RESPECT: Relating Expectations and Needs to the Participation and Empowerment of Children in Clinical Trials

Project overview

Studies have shown that over 50% of the medicinal products used in children may not have been tested or authorised for use in this age group. This leaves health care professionals with no alternative but to use medicines "off-label", judging the suitability and the correct dose of these medicines themselves in the absence of paediatric labeling information. This poses significant risks of inefficacy and/or adverse reactions for children.

The EU regulation (EC No. 1901/2006 on Medicinal Products for Paediatric Use) came into effect in January 2007 to ensure that medicinal products that are researched, developed and authorised in Europe will also meet the therapeutic needs of children. This will mean an increased demand for children to participate in clinical trials of new medicines.

The European research project RESPECT, led by the Institute of Clinical Sciences at the Sahlgrenska Academy at Gothenburg University, Sweden, set out to identify the needs and motivations of children and their families who have participated or might participate in clinical trials in Europe.

We explored the issues raised by children's participation in medical research by speaking with paediatric patients and their parents, patient support organisations, paediatricians, ethical committees and representatives of the pharmaceutical industry to gather their experience, insights and suggestions. This enabled us to make recommendations for how to empower children such that medical researchers respect their interests and can motivate their participation in future clinical trials.

Please see the Publications below for our presentations and articles.

RESPECT: Main recommendations to stakeholders

A full description and discussion of these recommendations can be found in chapter 9 of the RESPECT book.
Recommendations to stakeholders

RESPECT project dissemination meeting presentations (Brussels, 25 May 2011)

Authors Title
John Chaplin Overview of the RESPECT project and the paediatric clinical trials landscape
Adriana Ceci View from the Paediatric Committee of the EMA
Catriona Chaplin Young patients’ and their parents’ experiences of clinical trials
Pia-Sophie Wool Recruiting children to paediatric clinical trials – the view from the clinician
Annagrazia Altavilla Involving children in decision-making – what are their rights?
Falk Wulf How do families make the decision to participate?
Monika Bullinger Patient-reported outcomes - what matters to the child?
Cristina Manfredi Clinical trial networks – how can the patient or parent play an active part?
Liuska Sanna What do patient organisations want their role to be?
Francis P. Crawley Promoting transparency in European paediatric clinical research
(all) Breakout workshop reports

Conference presentations

Authors Title Conference Date
John Chaplin & the RESPECT project How to improve recruitment and retention in paediatric clinical trials Swedish Society of Medicine (SVLS) Annual conference, Stockholm 30 Nov - 1 Dec 2011
Annagrazia Altavilla Research with children: current trends and perspectives International Symposium: Convention on Human Rights and Biomedicine - updated or outdated?, Coimbra, Portugal 12 July 2011
Chaplin, Neubauer, Wulf, v. Mackensen, Sanna & Chaplin Mutual Respect and Shared Goals for Clinical Trials on Children 1st Global Congress for Consensus in Pediatrics & Child Health (CIP), Paris 17-20 Feb 2011
Wulf, Chaplin, Sanna, Neubauer, Crawley, Giaquinto, Ceci, Bullinger & Chaplin RESPECT: Good practice in empowering families in clinical trials PatientPartner final workshop: Patients Partnering in Clinical Trials, Brussels 7-8 Dec 2010
Chaplin, Chaplin, Pfeiffer-Mosesson & the RESPECT project Securing children’s participation in clinical trials Swedish Society of Medicine (SVLS) Annual conference, Gothenburg 1-3 Dec 2010
Sandberg, Chaplin & Chaplin Beyond Informed Consent: Educating parents to empower them in the clinical trial process Swedish Society of Medicine (SVLS) Annual conference, Gothenburg 1-3 Dec 2010
Chaplin, Pfeiffer-Mosesson & Chaplin RESPECT project: Why do parents let their children participate in clinical trials? Swedish pharmacists annual conference: Läkemedelskongressen, Stockholm 20-21 Oct 2009


Authors Title Journal Date
Wulf F, Krasuska M & Bullinger M for the RESPECT Study Group Determinants of Decision-making and Patient Participation in Paediatric Clinical Trials: A literature review Open Journal of Pediatrics Feb 2012
A Altavilla, C Manfredi, P Baiardi, M Dehlinger-Kremer, P Galletti, A Alemany Pozuelo, J Chaplin, A Ceci Impact of the new European paediatric regulatory framework on ethics committees: overview and perspectives ACTA PAEDIATRICA July 2011
Andrea Sandberg Masters thesis: Beyond Informed Consent - Educating patients to empower them in the clinical trial process (Masters thesis, Uppsala University) June 2010
Altavilla A, Giaquinto C, Giocanti D, Manfredi C, Aboulker JP, Bartoloni F, et al. Activity of ethics committees in Europe on issues related to clinical trials in paediatrics: Results of a survey Pharmaceuticals Policy and Law 2009
Altavilla A, Giaquinto C, Ceci A European survey on ethical and legal framework of clinical trials in paediatrics: results and perspectives J Int Bioethique 2008

The RESPECT consortium consisted of experts from the fields of clinical research, patient representation, and European paediatric research ethics and regulation. The following experts were partners in the RESPECT project:

  • Francis Crawley ( ) - Good Clinical Practice Alliance (Europe)
  • Good Clinical Practice Alliance (Europe) is a consultancy group active in the area of ethics as related to CTs and medical research throughout Europe.
  • Liuska Sanna, European Patients Forum
  • The EPF is a European umbrella NGO representing 44 chronic disease-specific patient organisations. The EPF works at the European level and with national coalitions of patients' organisations. EPF was the leading coordinator of the Value+ project promoting patients involvement in EU supported health-realted projects.

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