The Clinical Trials Centre at the Monash Health Translation Precinct (MHTP) welcomed its first overnight patient earlier this month.
Mr Rudy Van Ekeren is the second aggressive B-cell lymphoma patient in Australia—and only the 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.