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Children's views on taking medicines and participating in clinical trials.
Nordenmalm, Sofia; Kimland, Elin; Ligas, Franca; Lehmann, Birka; Claverol, Joana; Nafria, Begonya; Tötterman, Ann Marie; Pelle, Benjamin.
Afiliación
  • Nordenmalm S; Departmentof Laboratory Medicine, Division of Clinical Pharmacology, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.
  • Kimland E; The Swedish Medical Products Agency (Läkemedelsverket), Uppsala, Sweden.
  • Ligas F; European Medicines Agency (EMA), Amsterdam, The Netherlands.
  • Lehmann B; The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), Bonn, Germany.
  • Claverol J; Institut de Recerca Sant Joan de Déu, Sant Joan de Déu Research Foundation, Barcelona, Spain.
  • Nafria B; Institut de Recerca Sant Joan de Déu, Sant Joan de Déu Research Foundation, Barcelona, Spain.
  • Tötterman AM; The Finnish Medicines Agency (FIMEA), Helsinki, Finland.
  • Pelle B; European Medicines Agency (EMA), Amsterdam, The Netherlands.
Arch Dis Child ; 104(9): 900-905, 2019 09.
Article en En | MEDLINE | ID: mdl-31201156
ABSTRACT

INTRODUCTION:

Limited information is available on the views of children taking medicines and participating in clinical trials. These views may contribute to a better understanding of what can be improved on in the development of medicines from their perspective.

OBJECTIVE:

To collect children's views on taking medicines and participating in clinical trials. MATERIALS AND

METHODS:

A question-based survey was conducted among children living in European Union countries between January and August 2015.

RESULTS:

Almost 900 children aged 10-17 years from Finland, Germany, Sweden, Spain and Hungary responded. Almost 40% had a chronic health condition. The most commonly used pharmaceutical forms were solid or liquid medicines for oral use and injectable medicines. Bad taste and pain during administration were reported as common problems. Of 785 respondents, 17% had been taking part in a clinical trial. Most respondents would potentially agree to take part in a clinical trial because the investigational medicine might improve their own health or that of other children. Concern that the investigational medicine might be harmful was the main reason to refuse participation, if asked to. Over half of the respondents were willing to learn more about clinical trials, preferably online.

CONCLUSIONS:

It is necessary to involve children in the development of age-appropriate pharmaceutical forms and in the design of clinical trials. Children and their carers should be provided with age-appropriate medical information in the most suitable channels. We have identified some common problems that children experience when taking medicines, and we conclude that children are interested in learning more and giving their opinions on clinical trials.
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Texto completo: 1 Base de datos: MEDLINE Asunto principal: Participación del Paciente / Drogas en Investigación / Enfermedad Crónica / Sujetos de Investigación / Consentimiento Informado de Menores Tipo de estudio: Qualitative_research Límite: Adolescent / Child / Female / Humans / Male País/Región como asunto: Europa Idioma: En Revista: Arch Dis Child Año: 2019 Tipo del documento: Article País de afiliación: Suecia

Texto completo: 1 Base de datos: MEDLINE Asunto principal: Participación del Paciente / Drogas en Investigación / Enfermedad Crónica / Sujetos de Investigación / Consentimiento Informado de Menores Tipo de estudio: Qualitative_research Límite: Adolescent / Child / Female / Humans / Male País/Región como asunto: Europa Idioma: En Revista: Arch Dis Child Año: 2019 Tipo del documento: Article País de afiliación: Suecia