Probe ordered as drug trial trio sent to hospital
Published 28/08/2010 | 05:00
Three volunteers who became ill after taking part in a private clinic's drug trial were under observation in hospital last night.
An investigation is now under way into the trial at the Shandon Clinic in Cork where the male volunteers were testing a potential cancer treatment. However, they were admitted as patients to Cork University Hospital yesterday morning after they developed adverse reactions to the drug and the trial was halted. Nine other volunteers are being cared for at the clinic.
The trial in question was to determine whether the drug could be used in the treatment of cancer.
The Irish Medicines Board (IMB) confirmed last night that a full investigation into the trial had started. This will examine how procedures and safety precautions were followed.
A clinic spokeswoman said: "The three people affected by the medication are in a stable condition. I understand the nine other volunteers will stay at the clinic under medical supervision as a precaution. But they may well have been staying (at the clinic) anyway under the terms of the trial."
The spokeswoman also confirmed that three ambulances, two rapid response vehicles and two advance paramedics were called to the Shandon Clinic yesterday morning in response to the incident.
The Shandon Clinic conducts clinical studies on behalf of pharmaceutical companies.
Volunteers are paid at a rate of €130 a day or €20 per short visit. The total amount paid in each study varies depending on the requirement of each study. Participants may withdraw from any study at any stage.
Prior to signing up for any trial, volunteers have to read information about the study in which they plan to participate. They also have to inform the clinic of the name of their GP and are given appointments for full medical screenings.
Each study protocol has been reviewed by the IMB and an independent ethics committee.
The ill volunteers were accompanied to hospital by one of the doctors who was supervising the trial. A second doctor remained at the clinic to attend to the patients who incurred minor adverse reactions to the drug. It is understood the cancer drug trial was due to be completed next week. However, it has been terminated as a precautionary measure.
The incident has been reported to the IMB and the Clinical Research Ethics Committee of the Cork Teaching Hospitals in accordance with legal requirements.