Clinical trial of cancer drug deferred

The ethics committee at the Mater hospital in Dublin last week deferred approval of a clinical trial of a new drug for patients with lung cancer on foot of reservations about a requirement that those involved use contraception.

The trial of the drug, Tarceva - a new targeted anti-cancer treatment manufactured by Roche Pharmaceuticals which is designed to have lower toxicity than conventional chemotherapy - is being carried out at several hospitals around the State as part of an international study.

Clinicians have maintained that the drug shows promise for patients with forms of lung cancer. The trial had been approved by the Irish Medicines Board and the ethics committee at Tallaght hospital in recent months.

Under new legislation, once a trial is approved at one of a number of centres around the State, it is considered to have approval nationwide.

However, when the trial was submitted to the ethics committee at the Mater hospital last week, it is understood that there were concerns about the requirement set out in the governing protocol and the information leaflet for patients that those involved should use contraception while receiving the drug.

It is understood that the ethics committee deferred a decision on the application for approval of the trial at the hospital.

A spokesman for the Mater last night declined to comment on the issue of the clinical trial. Oncologists yesterday said that internationally it was considered that patients receiving chemotherapy or treatment for cancer should not become pregnant.

Informed sources said that under previous legislation when trials had to go before individual hospital ethics committees that references to contraception had to be excised from protocols and patient information leaflets submitted to the Mater so that they did not offend the ethos policy.

Sources said that this policy meant that the process of securing ethical approval for clinical trials for some drugs in the Mater was much slower than in other institutions.

It is understood the Department of Health has been made aware in recent days of the decision by the ethics committee at the Mater to defer a decision on the clinical trial of the lung cancer drug.

According to some informed sources, moves will be made later this week to look again at the clinical trial of Tarceva at the Mater.

Some sources said this could involve the introduction of a new system of freedom of choice to allow patients specifically to opt in or out of clinical trials involving a requirement for contraception.

It is understood the Irish Medicines Board, the regulatory body for drugs and medicines in Ireland, last week approved a licence for the regular use of Tarceva on patients in hospitals here.