experiences from a pediatric clinical research unit ... · medicines for children • not enough...
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Experiences from a pediatric clinical research unit
Pediatric Clinical Research Center at the Sahlgrenska University Hospital
Jenny Kindblom , MD, PhDMedical Director PCRC
Medicines for children
• Not enough knowledge on the effect and safety ofmedicines in the pediatric population (<18 years of age)
• Treatment off-label common
• Pediatric drug development plans FDA, EMA
Pediatric Regulation 10 years (2007-2016)
50% more pediatric trials
260 new medicines authorised
Challenges
‒ Children only disorders
‒ Clinical trials (recruitment)
This is Västra Götaland
1.7 million inhabitants
49 municipalities, 24 000 km2
Major city: Gothenburg
About health carein Sweden
Free and equal access to public health care
Health interventions are financed by taxes, state funding and custom fees
Counties or regions - responsible for the health care at hospitals and local health centres
Municipalities - responsible for elderly personal care
Queen Silvia Children’sHospital
One of the nodes within Clinical Studies Sweden-and part of the SwedPedMed national network
Health Care PCRC &
pediatricpatients
Academy
Industry
Pediatricclinical trials
Large need /demand
Academic studies Industry-sponsoredClinical knowledge gaps
Complexities
ScientificEthically / morally
Practical issues
Small populations
Few children with diagnoses
Heterogeneity
How can pediatric clinical research be facilitated ?
”What research support would you need for your(academic) research?”
”What research support would you need to be ableto participate /more often/ in industry-sponsored trials?”
How can pediatric clinical research be facilitated ?
Industry-sponsored trials:
• GCP
• Agreement, legal support
• Economy, budget
• Administration
• Monitoring
• Research nurses
In academic research:
• Statistics
• Economy/Budget
• Data management / useof registers
• Research nurses
Pediatric Clinical Research Center
A resource for everyone within the health care, academia or industry who wish to pursue pediatric clinical research in Västra Götaland.
Conduct of pediatric trials
• High quality trials - expertise in conductof pediatric trials• From feasibilty to closing the trial, from discussion scientific rationale to practical and administrative issues
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!!
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Feasibility support
Start-up supportFeasibility, budget –
agreement, legal agreements, allocation of
personnelEducationGCP, conduct of pediatric trials,
scientific experience and involvment for
physicians/nurses
Maintenance supportCoordination,
administration, documentation,
monitoring
Start-up supportFeasibility, budget –
agreement, legal agreements, allocation of
personnelEducationGCP, conduct of pediatric trials,
scientific experience and involvment for
physicians/nurses
Maintenance supportCoordination,
administration, documentation,
monitoring Medical advisorProject leader
Trial coordinatorLegal representative
Research nursesMonitors
Administrative support
Educators/project leadersMedical advisor
Our mission • To facilitate clinical research
• …both academic and industry-sponsored
• …in Pediatrics, but also in all other specialities treating children (Child and AdolescentPsychiatry, Infection, ENT, Surgery…)
• …by doing as little or as muchas needed
Identifiedneeds
Start-upGetting
organisedEveryone aboard?
Let´s go!
The Swedish example
• Local facilitation is crucial !
• PCRC at the SahlgrenskaUniversty Hosital is a resource for everyone within the health care, academia or industry who wish to pursue pediatric clinical research in VästraGötaland.
Vision: be an integrated part of life at the Queen Silvia Children´s
hospital
Thank you