MHTP Clinical Trials Centre a unique Australian resource

Clinician researchers at the newly opened MHTP Clinical Trials Centre celebrated International Clinical Trials Day last Friday.

Held on 20 May, the event commemorates the day that James Lind began his trials into the causes of scurvy.  Lind's experiments in 1747 on board the HMS Salisbury were run under very different conditions to today.

The state-of-the-art Clinical Trials Centre (CTC) at the Monash Health Translation Precinct (MHTP) provides a ‘home base’ for Monash Health clinician-scientists to conduct early, mid and late phase clinical trials.  Supported by a dedicated clinical trial pharmacy and pathology centre, the CTC pharmacy and pathology staff understand the specific requirements of trial protocols. 

Clinical Trials Centre team at MHTP

”The CTC provides a resource that is available nowhere else in Australia,” said Clinical Lead for the MHTP Clinical Trial Centre Professor William Sievert.

The Centre includes access to chairs for study subjects requiring timed infusions of investigational new drugs and overnight facilities for participants in detailed pharmacokinetic studies.

“Every detail is watched over by clinical trial nurses who ensure that trial protocols are strictly followed while providing care for their study subjects,” said Professor Sievert, who is also Director, Gastroenterology and Hepatology Unit, Monash Health and a Research Group Head in the Centre for Inflammatory Diseases at Monash University.

Since opening late last year, 416 patients have visited the CTC, participating in 83 different clinical trials from 12 trial units, including haematology, oncology, lung & sleep, gastro/liver, diabetes, infectious diseases, gastro IBD, rheumatology, neurology, stroke, emergency and endocrinology. 

“Our clinical research group is focused on treatment for viral hepatitis, hepatocellular carcinoma in addition to care pathways for patients with end-stage liver disease,”said Professor William Sievert.

“We have taken part in studies that have developed new, non-interferon based therapy for hepatitis C that cures more than 90% of patients who are treated.” 

MHTP clinician-researchers are also starting studies that will look at curing hepatitis B, which currently can be controlled but not cured. 

Head of Haematology Research at SCS and consultant haematologist at Monash Health, Associate Professor Jake Shortt is involved in clinical trials for patients with cancers of the blood and bone marrow such as leukaemia, lymphoma and multiple myeloma.

"We use trials as a means to access promising medications for patients in need where they may not be available through the PBS."

Associate Professor Shortt said that in haematology there are a lot of new and effective high cost drugs that are not necessarily available. 

"These drugs often provide a more effective alternative to conventional treatment, including 'chemo-free' regimens. Our studies seek to improve treatment outcomes in patients while saving the hospital system money at the same time."

Medical Oncologist and Head of Phase 1 Clinical Trials Group Dr Ben Markman runs clinical trials in cancer patients, testing new drugs that are early in development.

"We look at the safety of these compounds and how the body reacts to and handles the drugs," said Dr Markman.

"We provide opportunities for cancer patients where there may be no other options or the existing options are inadequate."

 "The MHTP and CTC provides a state-of-the art facility that allows patients to be treated safely and comfortably on these clinical trials."

A truly translational facility, the CTC tackles all phases of trials.

“We have multiple units utilising the floor; we are just not giving Chemo,” said MHTP Clinical Trials Centre Manager Ms Cheryl Coleman.  “We started out with 5 and currently have 11 with two more starting soon with us.”

The CTC provides a hybrid model of care, with both primary and team nursing utilised. The space is shared, as is the experience and skills of the staff.

“We offer a one stop shop: outpatient consults, treatment areas, a dedicated trials pharmacy and a dedicated trials lab all on the same floor,” said Ms Coleman.  

             

The CTC at MHTP accepts trials from Monash Health, Monash University and the Hudson Institute will soon commence work for commercial businesses wanting to bring their technology to the patients.