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Drugs (Studies)

Volume 83: debated on Thursday 25 July 1985

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asked the Secretary of State for Social Services if he will request the Committee on Safety of Medicines to require investigations into light relatedness in toxicity studies on drugs.

The guidelines on the pre-clinical and clinical testing of medicinal products are drawn up on the advice of the Committee on Safety of Medicines. The committee has not advised that this should be a requirement. The occurrence of a rash, including one induced by light sensitivity, in a clinical trial would be reported in the results and would be taken into account by the Committee in its evaluation of the product.

asked the Secretary of State for Social Services (1) if he will request the Committee on Safety of Medicines to ensure that all tests of significance produced by manufacturers' statisticians in clinical trials of drugs are automatically checked by the committee's statisticians;

(2) in what ways the Committee on Safety of Medicine checks the validity of the results obtained from drug clinical trials.

I refer the right hon. Member to my reply to my hon. Friend, the Member for Chislehurst on 29 January at columns 161–2. In assessing the evidence in particular cases, the committee, having received an assessment from its professional secretariat, decides whether tests of statistical significance need to be checked before it gives its advice to the Licensing Authority.