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.
A full description and discussion of these recommendations can be found in chapter 9 of the RESPECT book.
|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|
|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|
|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: