Open AccessThe new EU Clinical Trials Directive and Orphan Medicinal Products: current status and recommendations
Author(s) -
Tambuyzer Erik,
Mooney Paul,
Incerti Carlo
Publication year - 2004
Publication title -
the quality assurance journal
Language(s) - English
Resource type - Journals
eISSN - 1099-1786
pISSN - 1087-8378
DOI - 10.1002/qaj.271
Subject(s) - directive , european union , clinical trial , member states , orphan drug , medicine , business , risk analysis (engineering) , political science , international trade , bioinformatics , pathology , computer science , biology , programming language
The European Union (EU) ‘Clinical Trials’ directive will be implemented in all EU member states in May 2004 and will have a significant impact on clinical research in the EU. Its advent has caused a stir amongst commercial companies and academics alike and many even argue that it should not lead to excessive administration. Its implementation should therefore be carefully coordinated to avoid stifling valuable, potentially life‐saving research. It may particularly affect trials with orphan medicinal products, in rare genetic diseases or in oncology. These can be more difficult to manage due to complex or poorly understood disease pathology and the need to involve multiple trial sites with experts in different countries. This article illustrates the complexity of such trials, contains a brief analysis of the Directive, highlights the importance of a ‘flexible’ approach to trial design and conduct and includes a list of recommendations that could accompany the implementation of the Directive. Copyright © 2004 John Wiley & Sons, Ltd.