Nordic Trial Alliance Projects 2014-2015
WP1 - Work Package on Ethics - ethical evaluation of clinical trials
NRI Conference 2015, 4. May at 18:00, Scandic Ørnen Hotel
An Invitation for Discusson of the Draft Report
The project aims at fostering harmonization of the legal basis and practices of ethical review of clinical trials in the Nordic countries. The European Parliament and the Council of the European Union have on April 16th, 2014 approved the new EU Regulation No 536/2014 on clinical trials on medicinal products for human use, repealing the Directive 2001/20/EC. The new Regulation calls for changes in the current legislation and practices of the ethical review of clinical trials. This creates a unique opportunity for the Nordic countries to jointly reform their procedures for the ethical evaluation of clinical trials, in order to have fully harmonized systems that provide competitive advantages and a basis for improved Nordic collaboration. The aim of NTA’s WP1 is to map these possibilities and to suggest solutions for a harmonized Nordic system of ethical evaluation of clinical trials.
The work in WP1 was started at NTA Stakeholders’ meeting in January 2014. A joint workshop was held in Helsinki on October 9th, 2014 with 50 participants representing all five countries. The workshop discussed various alternative strategies to deal with the necessary changes in legislation and procedures, and concluded that this chance to harmonize the ethical review in the Nordic countries must be used. The workshop’s materials have been uploaded to the website of the National Committee on Medical Research Ethics in Finland (TUKIJA) at the following address: http://www.tukija.fi/en/publications/seminars/091014.
Another NTA Stakeholders’ meeting was held in Helsinki in January 2015. The meeting provided a forum for important debate. Suggestions for the future were made and discussed. After the meeting, a new draft version of the project report was created. It mapped the current procedures and suggested joint Nordic guidelines and templates.
NTA’s WP1 now wants to take the opportunity all stakeholders to discuss the suggestions and future actions with regard to the harmonization of the ethical review processes in the Nordic countries. The draft report is available for commenting, and a discussion will be held in connection with the NRI conference 2015 in Bergen, Norway. We wish to see as many stakeholders as possible in the meeting in order to continue the debate on the matter. All inquiries and requests for the draft report could be sent to our contact person.
Professor of Pharmacology
University of Turku
Turku University Hospital