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Clinical Trials in Ireland

Notice type: 3rd Party Publications

Date: 30/06/2006

     

Product name or type:
Clinical Trials in Ireland MIMS Advisory

Reference:
MIMS Publication June 2006

Problem Or Issue:
Clinical trials in Ireland are regulated by the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004 [S.I. 190 of 2004]. These regulations transposed into Irish law EU Council Directive 2001/20/EC relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use and supersede the Control of Clinical Trials Act 1987, as amended. 

In addition to harmonisation of the regulation of clinical trials in Europe, Directive 2001/20/EC has facilitated the establishment of a clinical trial database that allows for the collection of information pertaining to clinical trials conducted in one or more Member States and facilitates exchange of information between the competent authorities in the Member States. 

Definition of a Clinical Trial: 

In accordance with current legislation a clinical trial is defined as:
 
‘any investigation in human subjects, other than a non-interventional clinical trial, intended 

(a) to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more investigational medicinal products, or 

(b) to identify any adverse reactions to one or more such investigational medicinal products, or 

(c) to study absorption, distribution, metabolism and excretion of one or more such investigational medicinal products, or 

(d) to discover, verify, identify or study any combination of the matters above 

with the object of generating data on the safety and/or efficacy of a medicinal product’. 

Categories of Clinical Trials: 

There are four categories of clinical trials, which may be described as follows: 

Phase I: Initial trials carried out to determine the metabolism and pharmacological actions of medicinal products in humans, the most commonly occurring adverse reactions associated with increasing doses, and to gain early evidence of effectiveness. These studies may include healthy participants and/or patients. 

Phase II: Controlled clinical trials conducted to evaluate the effectiveness of the medicinal product for a particular indication in patients with the disease or condition under study and to further determine the common adverse reactions and risks associated with the product. 

Phase III: Expanded controlled and uncontrolled clinical trials after preliminary evidence suggesting effectiveness of the medicinal product has been obtained. These studies are intended to gather additional information to evaluate the overall benefit-risk profile of the medicinal product and provide a basis for the product information. 

Phase IV: Clinical trials carried out following authorisation and designed to detect less commonly occurring or longer-term adverse reactions in larger patient populations and over longer periods of time than is possible during initial clinical trials. ‘Noninterventional’ Phase IV studies, i.e. those where the medicinal product is prescribed in accordance with the terms of the marketing authorisation and assignment of patients to treatment is not decided in advance by a clinical trial protocol, do not require authorisation under the above-mentioned clinical trials regulations. 

Ethics Committees 
Ethics committee approval is an integral part of the regulation of clinical trials. Prior to commencement of any clinical trial authorised by the IMB, the Sponsor [i.e. organisation or person responsible for the initiation and management of the trial] must also obtain approval from a recognised Ethics Committee. The recognition and supervision of ethics committees fall under the remit of the Department of Health and Children. 

Background Information Or Related Documents:
Clinical Trials in Ireland Document

Further Information:
Further information is available from the HPRA website at www.hpra.ie

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