Experts issue high-risk drug trial advice
High-risk drugs need to be more carefully administered, report advises
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Thursday, 07, Dec 2006 12:43
Final recommendations on how drugs should be tested have been released today in the wake of a trial which left six men seriously ill and with long-term health problems.
The independent expert scientific group (ESG), set up by the health secretary following the TGN1412 trial in north London in March, has announced 22 recommendations to ensure better scientific assessments of biologically active drugs and more stringent monitoring of how trials take place.
Among the recommendations is the need for one person to be given the drug rather than numerous people at the same time and for the dose to be administered slowly over a number of hours to allow scientists to assess whether the rate should be lowered.
The ESG also advises that some drugs may be best given to people who are already ill.
Professor Duff, chair of the ESG, said: "There is certainly a need to develop new medicines for conditions where current treatment is inadequate but, in clinical trials, the wellbeing of volunteers must always come first. We believe our recommendations would safeguard this in the future."
Commenting on the report, health minister Andy Burnham said: "We believe that implementing the wide ranging and comprehensive recommendations made in this report could make a significant contribution to improving the safety of clinical trials of high risk drugs… We will be studying them carefully."
And Aisling Burnand, chief executive of the BioIndustry Association (BIA), said: "We must remember that the TGN1412 trial was wholly exceptional, and that phase one trials have an excellent safety record. The findings from the expert review will now enable us to learn from these tragic events and enhance the protection of patients and volunteers in the future."
Some of the recommendations made in the interim report from the ESG have already been implemented by the Medicines and Healthcare products Regulatory Agency (MHRA).
Developed by German biotech company TeGenero, TGN1412 was designed to treat rheumatoid arthritis, leukaemia and multiple sclerosis.
During the phase one trials of the drug at Northwick Park hospital, the six men became ill after 90 minutes and after 12 hours all were admitted to intensive care, with two patients becoming so ill that they required intensive organ support for between eight and 16 days.
Since then they have been told that they face long-term health risks such as cancer and the worst affected man had toes and fingers amputated.