Austrian research network for pharmaceutical research (OKids). General framework, goals and European perspective

作者：Ladenstein R^*; Lagler F; Pleiner Duxneuner J; Embacher S; Pfaffenthaler G; Male C; Kerbl R

来源：Monatsschrift Kinderheilkunde, 2013, 161(4): 316-324.

DOI：10.1007/s00112-012-2792-4

• Drug evaluation
• One stop shop
• Research network
• Children
• Adolescents

When the Paediatric Regulation (Regulation (EC) No. 1901/2006) went into effect in January 2007 a clear signal was sent to the European Member States that the dilemma of medicinal drugs for children and young people needs to be solved in spite of the ethical reservations to perform clinical trials in minors. Since 2008, there is the obligation to run clinical trials with children in Europe. %26lt;br%26gt;In Austria the Ministry of Health initiated a dialogue on Children%26apos;s Health Issues in 2010 by establishing a working group with stakeholders from politics, regulators, pharmaceutical industry, heads of the university-based coordinating clinical trial units and academic experts to define prerequisites, goals as well as duties and responsibilities for a platform in Austria to foster clinical trials and drug development with and for children and young people. The Austrian Society for Care in Children and Adolescents (A-GKJ) founded the paediatric research network O.K.ids as an Austrian contribution to solve the deficit of approved medicinal drugs for children. An analysis was undertaken on academic and industry-sponsored clinical trials run in Austria in age groups up to 18 years over a period of 5 years to generate baseline data of the current situation and as a reference for the expected future developments.

• 出版日期2013-4