The Medical Oncology Clinical Trials Units in Sydney West Area Health Service was established at Westmead Hospital in 1987 and now also has sites at Nepean and Blacktown Hospitals.  Over that time, the Unit has undertaken over 500 trials in thousands of patients using cytotoxic chemotherapy, antibody therapies, vaccines and more recently small molecule targetted therapies.

 

The majority of studies have been Phase 2 and 3, either sponsored by pharmaceutical companies, investigator initiated or from collaborative groups such as the ANZ Breast Cancer Trials Group, the Sydney Melanoma Unit, the Australian Gastrointestinal Cancer Trials Group, the ANZ Urological and Prostate Cancer Trials Group (incorporating the ANZ Germ Cell Trials Group) and others.

 

In Jul 2009, the unit commenced its Phase 1 Programme using a B-RAF inhibitor in malignant melanoma and further phase 1 studies are in the pipeline.

 

The unit has a close working relationship with the Millennium Institute and the Westmead Institute for Cancer Research (WICR), which allows for many translational research opportunities.

 

The Trial Unit adheres to rigourous quality assurance processes and follows International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines for undertaking clinical trials.

 

The Unit has had successful external audits by ECOG, NCI and pharma auditors (Sanofi Aventis).

 

Details regarding Investigators can be found here

 

You can contact the Trials Unit Manager here.

 

The IRB for Westmead hospital is the Human Research Ethics Committee (HREC).  There is also a Scientific Review Committee and a Drug Committee.  A submission to the HREC will incorporate the review from the other two committees automatically.

 

The submission and meeting dates for the HREC is attached below.

 

An overview of the HREC submission process is attached below.

 

The costs for submission and invoice template is attached below.

 

More information on the submission process can be found here.