Clinical Trials Unit

Facilitating advances in medical care!

The Clinical Trials Unit (CTU) based at the Gallipoli Medical Research Foundation consists of a team of specialist research nurses and scientists.

We provide our research partners with first-class conduct, management and coordination of multi-centre national and international clinical research trials.

Our aim is to deliver clinicians and patients with access to new and emerging medications in an effort to advance medical care for all.

Clinical Trials Day

About clinical trials

The GMRF Clinical Trials Unit is a cross discipline, collaborative facility established to organise, coordinate and conduct investigator initiated clinical trials and sponsored pharmaceutical company trials.

Benefits of our clinical trials

These phase I-IV clinical trials benefit the community through enhanced medical knowledge about the place and value of new treatments. Medical specialists can gain experience with new therapies and trial participants can take part in study protocols of new and potentially improved therapies. The result is enhanced quality of care and treatment not available as standard care.

Information for the medical community: Conducting a trial with the CTU

The CTU team manages all documentation of clinical trials including paper and computer based case record forms. We also assist with study design, regulatory affairs, database maintenance, and participant recruitment. The CTU takes responsibility for liaising between the Gallipoli Medical Research Institute, the Therapeutic Goods Administration (TGA) and local ethics committees.

Future plans for the unit include increasing our capacity to assist more clinical researchers with the management of clinical trials.  Our dedicated CTU facilities are based on the campus of Greenslopes Private Hospital and we can support any investigator accredited to consult at the hospital. In addition, our staff develop successful partnerships with pharmaceutical companies and research organisations - large and small.

We provide our research partners with first-class conduct, management and coordination of multi-centre national and international clinical research trials. Our aim is to deliver clinicians and patients with access to new and emerging medications in an effort to advance medical care for all.

If you would like to conduct a clinical trial under the auspices of the CTU, please contact Miriam Dwyer (CEO of the Gallipoli Medical Research Foundation).

Information for potential trial participants

All CTU trials are run under strict conditions. Our Clinical Trial Coordinators ensure that you are treated with the utmost care, while our Data Manager oversees the meticulous data entry for each of your participant visits. In addition, trial monitors from each company involved in our trials visit us regularly and double check every single number that we enter in order to ensure the trial is run correctly.

You will never be ‘out of pocket’ health wise for participating in a trial; every patient gets the standard of care treatment – alone or combined with a new treatment. Our job is to work with you to make sure that any new treatments truly live up to their claims. By doing that, we can together improve future health outcomes for all Australians and the wider global community.

Please visit the pages of our website which list the studies which are currently open for recruitment to see if there is a trial in which you are interested in taking part. You may also wish to complete this form if you would like to be notified of future clinical trials which might be of interest to you.

 

Our Team

Suzanne Elliott

Suzanne Elliott

Suzanne Elliott joined the Foundation in November 2016 as the Clinical Trial Unit Manager. Suzanne has been involved in clinical research for over 25 years, with a doctorate in molecular oncology and post-doctorate in infectious/viral/cancer immunology clinical trials. She has a special interest in early phase drug development, Phase I clinical trials, working with a Phase I company for over a decade.  She has qualifications in drug development and has extensive experience particularly in ethics and regulatory affairs and Good Clinical Practice. Suzanne’s focus is to provide a professional and supportive role to the Foundation’s clinical team in its aim to pursue clinical research excellence in emerging new therapies that may benefit our patients.

CTU - Vanessa Irvine

Vanessa Irvine

Vanessa Irvine has recently joined the Gallipoli Medical Research Foundation, employed as a Clinical Trial Administrator to help facilitate the Ramsay Health Care Clinical Trial Network rollout and assist the Clinical Trial Unit with contracts and budgets.  She was recruited from a global Clinical Research Organisation, and has had 15 years’ experience in the industry.

CTU - Nish Santrampurwala

Nishreen Santrampurwala

Nishreen Santrampurwala joined the Gallipoli Medical Research Foundation 5 years ago, initially working on Liver Disease research, and completing her PhD in this field.  She then began working for the Clinical Trial Unit in Sep 2016 as a Clinical Trial Assistant, responsible for supporting the Clinical Trial Coordinators, and is primarily laboratory based.

CTU - Dee Prasad

Deepal Prasad

Deepal Prasad joined the Gallipoli Medical Research Foundation as a Clinical Trial Assistant in August 2016, supporting the Clinical Trial Coordinators and managing the laboratory samples.  Deepal has a background in biomedical science, with particular interest in microbiology and the public health system, and has experience working on an array of early phase clinical trials.

 
CTU - Bronwyn Casey

Bronwyn Casey

Bronwyn Casey joined the Gallipoli Medical Research Foundation in September 2012 as a Clinical Trials Assistant, and has been employed as a Clinical Trial Coordinator since March 2014 and was promoted to Senior Clinical Trial Coordinator (Oncology) November 2016.  Bronwyn has a biomedical science background with majors in immunology and infectious disease and physiology. Bronwyn has extensive experience in all aspects of phase I – IV clinical trials and good clinical practice, with a particular interest in metastatic melanoma clinical trials.  Bronwyn’s focus is to support the roles of her colleagues and investigators, promoting excellence in research to optimise patient well-being and care.

CTU - Rachel Wong

Rachel Wong

Rachel Wong joined the Gallipoli Medical Research Foundation back in August 2014 and commenced working as a Clinical Trials Assistant. She has since then moved over to work as a Data Manager for several months and has now settled into her newly appointed role as a Clinical Trial Coordinator. Rachel has a background in biomedical science, with a major in human anatomy and physiology. Over the years, she has gained significant knowledge and experience across Phase I - IV Clinical Trials and strives to provide optimal care to all patients.

CTU - Jess Eedy

Jessica Eedy

Jessica Eedy joined the Gallipoli Medical Research Foundation in March 2010 as a Clinical Trial Coordinator and was promoted to Senior Clinical Trial Coordinator in 2014. Jessica has transitioned in 2016 into the newly appointed role of Ethics Coordinator and focuses on ethics and regulatory correspondence, and essential documentation management. Jessica has a scientific background in biotechnology and biochemistry. Jessica has over 10 years’ experience in clinical trials, particularly in phase I-III, working with a number of pharmaceutical and biotechnology companies. She has valuable experience and knowledge in patient care, protocol and consent form review and study start-up activities, in addition to quality assurance and good clinical practice. Jessica’s focus is to provide a professional and high standard approach to clinical research and representing the Foundation.

CTU - Amanda Mason

Amanda Mason

Amanda Mason joined the Gallipoli Medical Research Foundation in December 2007 as a Clinical Trial Coordinator. Amanda has been a nurse for over 30 years and has worked in several specialised nursing areas. She has worked on phase I-IV clinical trials since her employment and was promoted to Senior Clinical Trial Coordinator in 2012. With her extensive knowledge and experience in trial coordination and diligence with ensuring quality data is produced, Amanda has ventured into the newly appointed role of Data Manager in 2016 where she will also continue her role in the management of education and training of the CTU staff. Amanda’s focus is in supporting and educating the CTU staff and ensuring the unit produces data that is high quality and meets protocol and Good Clinical Practice standards.

 
CTU - Sharon Senini

Sharon Senini

Sharon joined the Foundation in April 2016 as a Clinical Trial Coordinator. Sharon had been involved in clinical trial research for more than 10 years’ and has a scientific background in microbiology. She has extensive experience particularly in phase II-IV clinical trials, working on both investigator initiated studies and with pharmaceutical companies.  She has valuable experience and knowledge in trial coordination, scientific research, and good clinical practice. Sharon’s focus is to produce high quality data and provide optimal patient care.

Julie-Anne Marshall

Julie-Anne Marshall joined the Gallipoli Medical Research Foundation as a Data Manager in July 2016. With 10 years’ experience in Data Management, Julie-Anne ensures the meticulous recording of all participant data and source documentation within our Clinical Trials Unit.

Jesse Peet

Jesse Peet joined the Foundation in January 2017 as a Clinical Trial Coordinator. Jesse had been involved in clinical trial research for a number of years and has a scientific background in biotechnology and biochemistry. Jesse has extensive experience particularly in phase I-III clinical trials, working with a Phase I unit and a number of research organisations. He has valuable experience and knowledge in scientific research, trial coordination and good clinical practice. Jesse’s aim of ensuring high quality data is produced that meets protocol and Good Clinical Practice standards.

Alice Lau

Alice Lau joined the Foundation in January 2017 as a Clinical Trial Coordinator. Alice had been involved in clinical trial research for 9 years and has a scientific background in dietetics and public health. Alice has extensive experience particularly in phase I-III clinical trials, working with a Phase I trial unit and an oncology unit across two organizations.  She has valuable experience and knowledge in clinical trials and good clinical practice. Alice aim is to provide high standard patient care and obtain quality data.

 

Studies open for recruitment

 

Liver studies

1. Protocol: 747-303.
Short Title: The REGENERATE Study.

Protocol Title: A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis.

Lay Title: Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment (REGENERATE)

2. Protocol: 747-302.

Protocol Title: A Phase 3b, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Effect of Obeticholic Acid on Clinical Outcomes in Subjects with Primary Biliary Cirrhosis

Lay Title: Effect of Obeticholic Acid (OCA) on Outcomes in People with Primary Biliary Cirrhosis (PBC)

Oncology studies

1. Protocol: CA209-742

Protocol Title: Phase IIIb, Randomized, Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects with Previously Untreated Unresectable or Metastatic Melanoma.

Lay Title: A Study to Test a New Drug Treatment, Nivolumab and Ipilimumab, in Participants With Previously Untreated, Unresectable or Metastatic Melanoma.

2. Protocol: EMR200647-001

Protocol Title: A Phase I, open-label, multiple-ascending dose trial to investigate the safety, tolerability, pharmacokinetics, biological and clinical activity of MSB0011359C in subjects with metastatic or locally advanced solid tumors and expansion to selected indications.

Lay Title: MSB0011359C (M7824) in Metastatic or Locally Advanced Solid Tumors

3. Protocol: EMR 100070-007

Protocol Title: A Phase III open-label, multicenter trial of maintenance therapy with avelumab[1] (MSB0010718C) versus continuation of first-line chemotherapy in subjects with unresectable, locally advanced or metastatic, adenocarcinoma of the stomach, or of the gastro-esophageal junction.

Short Title: Evaluating a new investigational drug, Avelumab (MSB0010718C) in participants with advanced cancer of the stomach, or of the gastro-esophageal junction (GEJ), who have not yet received chemotherapy for the treatment of metastatic or locally advanced disease.

4. Protocol: EMR100070-005

Protocol Title: A Phase III, Open-label, Multicenter Trial of Avelumab (MSB0010718C) Versus Platinum-based Doublet as a First-line Treatment of Recurrent or Stage IV PD-L1+ Non-small Cell Lung Cancer

Short Title: Avelumab in First-line Non-Small Cell Lung Cancer (JAVELIN Lung 100)

5. Protocol: IMP321-P012

Protocol Title: TACTI-mel (Two ACTive Immunotherapeutics in melanoma): A multicentre, open label, dose escalation, Phase 1 study in patients with unresectable or metastatic melanoma receiving IMP321 (LAG-3Ig fusion protein) as an adjunctive therapy to anti-PD-1 therapy with pembrolizumab.

Short Title: Phase I Study of IMP321 plus pembrolizumab in melanoma.

6. Protocol: MK-3475-022. KEYNOTE-022

Protocol Title: A Phase I/II Study to Assess the Safety and Efficacy of MK-3475 in Combination with Trametinib and Dabrafenib in Subjects with Advanced Melanoma.

Lay Title: A study to investigate MK-3475 (pembrolizamab) in combination with trametinib and dabrafenib in patients with advanced melanoma.

7. Protocol: CPDR001F2301

Protocol Title: A randomized, double-blind, placebo-controlled, phase III study comparing the combination of PDR001, dabrafenib and trametinib versus placebo, dabrafenib and trametinib in previously untreated patients with unresectable or metastatic BRAF V600 mutant melanoma

Lay Title: A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma.