Correspondence

Clinical Trial Registration

N Engl J Med 2005; 352:198-199January 13, 2005

Article

To the Editor:

The statement from the International Committee of Medical Journal Editors (ICMJE) with respect to the registration of clinical trials (Sept. 16 issue)1 advocates the use of www.clinicaltrials.gov as a registry. I am astonished by this recommendation because that registry does not fulfill the criteria demanded by the ICMJE. Currently, only the U.S. federal agencies conducting or sponsoring clinical research and holders of an investigational-new-drug application under U.S. Food and Drug Administration regulations may apply for registration. In contrast, www.controlled-trials.com, an international registry, is open to every investigator. That the editors do not mention this registry amazes me even more because several of them are European. The European guidelines on application for approval by competent authorities and ethics committees before commencement of a clinical trial of medicinal products include detailed instructions for application forms that are used in the member states of the European Union. These application forms ask for the International Standard Randomised Controlled Trial Number (ISRCTN), which to my knowledge is given only in the registry at www.controlled-trials.com. The editors should clarify these contradictions.

Guido Grass, M.D.
University of Cologne, 50937 Cologne, Germany

1 References

1. 1

   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
   Full Text | Web of Science | Medline

To the Editor:

The ICMJE supports a solution to the selective reporting of clinical studies. Although efforts have been made to encourage investigators to register their trials, registration is still voluntary. Several major barriers to the development of a comprehensive registry of clinical trials have been described.1 Research involving human subjects poses complex ethical issues. As stated by the ICMJE, patients who volunteer to participate in clinical trials deserve to know that their contribution to the improvement of human health will be available to inform health care decisions. Therefore, prospective trial registration is an ethical obligation and should be a legally required component of written informed consent.

Ludovic Reveiz, M.D.
Clinica Reina Sofía, Bogota 571, Colombia
lureveiz@colsanitas.com

Andres Felipe Cardona, M.D.
Instituto Nacional de Cancerología, Bogota 571, Colombia

Edgar Guillermo Ospina, M.D.
Clinica Reina Sofía, Bogota 571, Colombia

1 References

1. 1

   Dickersin K, Rennie D. Registering clinical trials. JAMA 2003;290:516-523
   CrossRef | Web of Science | Medline

To the Editor:

The trial-registration initiative of the ICMJE is laudable. However, research sponsors are not the only stakeholders who may lose a competitive edge through registration. Researchers from developing countries are at a disadvantage too. The timely completion and publication of research with limited resources and limited infrastructure already constitute a tall order.1,2 A registration process that includes immediate disclosure of research information could further retard the limited competitiveness of the developing world. What might be done is to have trials registered at the outset, but without the information being publicly accessible for a certain grace period. This approach would ensure transparency but would not compromise any competitive edge to which researchers who painstakingly design an innovative study are entitled.

Kittisak Kulvichit, M.D.
Wanla Kulwichit, M.D.
Chulalongkorn University, Bangkok 10330, Thailand
kittisak.k@chula.ac.th

Pisake Lumbiganon, M.D.
Khon Kaen University, Khon Kaen 40002, Thailand

2 References

1. 1

   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
   CrossRef | Web of Science | Medline

2. 2

   Smith R. Publishing research from developing countries. Stat Med 2002;21:2869-2877
   CrossRef | Web of Science | Medline

Citing Articles (2)

Citing Articles

1. 1

   Evelyne Jacqz-Aigrain, Sétareh Zarrabian, Chiara Pandolfini, Maurizio Bonati, Helen Sammons, Imti Choonara, Imma Danés, Imma Fuentes, Joseph Arnau. (2006) Le registre européen des essais cliniques pédiatriques est une réalité. Thérapie 61:2, 121-124
   CrossRef

2. 2

   Zarin, Deborah A., . (2005) Clinical Trial Registration. New England Journal of Medicine 352:15, 1611-1611
   Full Text

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