Common definition for categories of clinical research: A prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)

Publikation: Beitrag in FachzeitschriftForschungsartikelBeigetragenBegutachtung

Beitragende

  • Christine Kubiak - , INSERM - Institut national de la santé et de la recherche médicale (Autor:in)
  • Fernando De Andres-Trelles - , Complutense University (Autor:in)
  • Wolfgang Kuchinke - , Heinrich Heine Universität Düsseldorf (Autor:in)
  • Karl Heinz Huemer - , Medizinische Universität Wien (Autor:in)
  • Steffen Thirstrup - , Universität Kopenhagen (Autor:in)
  • Kate Whitfield - , Universität Kopenhagen (Autor:in)
  • Christian Libersa - , INSERM - Institut national de la santé et de la recherche médicale (Autor:in)
  • Béatrice Barraud - , INSERM - Institut national de la santé et de la recherche médicale (Autor:in)
  • Xina Grählert - , Koordinierungszentrum für Klinische Studien Dresden (KKS-DD) (Autor:in)
  • Gabriele Dreier - , Albert-Ludwigs-Universität Freiburg (Autor:in)
  • Ruth Grychtol - , Albert-Ludwigs-Universität Freiburg (Autor:in)
  • Zsuzsa Temesvari - , Ministry of Human Resources of Hungary (Autor:in)
  • Gyorgy Blasko - , Ministry of Human Resources of Hungary (Autor:in)
  • Gabriella Kardos - , Ministry of Human Resources of Hungary (Autor:in)
  • Timothy O'Brien - , University of Galway (Autor:in)
  • Margaret Cooney - , Molecular Medicine Ireland (ICRIN) (Autor:in)
  • Siobhan Gaynor - , Molecular Medicine Ireland (ICRIN) (Autor:in)
  • Arrigo Schieppati - , IRCCS Istituto di ricerche farmacologiche Mario Negri - Milano, Bergamo, Ranica (Autor:in)
  • Nuria Sanz - , University of Barcelona (Autor:in)
  • Raquel Hernandez - , University of Barcelona (Autor:in)
  • Charlotte Asker-Hagelberg - , Karolinska Institutet (Autor:in)
  • Hanna Johansson - , Karolinska Institutet (Autor:in)
  • Sue Bourne - , UK Clinical Research Collaboration (Autor:in)
  • Jane Byrne - , Manchester University NHS Foundation Trust (Autor:in)
  • Adeeba Asghar - , NIHR Clinical Research Network (CRN) (Autor:in)
  • Jean Marc Husson - , European Forum for Good Clinical Practice (Autor:in)
  • Christian Gluud - , Universität Kopenhagen (Autor:in)
  • Jacques Demotes-Mainard - , INSERM - Institut national de la santé et de la recherche médicale (Autor:in)

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.

Details

OriginalspracheEnglisch
Aufsatznummer95
FachzeitschriftTrials
Jahrgang10
PublikationsstatusVeröffentlicht - 16 Okt. 2009
Peer-Review-StatusJa

Externe IDs

PubMed 19835581

Schlagworte