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Dáil Éireann díospóireacht -
Tuesday, 30 Jan 2001

Vol. 529 No. 1

Written Answers. - Clinical Trials.

Dan Neville

Ceist:

712 Mr. Neville asked the Minister for Health and Children the number of clinical trials approved during the years 1968 to 1997 inclusive, in patients with psychiatric illness. [2207/01]

Prior to the introduction of the Clinical Trials Act, 1987, a voluntary scheme of control only existed. Under the Act, all clinical trials conducted in Ireland required approval by the National Drugs Advisory Board, now the Irish Medicines Board, and the appropriate ethics committee.

Records of clinical trial approvals were not computerised by the board until 1996. The board has advised me, therefore, that although the information concerning the numbers of trials approved since 1996 can be readily obtained the information for the earlier years will have to be extracted from archived material. As this entails examining each clinical trial file in the archives the collation of the information will inevitably take some time.

I have asked the Irish Medicines Board to commence this examination and to let me have the information requested by the Deputy as early as possible. I will forward this information to the Deputy as soon as I receive it from the board.

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