Drug trial emergency trio 'stable'
Volunteers rushed to hospital as adverse reaction to cancer medication affects 12 at clinic
Published 29/08/2010 | 05:00
THREE volunteers who fell ill during a clinical drug trial in Cork last Friday remain in a stable condition at Cork University Hospital (CUH) and are set to make a full recovery.
The adverse reactions at the respected Shandon Clinic Centre in Cork occurred amidst a surge of interest in clinical trials among members of the public as unemployment rises.
Volunteers, who are mainly aged 20-25, are paid in excess of €100 a day for participating in trials.
The trial involved healthy males using a drug normally taken by cancer patients.
The volunteers were treated in the Shandon Clinic and transferred to CUH as a precautionary measure.
The men were accompanied to hospital by one of the doctors who was supervising the trial.
A second doctor remained at the clinic to attend to a further nine patients who incurred minor adverse reactions to the drug.
A spokesperson for the HSE South confirmed that the three volunteers were in a stable condition in hospital.
"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 last Friday morning arising out of the incident.
The Shandon Clinic conducts clinical studies on healthy volunteers on behalf of many major 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 requirements. 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.
The now terminated trial was to determine the bioavailability of a drug for its potential use in the treatment of cancer.