Statement from Dr. Jorg Taubel

Posted:
16
March 2006

I want to reassure volunteers about taking part in a Phase 1 clinical trial following recent media reports of a tragedy at another hospital-based research facility. On behalf of everyone here at Richmond I would like to wish the volunteers in question a quick and full recovery; our thoughts are with them and their families.We are concerned by the events of the past few days.Clinical trials are an essential aspect of medicines development and the chances of someone suffering a fatal injury following a clinical trial are incredibly rare � we estimate that it is somewhere between one in five hundred thousand and one in one million - the same as the risk of suffering a fatal injury during a fairground ride or swimming.Every aspect of a new medicine is closely monitored during the 12 years it takes to be developed.It must undergo rigorous testing before it can be first tested in humans, after this stage the Medicines and Healthcare Products Regulatory Authority (MHRA), will conduct a thorough safety assessment and may or may not approve the use of the medicine in clinical trials. As a further precaution, the medicine can only be released for a clinical trial if it is approved by a Qualified Person (QP) in the pharmaceutical company responsible for producing the new medicine.As a further screen, an independent ethics committee examines every aspect of the trial that affects volunteers to ensure that they are fully informed of all procedures, risks and benefits.We are fully committed to conduct research which follows all the regulatory guidelines because they ensure that clinical trials are conducted safely.

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