Clinical Trials

Clinical Trials Unit

Team members:

Dr David Ziegler, Head, Clinical Trials Unit

Helen Mueller, Clinical Research Manager

Dr Draga Barbaric, COG Principal Investigator

Dr Toby Trahair, SIOPEN Principal Investigator

Catherine Ferguson, Clinical Trials Specialist Nurse

Geraldine Bicol, Clinical Research Associate

Deirdre Kearney, Clinical Research Associate

Eshwini Tadiyal, Clinical Research Associate

Grace Wong, Clinical Research Associate

Fabyolla El-Tahche, Clinical Research Associate

Sally Anne Byatt, Clinical Research Associate

Annie Zheng, Clinical Trials Assistant

Aims/purpose of team:

The KCC Clinical Research Unit is focused on being at the forefront of paediatric oncology clinical research through participation in a broad range of Phase I, Phase II and Phase III Clinical Trials. The Clinical Trials Team collaborates with several national and international collaborative trial groups and pharmaceutical companies in order to facilitate this access to such a broad range of clinical trials for children with cancer. We also focus on the development of “home-grown” investigator initiated trials that focus on the translation of preclinical research to the bedside to directly benefit children with cancer.

The Clinical Trials Team supports the research efforts of the department by ensuring that all clinical trials are run in accordance with national and international ethical and regulatory standards including ICH-GCP and TGA guidelines.

Research:

The Clinical Trials Team collaborates on an international stage with many leading research collaborative groups in order to facilitate the implementation of all phases of clinical trials in the department. The team aims to build upon existing collaborations and to seek out potential new partnerships to further strengthen our clinical trials program.

Dr Draga Barbaric is the Australian Study Chair for ‘Study 9’ a Phase III international multicentre randomised clinical trial for children with newly diagnosed Acute Lymphoblastic Leukaemia (ALL) developed by the BFM-AIEOP group. Over the last 30 years, the BFM-AIEOP series of studies have led to incremental improvements in survival, so that today 80% of children with ALL are cured. Study 9 aims to build upon this success. ALL is the most common paediatric malignancy constituting about 25% of all childhood cancers. In Australia, about 150 children are diagnosed with ALL annually and just over half of these will be enrolled on Study 9. The KCC Clinical Trials Team has assumed the role of the National Coordinating Centre for Study 9 and will oversee the conduct of the trial for all Australian sites. 

A second area of focus for the team is Phase I/II studies. Up to 25% of children with cancer have a disease that is refractory to treatment or recurrent and the majority of these children will not survive. Phase I/II clinical trials represent a real treatment option for these patients and are central to the translation of basic science discoveries into new clinical treatments. **Link to Early phase clinical trials**

The Clinical Trials Unit at any time has 30-40 clinical trials open for patient enrolment.

The KCC actively collaborates with the following national and international collaborative trials groups on a large number of clinical trials:

  • Australia and New Zealand Children’s Haematology Oncology Groups (ANZCHOG)
  • Therapeutic Advances in Leukemia (TACL)
  • Children’s Oncology Group (COG)
  • International Society of Paediatric Oncology (SIOP)
  • New Approaches to Neuroblastoma Therapy (NANT)
  • German and Italian International Leukaemia group; AIEOP-BFM (Associazione Italiana Ematologia Oncologia Pediatrica - Berlin-Franklin-Munster).