Alternative E: Nordic Pediatric Research

Nordic Pediatric Research Network

Venue: Frøya 2

Theme: How can CTU contribute to investigator-initiated research in pediatric departments in Nordic University Hospitals

The purpose of this workshop is to discuss clinical trial units (CTU) that are specifically dedicated to work with children, with particular focus on how such units can contribute to investigator-initiated research in pediatric departments in Nordic university hospitals.

The subject was chosen on the background of study monitors reporting ‘potential for improvements’ in relation to the management of investigator initiated RCTs embedded in pediatric oncology treatment protocols. The focus will be on fruitful discussions and exchanges of opinions, aiming to construct better systems.

Margrete Einen from Medicines for Children Research Network, Norway (NorPedMed) will introduce NorPedMed and chair the session. The following speakers will initiate the debate:

  • Marit Hellebostad, MD, PhD

Pediatric oncologist, Drammen Hospital, Vestre Viken HF, and Nordic Society of Paediatric Haematology and Oncology (NOPHO)

Systematically combining research and treatment in common protocols; the success story and the current challenges of NOPHO.

  • Camilla Tøndel, MD, PhD

Pediatrician and responsible for the Clinical Trial Unit for Children, Haukeland University Hospital.

What is a pediatric CTU and what is NorPedMed? How can these structures provide support and facilitate clinical research in a busy environment at a pediatric department?

  • Martha Colban, Cand. Scient, biology/physiology 

Department for Clinical Research Support at Oslo University Hospital

The challenges facing hospitals responsible for the running of RCTs that are embedded in routine treatment protocols; experiences from the “monitoring side”.

  • Ingvild Aaløkken, Cand. Odont / DDS 

Head of Unit, section for preclinical assessment and clinical trials, Norwegian Medicines Agency (Statens Legemiddelverk), the approval and supervisory authority for clinical trials in Norway.

Are there ‘signs or evidence’ that hospitals responsible for the running of RCTs that are embedded in routine treatment protocols need professional GCP support?

  • Britt Nakstad, MD, PhD

Pediatrician, professor and responsible for research at Akershus University Hospital (Ahus)

Why should Ahus, a medium sized Norwegian university hospital, establish a pediatric CTU and join NorPedMed?

 

Lunch is served 11:30 – 12:30

 

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