The board of St Vincent's Healthcare Group has denied that it turned down or delayed trials on a new breast cancer drug on the grounds that the trials required women to use contraception.
The board of St Vincent's Healthcare Group has denied that it turned down or delayed trials on a new breast cancer drug on the grounds that the trials required women to use contraception
Consultant oncologist Prof John Crown claimed earlier this month the Ethics and Medical Research Committee at St Vincent's raised concerns about a trial for which he sought approval because women taking part would have to use contraception.
If women became pregnant while on the drug, Tarceva, the effect on their baby could be catastrophic.
However, Dr Crown said the trial eventually went ahead after he protested. But the Board of St Vincent's today issued a statement dismissing the claims.
"The Ethics and Medical Research Committee of the St Vincent's Healthcare Group wishes to state in the clearest way that no clinical trial or study has been turned down or delayed due to the contraceptive advice or guidelines contained in the applications," it said.
The statement said many trials and studies require the women involved to use contraception and the ethics committee's policy is to advise women to do so.
"The Ethics Committee has maintained and continues to maintain that the form of contraception is a matter to be decided by both the patient and the principal investigator, as appropriate to the individual," the statement said.
The Board insisted it has, at all times, complied with regulations on medical trials as set out by the Department of Health and Children.