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Registering clinical trials

BMJ 2000; 320 doi: (Published 13 May 2000) Cite this as: BMJ 2000;320:1339

Register of clinical trials in children must be set up

  1. Maurizio Bonati, head (,
  2. Piero Impicciatore, senior research fellow,
  3. Chiara Pandolfini, research fellow
  1. Laboratory for Mother and Child Health, Istituto di Ricerche “Mario Negri,” 20157 Milan, Italy
  2. Pharmacy Department, Policlinico GB Rossi, 10-37134 Verona, Italy
  3. Pharmacy Department, Azienda Ospedaliera San Camillo-Forlanini, 00100 Rome, Italy
  4. Italian Society of Hospital Pharmacy, 18-20129 Milan, Italy

    EDITOR—Tonks's paper 1 and other efforts to boost registration of new clinical trials 2 should be supported. Registration of clinical trials would benefit evidence based health care and freedom of information and, more importantly, would benefit patients, particularly children.

    Randomised controlled trials aimed at meeting the requirements of regulatory agencies are seldom carried out in paediatric patients, and many children thus receive drugs that do not have labelling for paediatric use.3 Furthermore, there is an imbalance in the distribution of efforts and resources. Systematic studies (and reviews) have focused mainly on a few childhood illnesses such as asthma, otitis media, and respiratory tract infections—as found by consulting the Cochrane Library.

    This longstanding, underprivileged position of children underlines the need for further approaches aimed at promoting the rational use of drugs in paediatric patients. Over the past 20 years the number and diversity of databases available to the biomedical research community …

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