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Arch Dis Child 94:717-719 doi:10.1136/adc.2008.148155
  • Drug therapy
  • Leading article

Registration of trials in children: update of current international initiatives

  1. Chiara Pandolfini1,
  2. Maurizio Bonati1,
  3. Helen M Sammons2
  1. 1
    Laboratory for Mother and Child Health, Department of Public Health, “Mario Negri” Pharmacological Research Institute, Milan, Italy
  2. 2
    Academic Division of Child Health, University of Nottingham, Derbyshire Children’s Hospital, Derby, UK
  1. Correspondence to Chiara Pandolfini, Laboratory for Mother and Child Health, Department of Public Health, “Mario Negri” Pharmacological Research Institute, Via Giuseppe La Masa 19, 20156 Milan, Italy; pandolfini{at}marionegri.it
  • Accepted 5 May 2009
  • Published Online First 19 May 2009

The last few years have been characterised by an increasing awareness of the inadequacy of children’s therapeutic options and of science’s insufficient knowledge in this area.1 2 The well-documented, frequent use of off-label and unlicensed medications in the young,3 4 with the increased risks it carries,5 can be seen as an indicator of the still limited knowledge on paediatric drug therapies. This lack of data is generally due to the greater difficulties inherent (ethical, practical and economic) in carrying out clinical trials in children. In such a context, given the scant evidence available on the safety and efficacy of drug therapies, the use of drugs in children is often inappropriate and not rational.6

Reasons for registers

With the awareness of the inadequate situation came the need to study paediatric research more closely to identify which disease areas are being addressed and which therapeutic needs of children are being ignored. The systematic analysis of drug use (also in children)7 and the analysis of off-label and unlicensed drug use data can be useful to highlight areas in which therapeutic knowledge is lacking. However, in order to direct research towards areas that are not being covered, as opposed to areas that are well-defined or over-exposed to research, knowledge of ongoing and planned research is also necessary; thus the importance of trial registers. Registers are the means by which researchers and anyone working in the healthcare field can access data on research being carried out and use such data to orient their therapeutic choices, their work and their research plans. In order for registers to be useful, however, data on all trials must be reported, even if fear of competition may hinder participation.8 Trial registration is, in fact, fundamental, and it is so for numerous reasons related to aspects of research …