Clara’s clinical trial journey
Physiotherapist and PhD student Lydia Chen has always enjoyed working with spinal cord injury patients. “You are using so many different skills,” she says. “You always have to put your thinking cap on in terms of how to manage patients.” Unfortunately, there is little research into treatments. “With spinal cord injury, it hasn’t really been proven that there’s that same level of neuroplasticity in the spinal cord, compared to the stroke and brain injury world.” In 2017, Lydia conducted a randomised controlled trial to determine the effect of 10,000 voluntary contractions on the strength of very weak muscles in 120 people with spinal cord injury. She says she was never worried about joining a clinical trial. “Every drug needs people to try it and if you don’t try it, we will never know if they work.” Trials coordinator Rhonda sees Clara regularly to monitor how she is going and undertakes a range of medical and administrative tasks for the trial. She checks her vital signs, collects blood samples, does an electrocardiogram, discusses any adverse events and records any changes to medication. Run across seven hospitals in Australia and Asia over an eight-week period, the research, published in 2020, found the contractions had no benefit. “It was an important question to know — even though we didn’t find a very strong conclusion,” she says. “It was good for the therapists to know not to spend time on doing repetitive exercises, when we could be concentrating on other goals.” “Patients like Clara are generally very motivated on the trials. Especially with this drug we’re trialling at the moment, some patients are doing brilliantly. They are living life normally, five years down the track. They are very stable.” Lydia next study investigated adding electrical stimulation to weakened muscles. Again, she Rhonda has worked on a variety of clinical trials for over 25 years and since 2006, has focused on thyroid cancer trials. The department has studied four different drugs and one of them is now listed on the Pharmaceutical Benefits Scheme. Clara Kam has been taking part in a clinical trial of a potential new treatment for cholangiocarcinoma for the past 18 months at Royal North Shore Hospital. She has been under the care of Associate Professor Venessa Tsang and Rhonda Siddall, a clinical trials coordinator in the Department of Endocrinology. “I was very happy, definitely very happy to be on a trial because I thought there were no other treatments available after the standard chemotherapy,” says Clara. “I didn’t know how long I would have had but I hoped that this drug would help.”
found the patients did not experience a lot of added benefit. She hopes to continue working as both a physiotherapist and researcher. “I can see the advantages of having clinicians being a part of running those research clinical trials, because then we can really apply what we feel are the most important questions,” she says. Endocrinologist Venessa joins Clara’s check-up, and the pair discuss how she is going. During each consultation, she reviews any potential new adverse effects and conducts clinical assessments to evaluate the disease’s response to the trial medication. Lydia also feels like conversations she has with patients are well informed. “It’s their decision what treatments they want to pursue down the track, but at least I know that my advice and the treatments we are discussing are evidence- based.” “As clinicians, we always make sure our patients understand what is involved in being on a trial and that generally, they are a good idea,” Venessa says. “We don’t generally get involved in trials that we don’t think are actually going to benefit the patient.” She says clinical trials are crucial as they allow the department to provide early access to new treatments for patients, gather valuable data and help shape future treatment protocols. “It’s a win- win situation,” she says. She enjoys trials as she gets to know patients. Clara attends her appointments with her daughter-in-law Shirley who helps with translation. “You get know each other’s family situations. Shirley was asking me about my mum today and I was asking her about her kids,” says Rhonda.
Associate Professor Venessa Tsang, Clara Kam and Rhonda Siddall
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