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Children’s views on taking medicines and participating in clinical trials
  1. Sofia Nordenmalm1,
  2. Elin Kimland2,
  3. Franca Ligas3,
  4. Birka Lehmann4,
  5. Joana Claverol5,
  6. Begonya Nafria5,
  7. Ann Marie Tötterman6,
  8. Benjamin Pelle3
  1. 1 Departmentof Laboratory Medicine, Division of Clinical Pharmacology, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden
  2. 2 The Swedish Medical Products Agency (Läkemedelsverket), Uppsala, Sweden
  3. 3 European Medicines Agency (EMA), Amsterdam, The Netherlands
  4. 4 The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), Bonn, Germany
  5. 5 Institut de Recerca Sant Joan de Déu, Sant Joan de Déu Research Foundation, Barcelona, Spain
  6. 6 The Finnish Medicines Agency (FIMEA), Helsinki, Finland
  1. Correspondence to Mrs. Sofia Nordenmalm, Karolinska University Hospital Solna, Clinical Pharmacology L7:03, 171 76 Stockholm,Sweden ; sofia.nordenmalm{at}hotmail.com

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.

  • paediatric practice
  • patient perspective
  • qualitative research
  • therapeutics
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Footnotes

  • Contributors SN and BP were responsible for the distribution and collection of the survey. SN and EK were responsible for data analysis and interpretation, and all other authors critically reviewed the results. All authors contributed to writing the article (drafting of the article by SN and EK, and critical review and revision by all others). All authors gave their final approval of the version to be published.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Disclaimer The views expressed in this article are the personal views of the author(s) and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties, national competent authorities, hospitals or research centres.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Patient consent for publication Not required.

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