The Paediatric Regulation (2007) An increase in the number of paediatric clinical trials How can patients get the clinical outcomes that really matter to them?
How can the patients needs be integrated into clinical trials?
How can patients be better mobilised and empowered? EC Cooperation Work Programme HEALTH-2007-4.1-4: Identifying patients' needs in the clinical trials context. RESPECT Relating Expectations and needs to the Participation and Empowerment of Children in clinical Trials. Children & parents participating in clinical trials
Pharma industry Our sources of information The SACK model How do we encourage empowerment? Flexible recruiting, self-referral website, patient registers
The parents and children themselves identify the benefits and barriers to participation
Compatible with an overall health plan for that child (Sack) Self-determination Mechanisms for mutual exchange which encourage valued input, access to results
Train clinical staff about respect for and partnership with patients and patient organisations
Good Clinical Practice contract (saCk) Co-operation (sacK) Knowledge Education for the public about clinical trials (why and how)
Opportunities for patient groups to provide training for members and clinical staff
Decision tools (weigh risks versus benefits) Patient representation
Transparency of Clinical Trial procedures
Independent feedback on participation
Evaluation of the trials results and impact on the child (sAck) Accountability The SACK model can be used by all stakeholders to work together! Investigators & CT staff
Establish needs identified by children themselves in CTs.
Treat informed consent as a process not a one-off event.
Train staff in person-centred care.
Provide the study results in a child-friendly format. Policy makers
Require the inclusion of needs identified by children in CT prioritisation.
Establish an easily understandable level-of-risk scale for CTs.
Establish an EU advisory committee on informed consent material for children.
Extend GCP to include the patient perspective Patient organisations
Survey members for unmet treatment needs.
Lobby pharmaceutical companies to get the CTs that are relevant to members.
Give input on the CT design and outcomes that matter.
Identify members’ support needs surrounding CTs.
Monitor the child’s perspective during and after the CT. Ethics committees
Provide training to members about the EU paediatric regulation.
Network with other ethics committees for harmonisation.
Include patient organisation representatives on committees.
Make ethics committee methods and judgements transparent. Sponsors
Involve families and patient organisations in protocol design and prioritisation.
Provide education materials about CTs.
Develop patient-reported outcome measures.
Make details of planned, ongoing and completed CTs openly accessible on website.
Make the CT system more accountable to participants. Individually empowered participants take an active role in the CT process Conclusions Patient organisations can represent the patients views at all levels of the CT process. Cooperation will lead to the enrichment of the parent’s, the patient organisation’s and the CT team’s understanding of the medical condition. Together they are co-producers of improved health care More
Trials More children
trials To improve the health of children in Europe all new medicines must be clinical tested in paediatric populations. Recommendations 50% of medicines taken by children have never been tested in paediatric populations.
70% of medicines taken by new born children have never been tested in a controlled clinical trial. European Confederation of Specialist in Paediatrics 2005 Read more about the
in our new publication available
from our website. Child and parents Seek out the trials that meet your needs
Get informed about the clinical trials
Be sure you know what is involved.
Keep asking questions.
Negotiate what information you can expect before and after the Trial.
Ask for the results.
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