The group established to make recommendations on improving the safety of phase 1 clinical trials, today published its final report at the Science Media Centre in London.
The independent Expert Scientific Group (ESG) was convened by the Secretary of State for Health to examine trials involving new types of drugs, following adverse reactions experienced by participants in the clinical trial of the drug known as 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 first-in-man clinical trials.
They cover a number of key areas:
- the 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-information about unpublished clinical trials and adverse reactions occurring in trials.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
- the location of trial units and the provision of adequate medical back up in case of problems arising.
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