ELTR-News

News from the European Leukemia Trial Registry (ELTR)

Author: A. Hellenbrecht, Universitätsklinikum Frankfurt, GermanyInformation Letter No.5, August 2008

It is well known, that the International Committee of Medical Journal Editors (ICMJE) accepts only WHO-registered trials for potential publication. According to the statements of the ICMJE and WHO from 2004 and 2005 1,2,3, all ongoing studies are accepted, that are registered before September 13, 2005. All studies – initiated after this date - must be registered before the enrollment of the first patient.
In the beginning in 2004, the study-registration was limited to so called “interventional studies”. Now, the ICMJE will begin to implement the WHO definition of clinical trials for all trials that begin enrolment on or after July 1, 2008. This definition states that a clinical trial is “any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.”
The WHO/ICMJE rules for registration and the definitions of what a proper trial registry is, changed arbitrarily in the last years. The latest information from WHO/ICMJE confirmed, that only one trial registry per country (National Registry) would be accepted. You will find a list of actually WHO-accepted registries at: http://www.who.int/ictrp/network/ list_registers/en/index.html The majority of the European countries have no national registries at the moment. So it´s currently recommended to register all trials with one of the WHO-listed primary registries. Most probably the NIH registry http://www.clinicaltrials.gov is also accepted although it is deleted from the list of primary registries at the moment.

Beyond the mentioned duties, the European Leukemia Trial Registry (ELTR) has the genuine aim to inform physicians and patients in Europe about ongoing trials. We would like to encourage all physicians and researchers to register their trials furthermore also in the ELTR.
The short protocol template which is found HERE can be sent to the Information Center. This is sufficient to register the trial in the ELTR. Even more easily you may provide us your registration number in one of the other registries.
For further information please contact the European Leukemia Information Center: elic@em.uni-frankfurt.de

References

  1. De Angelis Cc, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, van der Weyden MB, International Committee of Medical Journal Editors: Clinical trial registration: a statement from the International Committee of Medical Journal Editors. Lancet 2004 Sep 11-17;364(9438):911-2 (2004) [pmid:15364170]
  2. De Angelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, Kotzin S, Laine C, Marusic A, Overbeke AJ, Schroeder TV, Sox HC, van der Weyden MB, International committee of medical journal editors: Is this clinical trial fully registered? A statement from the International Committee of Medical Journal Editors. Lancet 2005 May 28-Jun 3;365(9474):1827-9 (2005) [pmid:15924965]
  3. Laine Cc, de Angelis C, Delamothe T, Drazen JM, Frizelle FA, Haug C, Hébert PC, Horton R, Kotzin S, Marusic A, Sahni P, Schroeder TV, Sox HC, van der Weyden MB, Verheugt FW: Clinical trial registration: looking back and moving ahead Ann Intern Med 2007 Aug 21;147(4):275-7 (2007) [pmid:17548404]