The importance of clinical trials for the paediatric rheumatic diseases: Organisation, methodological and ethical problems

Research output: Contribution to journalArticlepeer-review

Abstract

The paediatric rheumatic diseases are rare condition associated with important sequelae on the quality of life of these children. The research aimed at studying new therapeutic approaches is difficult because of organisation, methodological and ethical problems. To face these problems in May 1996 it was founded an international research network called 'Paediatric Rheumatology International Trials Organisation - PRINTO' with the goal to promote, facilitate and conduct high quality research in the paediatric rheumatic diseases. PRINTO is composed of 4 main vertical structures: the Advisory Council, the international co-ordinating centre located in Pavia, Italy, one national co-ordinator in each country, and 140 centres (hospitals and/or Universities) in 32 countries worldwide. PRINTO is now conducting the following studies all financed by the European Community: 1. Methotrexate in medium versus higher doses in juvenile chronic arthritis (JCA): a total of 340 patients have been enrolled in the screening phase with 42 patients randomised to higher dose of MTX. 2. Quality of life project in the JCA with the cross-cultural adaptation and validation of the Childhood Health Assessment Questionnaire (CHAQ) and the Child Health Questionnaire (CHQ) with more than 4000 patients collected from 32 countries. 3. Core-set of outcome measures and definition of improvement for juvenile systemics lupus erythematosus and juvenile dermatomyositis. This international network represents a powerful tool to investigate future treatment in the paediatric rheumatic diseases.

Original languageEnglish
Pages (from-to)165-170
Number of pages6
JournalGaslini
Volume32
Issue number2
Publication statusPublished - 2000

Keywords

  • Controlled clinical trials
  • Paediatric rheumatic diseases
  • Quality of life

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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