To the Editor: The statement from the International Committeeof Medical Journal Editors (ICMJE) with respect to the registrationof clinical trials (Sept. 16 issue)1 advocates the use of www.clinicaltrials.govas a registry. I am astonished by this recommendation becausethat registry does not fulfill the criteria demanded by theICMJE. Currently, only the U.S. federal agencies conductingor sponsoring clinical research and holders of an investigational-new-drugapplication under U.S. Food and Drug Administration regulationsmay apply for registration. In contrast, www.controlled-trials.com,an international registry, is open to every investigator. Thatthe editors do not mention this registry amazes me even morebecause several of them are European. The European guidelineson application for approval by competent authorities and ethicscommittees before commencement of a clinical trial of medicinalproducts include detailed instructions for application formsthat are used in the member states of the European Union. Theseapplication forms ask for the International Standard RandomisedControlled Trial Number (ISRCTN), which to my knowledge is givenonly in the registry at www.controlled-trials.com. The editorsshould clarify these contradictions.
Guido Grass, M.D. University of Cologne 50937 Cologne, Germany
Editor's note: Since this letter was written clinicaltrials.govhas been opened to any investigator in the world.
References
DeAngelis C, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med 2004;351:1250-1251. [Free Full Text]
To the Editor: The ICMJE supports a solution to the selectivereporting of clinical studies. Although efforts have been madeto encourage investigators to register their trials, registrationis still voluntary. Several major barriers to the developmentof a comprehensive registry of clinical trials have been described.1Research involving human subjects poses complex ethical issues.As stated by the ICMJE, patients who volunteer to participatein clinical trials deserve to know that their contribution tothe improvement of human health will be available to informhealth care decisions. Therefore, prospective trial registrationis an ethical obligation and should be a legally required componentof written informed consent.
Andres Felipe Cardona, M.D. Instituto Nacional de Cancerología Bogota 571, Colombia
Edgar Guillermo Ospina, M.D. Clinica Reina Sofía Bogota 571, Colombia
References
Dickersin K, Rennie D. Registering clinical trials. JAMA 2003;290:516-523. [Free Full Text]
To the Editor: The trial-registration initiative of the ICMJEis laudable. However, research sponsors are not the only stakeholderswho may lose a competitive edge through registration. Researchersfrom developing countries are at a disadvantage too. The timelycompletion and publication of research with limited resourcesand limited infrastructure already constitute a tall order.1,2A registration process that includes immediate disclosure ofresearch information could further retard the limited competitivenessof the developing world. What might be done is to have trialsregistered at the outset, but without the information beingpublicly accessible for a certain grace period. This approachwould ensure transparency but would not compromise any competitiveedge to which researchers who painstakingly design an innovativestudy are entitled.
Pisake Lumbiganon, M.D. Khon Kaen University Khon Kaen 40002,Thailand
References
Keiser J, Utzinger J, Tanner M, Singer BH. Representation of authors and editors from countries with different human development indexes in the leading literature on tropical medicine: survey of current evidence. BMJ 2004;328:1229-1232. [Free Full Text]
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