Clinical Trials

The role of the Irish Medicines Board is to assess applications from sponsors to conduct clinical trials with medicinal products. The types of trials assessed range from first-in-man studies for new compounds to studies with products which already have marketing authorisations.

Clinical trials are undertaken to allow data on the safety and efficacy of new products to be collected.   These trials can be conducted using healthy volunteers or patients, depending on the type of product and its stage of development.   Information on the quality of the product and its non-clinical safety will have been obtained before the clinical trial programme commences.

Clinical trials begin with small studies in a controlled population of volunteers or patients and, as data are gathered, expand to large scale studies in patients.   These large scale studies will often investigate the new product and the currently used treatment to see how these two compare.   As information is obtained, larger numbers of patients are exposed to the new product and safety data can be collected showing the safety of the product in the intended patient population.

Submission of Academic Clinical Trial Investigation Applications
When submitting academic led clinical trial investigations in circumstances where there is no financial support for the conduct of the clinical trial, the investigator may be entitled to a fee waiver.
This request must be clearly stated in the covering letter, failure to do so will result in the standard fee being charged.

Please view the Volume 10 of the Notice to Applicants for further information.

For further information, please review our Frequently Asked Questions to the right of your screen or contact the following:-

Clinical Trials Unit,
Irish Medicines Board,
Kevin O'Malley House,
Earlsfort Centre,
Earlsfort Terrace,
Dublin 2,
Ireland.

Tel: +353-1-6764971
Fax: +353-1-16768490

e-mail Clinical.Trials@imb.ie

The Irish Medicines Board - www.imb.ie

Clinical Trials