European Medicines Agency - Regulatory - Regulation of medicines

D - Description



  Description

Name

OKIDS - Medicines for Children Research Organization Austria

Year of foundation OKIDS was established in 2012; Network hubs (Universities and Hospitals sites and respective investigators) all have a long standing history of clinical research activity over more than 30 years which has been merged within the OKIDS network.
Preterm and/or term newborn Yes
Infants from 1 month to less than 24 months of age Yes
Children from 2 years to less than 12 years of age Yes
Adolescents from 12 years to less than 18 years Yes
Paediatric age ranges of study participants covered by the network 0-18 years, young adults
Multispeciality? Specify endocrinology, gastroenterology, haemato-oncology, haemostaseology,infectious diseases, cardiology, neonatology & intensive care, nephrology, neuropaediatrics, dermatology, immunology, palliative care, pneumology & allergology, rheumatology, metabolic diseases, general peadiatrics
Speciality/disease specific? Specify no
Conditions covered? Specify wide range of conditions within specialities: Active ulcerative Colitis Acute vein thrombosis Arterial Hypertension Asthma Atopic dermatitis Attention deficit hyperactivity disorder Atypical haemolytic uraemic syndrome Cholestasis Coagulation Cystic Fibrosis Diabetes Epilepsy Familiar Hypercholeserolemia Haemophilia A Haemophilia B Hepatitis C Immundeficiency diseases Influenza Juvenile Idiopathic Arthritis Morbus Fabri Morbus Gaucher Morbus Hunter Neonatology Obesity Oncology ** Paediatric coeliac disease Phenylketonuria PKU Postoperative pain "PPH persistent pulmonary hypertension of the newborn " Primary pulmonary Hypertension Pulmonary arterial Hypertension RSV Tuberous sclerosis Type 1 Diabetes Type 2 Diabetes Ulcerative Colitis Vein thrombosis/ Venous Thromboembolism ** Oncology: Detailed oncology conditions: Acute Leukaemia bilineary (bil. AL) Acute Lymphoblastic Leukaemia (ALL) Acute Myeloid Leukaemia (AML) Acute undiffentiated Leukemia (AUL) Chronic Myeloid Leukaemia (CML) Ewing sarcoma Fanconi Anaemia Ganglioneuroblastom Ganglioneurom Hemophagocytic Lymphohistiocytosis (HLH) Hodgkin Lymphoma (M.Hodgkin) Intrahepatale Raumforderung Juvenile Myelomonocytic Leukaemia (JMML) Langerhans Cell Histiocytosis (LCH) Liver tumour Malignant Germ Cell Tumour (GCT) Medulloblastoma Myelodysplastic Syndrome (MDS) Nasopharyngeal Carcinoma Nephroblastoma (Wilms tumour) Neuroblastoma Non-Hodgkin Lymphoma (NHL) Osteosarcoma Other Malignancy Retinoblastoma Soft tissue sarcoma TMD schwere aplastische Anämie (SAA)
Procedure/Intervention specific? Specify i.e. stem cell transplantation related trials covered within the network
Number of collaborating countries 1
List of collaborating countries part of the specialty networks run academic international trials in Europe and as well outside of Europe with up to 25 participating countries in individual trials
Number of collaborating centres 5
List of collaborating centres Main network partners within OKIDS: Clinical Research Center Salzburg GmbH, Coordination Center for Clinical Trials - Medical University of Graz, Coordinating Center for Clinical Trials - Medical University of Innsbruck Department of Pediatrics - Medical University of Vienna, Studies and Statistics at St. Anna Children´s Cancer Research Institute in collaboration with the St. Anna Children's Hospital Each of these centres has collaborations with surrounding hospitals and paediatric private practices in Austria ; In addition some of the sites run large scale international trials collaborating individually with more than 200 hospital sites internationally. According to EU legislation these institutes/universities also have taken on the role of an academic international sponsor
Type of activity/studies OKIDS is a paediatric network fostering drug development in Austria. It consists of a network of paediatric academic centres experienced in performing clinical trials on medicines for children.In addition it's partners run academic phase 1, 2 and 3 trials in different speciality aereas.
Clinical Studies Yes
Experimental research Yes
Other activity Paving the way for clinical trials on demands for industry and CROs by running country and sites feasability checks, support in the preparation of clinical trial protocols and relevant documents including informed consent as required for specifie age classes, facilitation of timely study contract management, support of clinical trials management with qualified personnal at operational study sites including in particular study nurse support. Reach out to members of the Austrian Society of Paedriatrics and Adolescent Medicine (ÖGKJ), i.e. via questionnaires, to explore medical needs and to adress drug development related questions raised by pharmaceutical industry.