Letter: Medicine needs `guinea-pigs'

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Your article about the clinical trial of CNEP (continuous negative extrathoracic pressure) in premature babies poses disturbing questions about the ethics and nature of informed consent ("Parents say `guinea-pig' trial killed their babies", 11 May).

I am a clinical trials co-ordinator in a London hospital. We conduct trials according to the Good Clinical Practice Guidelines of the EU and in accordance with the Declaration of Helsinki. Patients are presented with all the information about the study drugs, including side-effects, in laymans language, and the guidelines stipulate that they must be told how they will be compensated if they suffer injury as a result of participation. Patients are usually given at least 24 hours to decide whether to participate, and are told that their future care and treatment will not be prejudiced if they refuse. Patients are not recruited if their illness requires emergency treatment and we are hesitant if their distress would delay their decision so as to cause a worsening of their condition. Where patients choose not to take part they are offered the best proven treatment for their condition.

From your article this does not appear to have been the case with the CNEP babies. Medical research cannot advance in the absence of clinical trials and the controversy surrounding the CNEP case serves only to make people suspicious of any research, rather than commonsensically cautious. People do have rights in respect of medical treatment, and particularly in respect of clinical trials. What is lacking is education about these.

Sue Vogel, Bedford

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