Directive has ‘chilling effect’ on cancer trials
Dr John Crown, who has overseen a number of clinical oncology trials in St Vincent’s private hospital in Dublin, said the Clinical Trials Directive, introduced in February, was having a “chilling effect.”
“It’s a disaster. We have heard companies say they are less attracted to Ireland for the purpose of sponsoring trials because we do not have ethics committees in place.”
The directive, when transposed into Irish law, required ethics committees to apply to a supervisory body for accreditation to allow them approve trials. However, Dr Crown said the committees were in a state of disarray and in some cases, had been “stood down.”
The Irish Medicines Board (IMB), to whom applications for trials must be submitted, has received just six new trial applications since the beginning of May, according to a report in the Irish Medical News.
The IMB usually reviews around 50 clinical trial protocols per quarter but some ethics committees have said they have had no serious applications for trials since the directive came in, according to Dr Brian Moulton, Chief Executive of the Irish Clinical Oncology Research Group (ICORG).
He said if the situation is still in “limbo” by September or October it could spell disaster for the future of clinical research here.
“There are still no functioning ethics committees and very little is happening in any area. A lot of companies and international agencies are adopting a ‘wait and see’ approach.”
ICORG, which has secured major international hospital-based research projects for Ireland in recent years, has asked for feedback about difficulties facing research agencies and received more than 30 emails suggesting investors were watching the Irish situation with interest “but at present there is a limbo period.”
Dr Moulton has had indications that there are a number of major international studies that could be done in Ireland if the situation was clarified, he told IMN.
Dr Crown said the Department of Health had years of notice to ensure the smooth transposition of the EU directive into Irish law. He said the current state of play meant charities wishing to sponsor academically-led clinical trials were discouraged by the legal requirements of the new directive. Large drug companies, with a commercial interest, were not put off because they had huge money and legal teams behind them.
However, charitable sponsorship of academically led trials, which would be of great value to medical research, were in jeopardy, Dr Crown said.
