Dáil Éireann debate -
Thursday, 13 Feb 1992

Vol. 415 No. 7

Written Answers. - Clinical Trials.

Bernard Allen

Question:

99 Mr. Allen asked the Minister for Health if he will take steps (a) to ensure that data collected from clinical trials is validated for accuracy and reliability and (b) to set up a form of independent monitoring of clinical trials especially in view of recent revelations of misleading results being reported from some trials.

Minister for Health (Dr. O'Connell)

Controls for the conduct of clinical trials are laid down in the Control of Clinical Trials Acts, 1987 and 1990. Permission for trials under these Acts are issued by the Minister for Health on the advice of the National Drugs Advisory Board.

As regards applications for product authorisations under the Medical Preparations (Licensing, Advertisment and Sale) Regulations 1984-89, the position is that data collected from clinical trials usually forms part of the information submitted in the applications. It is a function of the National Drugs Advisory Board to ensue that the data presented is validated for accuracy and reliability in its examination of the product authorisation application.

In view of the role and function of the National Drugs Advisory Board and their recognised independence from the pharmaceutical industry, I do not consider that there is any need to set up another independent form of monitoring the results of these trials.