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07/12/2006
Experts deliver clinical trial report
The expert group established to make recommendations on improving the safety of clinical drug trials has published its final report today.
During the recent trials of a drug six volunteers were made seriously ill and the independent Expert Scientific Group (ESG) was convened by the Secretary of State for Health to examine trials involving new types of drugs.
The report aims to prevent cases such as the adverse reactions experienced by volunteers to the experimental drug called TGN1412 earlier this year.
The ESG made twenty-two recommendations, which are expected to have far-reaching implications for those involved in the conduct and safety of human clinical trials.
The ESG has recommended: a need for scientific advice from independent experts before trials of high risk substances are approved; information about unpublished clinical trials and adverse reactions occurring in trials; the conduct and environment of clinical trials; the clinical trial application process; the skills and future specialist training needs of those conducting clinical trials; and the location of trial units and the provision of adequate medical back up in case of problems arising.
Professor Duff, Chair of the ESG, said: "The alarming outcome of the TGN1412 trial was unprecedented in the history of clinical trials, and we want to record our sympathy for all of the trial volunteers. Hearing about their experiences was valuable in making our recommendations, and we are grateful to the volunteers who were able to talk to us.
"There is certainly a need to develop new medicines for conditions where current treatment is inadequate but, in clinical trials, the well-being of volunteers must always come first. We believe our recommendations would safeguard this in the future."
All six men given TGN1412 suffered multiple organ failure and are in the process of launching a multi-million pound case seeking damages from the company that conducted the clinical trial.
(SP/KMcA)
During the recent trials of a drug six volunteers were made seriously ill and the independent Expert Scientific Group (ESG) was convened by the Secretary of State for Health to examine trials involving new types of drugs.
The report aims to prevent cases such as the adverse reactions experienced by volunteers to the experimental drug called TGN1412 earlier this year.
The ESG made twenty-two recommendations, which are expected to have far-reaching implications for those involved in the conduct and safety of human clinical trials.
The ESG has recommended: a need for scientific advice from independent experts before trials of high risk substances are approved; information about unpublished clinical trials and adverse reactions occurring in trials; the conduct and environment of clinical trials; the clinical trial application process; the skills and future specialist training needs of those conducting clinical trials; and the location of trial units and the provision of adequate medical back up in case of problems arising.
Professor Duff, Chair of the ESG, said: "The alarming outcome of the TGN1412 trial was unprecedented in the history of clinical trials, and we want to record our sympathy for all of the trial volunteers. Hearing about their experiences was valuable in making our recommendations, and we are grateful to the volunteers who were able to talk to us.
"There is certainly a need to develop new medicines for conditions where current treatment is inadequate but, in clinical trials, the well-being of volunteers must always come first. We believe our recommendations would safeguard this in the future."
All six men given TGN1412 suffered multiple organ failure and are in the process of launching a multi-million pound case seeking damages from the company that conducted the clinical trial.
(SP/KMcA)
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