Issues and recommendations for patient empowerment of children in clinical trials.

1. RESPECT
Relating Expectations and needs to
the Participation and Empowerment
of Children in clinical Trials.
Contact information:
John Chaplin, Gothenburg University (gu), Sweden (.se)
www.patientneeds.eu
http://issuu.com/respect_patient_needs/docs/respect_book
http://prezi.com/7e50lx-qoeup/respect-patient-needs/

2. RESPECT Project Partners
 Sweden - University of Gothenburg
 Germany - University Hospital of Hamburg-Eppendorf
 Europe - European Patients’ Forum
 Slovenia - University Children's Hospital Ljubljana
 Europe - Good Clinical Practice Alliance
 Italy - University Hospital of Padova
 Italy - Centre for Biological and Pharmacological
Evaluation (Pavia)

3. The Paediatric Regulation (2007)
• To improve the health of children in Europe by:
– facilitating the development and availability of
medicines for children aged 0 to 17 years,
– ensuring that medicines for use in children are of high
quality, ethically researched, and authorised
appropriately,
– improving the availability of information on the use of
medicines for children,
• without:
– subjecting children to unnecessary trials, or delaying
the authorisation of medicines for use in adults.

4. EC Cooperation Work Programme
HEALTH-2007-4.1-4: Identifying patients'
needs in the clinical trials context.
• 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?

5. Methods Results Recommendations
Opinion gathering from
patients, clinicians,
regulators, and
researchers
Web based
questionnaires Expectations
Literature Needs
Empowerment
mobilisation
Best
practice
Case studies Workshops

6. Our sources of information
• Children & parents participating in clinical trials
• Patient Organisations
• Ethics committees
• Academia
• Paediatricians
• CT staff
• Pharma industry

7. Recommendations
for how to increase
Patient
Empowerment

8. 1. through partnership
– Mechanisms for mutual exchange which
encourage valued input, access to results
– Train clinical staff about respect for and
partnership with patients and patient
organisations
– Patient representation and transparency
• CT procedures
• Ethics committees (GCP)
– GCP contract

9. 2. through organisation
– Patient organisations – active advocacy
groups
– Independent bodies for feedback about
participation
– Oversight through monitoring and evaluation
of the experience of involvement and
empowerment.
– Evaluation of the trials results and impact on
the child.

10. 3. through knowledge
– Decision tools (weigh risks versus benefits)
– Education for the public about clinical trials
(why and how)
– Opportunity to advocate for the patient
group
– Independent ombudsman

11. 4. through self-determination
– 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.

12. All stakeholders can work together!

13. Conclusion
• Individually empowered participants take an active role
in the CT process
• Patient organisations can represent the patients views at
all levels of the CT process.
• An outcome of closer cooperation will be an enrichment
of the parent’s, the patient organisation’s and the CT
team’s understanding of the medical condition and
together getting the outcomes that really matter to all.
• Together they are co-producers of improved health care