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| Mr Rudy Van Ekeren with Ms Cheryl Coleman |
The Clinical Trials Centre at the Monash Health Translation
Precinct (MHTP) welcomed their first overnight patient earlier this month.
Mr Rudy Van Ekeren is the second aggressive B-cell lymphoma
patient in Australia—and only third in the world—to receive a novel epigenetic
therapy as part of an anti-lymphoma clinical trial. The study is being led by Monash University
researcher and Monash Health haematologist Dr Gareth Gregory.
“I’ve been in hospitals around the world and have never seen
facilities like this,” said Rudy.
For the first cycle of his trial, Rudy needed to have ten
hours of pre-hydration before starting his treatment.
“We needed him here overnight so we could start his
treatment in the morning,” said MHTP Clinical Trials Centre (CTC) Manager Ms Cheryl
Coleman.
“Once Rudy started his treatment, we began our observations
and a series of blood tests
looking for tumour lysis syndrome to make sure the tumour wasn’t breaking down
in a dangerous manner.”
Rudy stayed for a second night in the CTC for further
observations.
According to Early Phase Drug Trials Operations Manager Ms
Cheryl-Ann Hawkins, the first overnight patient in the CTC marks the beginning
of a new service and a new era.
“While there are other healthy volunteer clinical trials
units in Australia, our CTC is unique in that it offers services across all
diseases and phases in unhealthy patients,” said Ms Hawkins.
Ms Coleman said that one of the biggest advantages of the
CTC is the Trial Units no longer have to negotiate for a public hospital bed.
“When following a clinical trial protocol, we may only have
28 days for a screening period, and patients must be treated at Day 0 or Day
1,” said Ms Coleman.
“When you’re competing for a public hospital bed in a busy
ward, there can often be a delay of a day or two and there’s a chance of losing
the patient to the trial.”
“When patients come to our dedicated Centre we can guarantee
they’re looked after according to the protocol requirements. Data is collected
and recorded at the required time points.”
Ms Coleman said the CTC is not only more attractive to
sponsors by providing timely and accurate data but also allows trial units to
participate in new trials they would not have been able to consider previously.
For patient Rudy, he was happy to have all the attention of
the night shift staff.
“I couldn’t wish for any better treatment, and I was very
happy having my wife stay overnight in the room to support me,” he said.
The unique and dedicated Clinical Trials Centre is an
Australian first in the public sector, supporting clinical trials from Phase
1 to Phase 4—from ‘first in human’ to primary health trials.
