1. Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)
- Author
-
Raquel Hernandez, Hanna Johansson, Béatrice Barraud, Jane Byrne, Gabriele Dreier, Fernando de Andres-Trelles, Wolfgang Kuchinke, Siobhan Gaynor, Christine Kubiak, Arrigo Schieppati, Adeeba Asghar, Zsuzsa Temesvari, Jacques Demotes-Mainard, Charlotte Asker-Hagelberg, Gabriella Kardos, Sue Bourne, György Blaskó, Xina Grählert, Margaret Cooney, Christian Gluud, Christian Libersa, Steffen Thirstrup, Kate Whitfield, Timothy O'Brien, Nuria Sanz, Ruth Grychtol, Karl-Heinz Huemer, Jean-Marc Husson, Institut Thématique Santé Publique, Institut National de la Santé et de la Recherche Médicale (INSERM), Departemento de Farmacologia (Medicina), Universidad Complutense de Madrid = Complutense University of Madrid [Madrid] (UCM), KKS-Duesseldorf (KKSD), Heinrich Heine Universität Düsseldorf = Heinrich Heine University [Düsseldorf], Medical University of Vienna (ATCRIN), Copenhagen Trial Unit (CTU), Copenhagen University Hospital-Rigshospitalet [Copenhagen], Copenhagen University Hospital, CIC CHU ( Lille)/inserm, Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille, Droit et Santé, KKS, Medizinische Fakultät Carl Gustav Carus, ZKS - Clinical Trials Centre, University Medical Centre Freiburg, Hungarian ECRIN Committee, Ministry of Health Social and Family Affairs-Medical Research Council (HECRIN), National University of Ireland [Galway] (NUI Galway), Molecular Medicine Ireland (ICRIN), Istituto di Ricerche Farmacologiche Mario Negri (IRFMN), Hospital Clinic i Provincial de Barcelona (SCReN), Karolinska Trial Alliance, UK Clinical Research Collaboration, Education and Research Centre, Wythenshawe Hospital, UK Clinical Research Network, European Forum for Good Clinical Practice, ECRIN is a project funded by the EU Sixth and Seventh Framework Programmes., and BMC, Ed.
- Subjects
Pathology ,medicine.medical_specialty ,Biomedical Research ,Knowledge management ,MESH: Clinical Trials as Topic ,MEDLINE ,Alternative medicine ,Medicine (miscellaneous) ,030226 pharmacology & pharmacy ,03 medical and health sciences ,0302 clinical medicine ,Epidemiology ,Humans ,Medicine ,Pharmacology (medical) ,MESH: Data Collection ,030212 general & internal medicine ,GeneralLiterature_REFERENCE(e.g.,dictionaries,encyclopedias,glossaries) ,Clinical Trials as Topic ,lcsh:R5-920 ,Data collection ,MESH: Humans ,business.industry ,Data Collection ,Research ,Gyógyszerészeti tudományok ,MESH: Biomedical Research ,Orvostudományok ,3. Good health ,Europe ,Transplantation ,Clinical trial ,Clinical research ,Multinational corporation ,[SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,MESH: Europe ,InformationSystems_MISCELLANEOUS ,business ,lcsh:Medicine (General) - Abstract
Background Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states. Methods In order to summarise the current situation in relation to the wide spectrum of clinical research, the European Clinical Research Infrastructures Network (ECRIN) developed a multinational survey in ten European countries. However a lack of common classification framework for major categories of clinical research was identified, and therefore reaching an agreement on a common classification was the initial step in the development of the survey. Results The ECRIN transnational working group on regulation, composed of experts in the field of clinical research from ten European countries, defined seven major categories of clinical research that seem relevant from both the regulatory and the scientific points of view, and correspond to congruent definitions in all countries: clinical trials on medicinal products; clinical trials on medical devices; other therapeutic trials (including surgery trials, transplantation trials, transfusion trials, trials with cell therapy, etc.); diagnostic studies; clinical research on nutrition; other interventional clinical research (including trials in complementary and alternative medicine, trials with collection of blood or tissue samples, physiology studies, etc.); and epidemiology studies. Our classification was essential to develop a survey focused on protocol submission to ethics committees and competent authorities, procedures for amendments, requirements for sponsor and insurance, and adverse event reporting following five main phases: drafting, consensus, data collection, validation, and finalising. Conclusion The list of clinical research categories as used for the survey could serve as a contribution to the, much needed, task of harmonisation and simplification of the regulatory requirements for clinical research in Europe.
- Published
- 2009
- Full Text
- View/download PDF