THREE MEN who volunteered for a clinical drugs trial in Cork were admitted to hospital yesterday after experiencing seizures.
The three men were part of a group of 12 who were taking part in the trial at the Shandon Clinic in Cork city.
The volunteers were treated in the clinic before being transferred to Cork University Hospital accompanied by one of the doctors who was supervising the trial.
It is understood that the other volunteers incurred minor adverse reactions to the drug which included nausea, light-headedness and muscle spasms.
The trial, involving healthy males, was for a drug normally taken by cancer patients.
Although due to be completed next week, the trial has now been terminated as a precautionary measure.
The incident was reported to the Irish Medicines Board and the Clinical Research Ethics Committee of the Cork Teaching Hospitals.
In a statement last night the Irish Medicines Board said a full investigation into the Phase 1 trial was now under way.
“The trial in question was to determine the bioavailability of a drug for its potential use in the treatment of cancer and was terminated due to adverse effects on some of the volunteers.
“There are no other ongoing trials in Ireland with this investigational medicine,” the statement read.
A spokeswoman for the HSE South confirmed that three ambulances, two rapid response vehicles and two advance paramedics were called to the Shandon Clinic yesterday morning arising from the incident.
She said all three men were in a stable condition last night.
A second doctor remained at the clinic to attend to a further nine patients who remain at the Shandon Clinic for observation.
The Shandon Clinic has been in operation since 1990 and between 20 and 30 clinical trials are carried out on-site every year. The clinic is operated in the former University Dental Hospital in Cork.
In addition to a general ward, there are facilities for clinical pharmacology studies in which intensive monitoring of subjects may be required.
The Shandon Clinic conducts clinical studies in healthy volunteers on behalf of pharmaceutical companies. These include pharmacokinetic studies, dermatology studies, and oral soft tissue studies.
Volunteers are remunerated 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 some 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 Irish Medicines Board and an independent ethics committee.
Studies are governed by principles laid down in the Declaration of Helsinki, an internationally recognised document that sets standards for the conduct of clinical research. In addition studies are subject to the European Clinical Trials Directive.
The unit at the Shandon Clinic includes 18 beds, an outpatient clinic, a dental unit and a pharmacy.