More on compulsory registration of clinical trials
http://www.100md.com
《英国医生杂志》
EDITOR—The issue of trial registration has been considered for years but has only recently become a major issue, as underlined also by the International Committee of Medical Journal Editors (ICMJE) initiative.1
Although a single, all inclusive, worldwide register would be optimal, areas such as paediatrics need special attention since difficulties in carrying out paediatric studies have led to a lack of drug safety and efficacy knowledge in children.2 To facilitate collaborative research and identify areas where paediatric research is needed, the DEC-net international register (www.dec-net.org), supported by the European Union under its Fifth Framework Programme as a three year feasibility study,3 was activated in 2004. DEC-net complies with the criteria listed in the meta-Register of Controlled Trials (http://controlled-trials.com/mrct) to allow for future collaboration.
DEC-net fits ICMJE's criteria, is free of charge, and is designed for use by the general public and health professionals. It is different from EMEA's recent EudraCT database (http://eudract.emea.eu.int), which is accessible only to the competent authorities. This major limit will unfortunately, keep it from being directly useful to most researchers and the public.
The US ClinicalTrials.gov is mentioned by the ICMJE group as the only existing register that meets a set list of requirements. DEC-net is different from ClinicalTrials.gov in that it is the only paediatric, population oriented trial register and has been set up to receive trial information from different sources among the scientific and lay community. Abbasi's editorial expressed concern about ClinicalTrials.gov.4 The BMJ supports the ICMJE policy except for the endorsement of ClinicalTrials.gov, since it offers registration only to specific categories of sponsors. We agree with the editorial. To be at the forefront of such an initiative, a register should have worldwide aims and be designed with the idea, and capacity, to include all possible trials from different countries.5
M Bonati, head
mother_child@marionegri.it, Laboratory for Mother and Child Health, Mario Negri Pharmacological Research Institute, Via Eritrea 62, 20157 Milan, Italy
C Pandolfini, senior researcher
Laboratory for Mother and Child Health, Mario Negri Pharmacological Research Institute, Via Eritrea 62, 20157 Milan, Italy
DEC-net collaborative group
The DEC-net collaborative group are M Bonati, C Pandolfini, V Rossi, E Santoro, J M Arnau de Bolós, I Danés Carreras, I Fuentes Camps, J M Castel Llobet, E Jacqz-Aigrain, S Zarrabian, I Choonara, H Sammons, J Steingo.
Competing interests: None declared.
References
De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med 2004;351: 1250-1.
Choonara I. Clinical trials of medicines in children. BMJ 2000;321: 1093-4.
Bonati M, Pandolfini C, Rossi V, et al. Launch of a European paediatric clinical trials register. Paed Perinatal Drug Ther 2004;6: 38-9.
Abbasi K. Compulsory registration of clinical trials. BMJ 2004;329: 637-8.
Correspondence. Compulsory registration of clinical trials. BMJ 2004;329: 1043-4. (30 October.)
Although a single, all inclusive, worldwide register would be optimal, areas such as paediatrics need special attention since difficulties in carrying out paediatric studies have led to a lack of drug safety and efficacy knowledge in children.2 To facilitate collaborative research and identify areas where paediatric research is needed, the DEC-net international register (www.dec-net.org), supported by the European Union under its Fifth Framework Programme as a three year feasibility study,3 was activated in 2004. DEC-net complies with the criteria listed in the meta-Register of Controlled Trials (http://controlled-trials.com/mrct) to allow for future collaboration.
DEC-net fits ICMJE's criteria, is free of charge, and is designed for use by the general public and health professionals. It is different from EMEA's recent EudraCT database (http://eudract.emea.eu.int), which is accessible only to the competent authorities. This major limit will unfortunately, keep it from being directly useful to most researchers and the public.
The US ClinicalTrials.gov is mentioned by the ICMJE group as the only existing register that meets a set list of requirements. DEC-net is different from ClinicalTrials.gov in that it is the only paediatric, population oriented trial register and has been set up to receive trial information from different sources among the scientific and lay community. Abbasi's editorial expressed concern about ClinicalTrials.gov.4 The BMJ supports the ICMJE policy except for the endorsement of ClinicalTrials.gov, since it offers registration only to specific categories of sponsors. We agree with the editorial. To be at the forefront of such an initiative, a register should have worldwide aims and be designed with the idea, and capacity, to include all possible trials from different countries.5
M Bonati, head
mother_child@marionegri.it, Laboratory for Mother and Child Health, Mario Negri Pharmacological Research Institute, Via Eritrea 62, 20157 Milan, Italy
C Pandolfini, senior researcher
Laboratory for Mother and Child Health, Mario Negri Pharmacological Research Institute, Via Eritrea 62, 20157 Milan, Italy
DEC-net collaborative group
The DEC-net collaborative group are M Bonati, C Pandolfini, V Rossi, E Santoro, J M Arnau de Bolós, I Danés Carreras, I Fuentes Camps, J M Castel Llobet, E Jacqz-Aigrain, S Zarrabian, I Choonara, H Sammons, J Steingo.
Competing interests: None declared.
References
De Angelis C, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med 2004;351: 1250-1.
Choonara I. Clinical trials of medicines in children. BMJ 2000;321: 1093-4.
Bonati M, Pandolfini C, Rossi V, et al. Launch of a European paediatric clinical trials register. Paed Perinatal Drug Ther 2004;6: 38-9.
Abbasi K. Compulsory registration of clinical trials. BMJ 2004;329: 637-8.
Correspondence. Compulsory registration of clinical trials. BMJ 2004;329: 1043-4. (30 October.)