientific Group (ESG), chaired by Professor Gordon Duff was set up to look at improving the safety of clinical drug trials.
It was set up by the Secretary of State for Health, after the adverse reactions suffered by six men in the TGN1412 clinical drug trial.
Specialist clinical negligence solicitor Auriana Griffiths who represents two men most seriously injured in the TGN1412 trial, said:
"I am encouraged by the recommendations put forward by the expert group for consultation. I am pleased that the report has set out a number of very sensible and vital recommendations to help protect the safety of participants in clinical drug trials."
"In particular, I welcome the recommendations for earlier dialogue between the drug developer and regulator to enable a thorough review of safety data and testing drugs for the immune system on patients rather than healthy volunteers."
The report sets out a number of recommendations including:
The first dose to be given to one person only, leaving enough time for any adverse reaction to develop before further doses or administration to more people.
The possibility of patients being treated for the disease taking part in trials instead of healthy volunteers.
Better international sharing of information about serious adverse reactions to drugs in trials; and the development of specialist centres to undertake phase one studies on higher risk drugs.
The recommendations will now go out for consultation before a full report is published later this year.
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